A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (Dendrimer N-acetyl-cysteine) in Patients With Severe COVID-19

The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19.
The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients.
A further secondary objective of Stage 2 of this study is:
To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.

开始日期2020-08-11

申办/合作机构

Ashvattha Therapeutics Inc初创企业

NCT04321980 / Completed临床1期

A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-acetyl-cysteine) After Subcutaneous Administration in Healthy Volunteers

A clinical study to measure the Safety, Tolerability, and Pharmacokinetics of OP-101 After Subcutaneous Administration in Healthy Volunteers

开始日期2020-03-19

申办/合作机构

Orpheris, Inc.

NCT03500627 / Completed临床1期

A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-Acetyl-Cysteine) After Intravenous Administration in Healthy Volunteers

A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.

开始日期2018-03-30

申办/合作机构

Orpheris, Inc.

100 项与 OP-101 相关的临床结果

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100 项与 OP-101 相关的转化医学

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100 项与 OP-101 相关的专利（医药）

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项与 OP-101 相关的文献（医药）

2022-07-20·Science translational medicine

Dendrimer nanotherapy for severe COVID-19 attenuates inflammation and neurological injury markers and improves outcomes in a phase2a clinical trial.

Article

作者: Aaron M Gusdon ; Nauder Faraday ; John S Aita ; Sunil Kumar ; Ishan Mehta ; HuiMahn A Choi ; Jeffery L Cleland ; Keith Robinson ; Louise D McCullough ; Derek K Ng ; Rangaramanujam M Kannan ; Sujatha Kannan

Hyperinflammation triggered by SARS-CoV-2 is a major cause of disease severity, with activated macrophages implicated in this response. OP-101, a hydroxyl-polyamidoamine dendrimer-N-acetylcysteine conjugate that specifically targets activated macrophages, improves outcomes in preclinical models of systemic inflammation and neuroinflammation. In this multicenter, randomized, double-blind, placebo-controlled, adaptive phase 2a trial, we evaluated safety and preliminary efficacy of OP-101 in patients with severe COVID-19. Twenty-four patients classified as having severe COVID-19 with a baseline World Health Organization seven-point ordinal scale of ≥5 were randomized to receive a single intravenous dose of placebo (n = 7 patients) or OP-101 at 2 (n = 6), 4 (n = 6), or 8 mg/kg (n = 5 patients). All study participants received standard of care, including corticosteroids. OP-101 at 4 mg/kg was better than placebo at decreasing inflammatory markers; OP-101 at 4 and 8 mg/kg was better than placebo at reducing neurological injury markers, (neurofilament light chain and glial fibrillary acidic protein). Risk for the composite outcome of mechanical ventilation or death at 30 and 60 days after treatment was 71% (95% CI: 29%, 96%) for placebo and 18% (95% CI: 4%, 43%; P = 0.021) for the pooled OP-101 treatment arms. At 60 days, 3 of 7 patients given placebo and 14 of 17 OP-101-treated patients were surviving. No drug-related adverse events were reported. These data show that OP-101 was well tolerated and may have potential to treat systemic inflammation and neuronal injury, reducing morbidity and mortality in hospitalized patients with severe COVID-19.

2020-12-01·Journal of Molecular Liquids2区 · 化学

Interaction of N-acetyl--cysteine with Na, Ca, Mg and Zn. Thermodynamic aspects, chemical speciation and sequestering ability in natural fluids

2区 · 化学

Article

作者: Bretti, Clemente ; Cardiano, Paola ; Irto, Anna ; Lando, Gabriele ; Milea, Demetrio ; Sammartano, Silvio

The estimation of thermodynamic parameters of N-Acetyl-L-cysteine (NAC) protonation were determined in NaCl_(aq), (CH₃)₄NCl_(aq), (C₂H₅)₄NI_(aq), employing various temperature and ionic strengths conditions, by potentiometric measurements. The interaction of NAC with some essential metal cations (e.g., Ca²⁺, Mg²⁺ and Zn²⁺) was investigated as well at 298.15 K in NaCl_(aq) in the ionic strength range 0.1 ≤ I/mol dm^-3 ≤ 1.0. The values of protonation constants at infinite dilution and at T = 298.15 K are: log K ₁ ^H = 9.962 ± 0.005 (S-H) and log K ₂ ^H = 3.347 ± 0.008 (COO-H). In the presence of a background electrolyte, both log K ₁ ^H and log K ₂ ^H values followed the trend (C₂H₅)₄NI ≥ (CH₃)₄NCl ≥ NaCl. The differences in the values of protonation constants among the three ionic media were interpreted in terms of variation of activity coefficients and formation of weak complexes. Accordingly, the determination of the stability of 4 species, namely: NaL^-, NaHL⁰ _(aq), (CH₃)₄NL^-, (CH₃)₄NHL⁰ _(aq) was assessed. In addition, as regards the interactions of Mg²⁺, Ca²⁺ and Zn²⁺ with NAC, the main species where the ML⁰ _(aq), ML(OH)^-, and ML₂ ^2-, that were found to be important in the chemical speciation of NAC in real multicomponent solutions. The whole set of the data collected may be crucial for the development of NAC-based materials for natural fluids selective decontamination from heavy metals.

2020-09-16·Journal of Agricultural and Food Chemistry1区 · 农林科学

Investigation of the Interaction between N-Acetyl--Cysteine and Ovalbumin by Spectroscopic Studies, Molecular Docking Simulation, and Real-Time Quartz Crystal Microbalance with Dissipation

1区 · 农林科学

Article

作者: Wang, Junyi ; Dadmohammadi, Younas ; Jaiswal, Archana ; Abbaspourrad, Alireza

This study investigated the interaction between N-acetyl-l-cysteine (NAC) and ovalbumin (OVA) using multispectroscopic technology, molecular docking, and quartz crystal microbalance with dissipation (QCM-D). Fluorescence intensity and UV absorption of OVA were decreased substantially upon the addition of NAC. The calculated K_q values were obtained at 298, 304, and 310 K for 13.48, 15.59, and 17.50 (× 10¹² L mol^-1), respectively, suggesting that the static quenching was dominated. Thermodynamic parameters such as ΔH (-150.58 kJ mol^-1), ΔS (-433.51 J mol^-1 K^-1), and ΔG values (-21.39 kJ mol^-1), combined with molecular docking and QCM-D data, showed that the interaction was spontaneous and van der Waals and hydrogen bonding were identified as the main driving forces. FTIR and CD results showed that the α-helix content of OVA increased from 2.8 to 22.9%, and the β-sheet decreased from 0.2 to 21.9% in the presence of 5 and 10 μM NAC, respectively, compared to the pure OVA, respectively.

项与 OP-101 相关的新闻（医药）

2022-11-08

·PRNewswire

Extremely Robust COVID-19 Clinical Trial Pipeline With 420+ Key Companies Expected to Change the Pace of the COVID-19 Treatment

COVID-19 clinical trial pipeline constitutes 420+ key companies continuously working towards developing 520+ COVID-19 vaccines and drugs, analyzes DelveInsight LAS VEGAS, Nov. 8, 2022 /PRNewswire/ -- DelveInsight's ' COVID-19 Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline COVID-19 vaccines in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the COVID-19 competitive domain. Key Takeaways from the COVID-19 Pipeline Report Over 420+ COVID-19 companies are evaluating 520+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue. Leading COVID-19 companies such as Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others are evaluating novel drugs for COVID-19 to improve the treatment landscape. Key COVID-19 pipeline therapies in various stages of development include XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. In October 2022, eFFECTOR Therapeutics announced the completion of enrollment for the second cohort of a three-cohort Phase Ib clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. In October 2022, Pfizer/BioNTech and Moderna's bivalent COVID-19 booster vaccines targeting the BA.4 and BA.5 subvariants of Omicron have been approved for use in children and adolescents in the United States. In October 2022, an intranasal formulation of AstraZeneca's widely used COVID-19 vaccine, Vaxzevria, failed at the first hurdle, with results from a phase I trial revealing that it was unable to stimulate a strong immune response to the virus. In September 2022, Bharat Biotech's Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC became the world's first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company's U.S. Food & Drug Administration ("FDA") Phase III clinical trial (the "Study") (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the "Data") to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data, and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date In April 2022, Direct Biologics announced that the US Food and Drug Administration (FDA) had awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. In March 2022, Akston Biosciences Corp and Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence, and established relationships Request a sample and discover the recent advances in COVID-19 treatment @ COVID-19 Competitive Landscape Report COVID-19 Overview Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered coronavirus, SARS coronavirus 2. (SARS-CoV-2). COVID-19 causes a respiratory illness similar to the flu. The COVID-19 symptoms include cough, fever, and difficulty breathing. The majority of people infected with the COVID-19 virus will experience mild to moderate respiratory illness and will recover without the need for special care. People over the age of 65 and those with underlying medical conditions such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illnesses. When an infected person coughs or sneezes, the COVID-19 virus is primarily transmitted through saliva or nasal discharge droplets. Discover more about COVID-19 testing @ New Treatment for COVID-19 COVID-19 Pipeline Analysis: Drug Profile Sargramostim: Nobelpharma Nobelpharma's drug Sargramostim is a synthetic version of a natural substance produced in the body. It is used to boost the body's production of white blood cells. Sargramostim is given to patients with decreased ability to produce white blood cells. It is also used in some medical procedures (for example, bone marrow/stem cell transplants). It is a supportive medication but does not aid cancer treatment. The product is currently in Phase II/III development for the treatment of COVID-19. Sotrovimab: Vir Biotechnology Vir Biotechnology's Sotrovimab is a monoclonal antibody that neutralizes SARS-CoV-2. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance development more difficult. Sotrovimab, which incorporates Xencor, Inc.'s XtendTM technology, has also been designed to achieve high concentrations in the lungs for optimal penetration into SARS-CoV-2-affected airway tissues and to have an extended half-life. Discover more about the list of FDA-approved drugs for COVID-19 @ Antiviral Drugs for COVID-19 Treatment A snapshot of the COVID-19 Pipeline Drugs mentioned in the report: Learn more about the emerging COVID-19 pipeline therapies @ COVID-19 Clinical Trials Scope of the COVID-19 Competitive Landscape Report Coverage: Global Key COVID-19 Companies: Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others Key COVID-19 Pipeline Therapies: XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. Dive deep into rich insights for drugs for COVID-19 treatment; visit @ COVID-19 Vaccines Table of Contents For further information on the COVID-19 guidelines, reach out @ COVID-19 Treatment Guidelines Related Reports COVID-19 Pipeline COVID-19 Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COVID-19 companies, including Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, among others. Common Cold Market Common Cold Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Pipeline Common Cold Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Epidemiology Common Cold Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted common cold epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key acute respiratory distress syndrome companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic obstructive pulmonary disease companies, including United Therapeutics, Verona Pharma PLC, AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, among others. 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疫苗基因疗法抗体生物类似药细胞疗法

2022-08-11

·Science Daily

Nanoparticle therapy may help patients hospitalized with severe COVID-19 infections

Researchers say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19. Johns Hopkins Medicine researchers say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19. Results of the small clinical trial, funded by Ashvattha Therapeutics, a Johns Hopkins startup company that makes the drug, specifically found that patients who received the drug had a greater than fourfold higher rate of decrease in biomarkers of inflammation and brain injury circulating in their blood compared with patients who received a placebo. A report on the study was published July 20 in Science Translational Medicine. "OP-101 could be a potent therapy for decreasing hyperinflammation and promoting repair in people with severe COVID, showing significant clinical benefit without the associated side effects typically seen with some other treatments," says Sujatha Kannan, M.B.B.S., professor of anesthesiology and critical care medicine and pediatrics at the Johns Hopkins University School of Medicine. Kannan and her husband, Kannan Rangaramanujam, Ph.D., professor of ophthalmology at the Johns Hopkins University School of Medicine and Wilmer Eye Institute, Johns Hopkins Medicine, developed OP-101 by attaching a powerful antioxidant/anti-inflammatory drug known as n-acetyl cysteine (NAC) to a nanoparticle that is 100,000 times smaller than the thickness of a sheet of paper. Each nanoparticle has a number of molecules of the drug attached to it, and can deliver the drug specifically to inflammatory cells called macrophages. The dendrimer nanoparticle delivers the drug to only those macrophages involved in inflammation at the site of injury. Currently, NAC is used in a different form to treat acetaminophen poisoning and for thinning mucus secretions in airways. The pair of researchers are co-inventors on patents related to the drug's discovery, and founded a biotechnology company, Ashvattha Therapeutics Inc., based in California, to develop the drug and fund clinical trials. The company licenses the technology through Johns Hopkins Technology Ventures. The researchers caution that larger clinical trials of OP-101 must be completed, and that OP-101 should be used to treat COVID-19 only in a clinical trial or, for other medical needs, with the supervision of a physician. For the study, researchers recruited 24 patients between the ages of 43 and 86, mostly male (five Black, 15 Hispanic and four non-Hispanic white) with severe COVID-19 admitted to hospitals between August 2020 and May 2021 within five medical systems located in five states in the U.S., including The Johns Hopkins Hospital. Patients with signs of severe COVID-19 who were on mechanical ventilation or on oxygen through high-flow nasal cannula were eligible to be enrolled in the study. The majority of patients included in the study were in the intensive care unit. Six patients received a single intravenous 2 mg/kg dose of OP-101; six received a 4 mg/kg dose; five received an 8 mg/kg dose and seven received a saline placebo within 24 hours of enrollment. All 24 patients also received standard care for COVID-19, including corticosteroids used to suppress inflammation and the antiviral drug remdesivir. The investigators were not aware which patients received placebo or OP-101 until the end of the study. At the conclusion of the trial, the researchers found that OP-101, at a dosage of either 4 mg/kg or 8 mg/kg, was sixfold better at reducing the inflammation marker C-reactive protein, and fourfold to tenfold better at reducing biomarkers of neurologic injury such as neurofilament light and glial fibrillary acidic protein. The risk of death or needing a ventilator at 30 and 60 days after treatment was 71% for patients who received the placebo and 18% for those receiving OP-101. At 60 days after receiving either OP-101 or the placebo, 3 of 7 patients who received the placebo and 14 of 17 patients who received any of the three doses of OP-101 had survived. OP-101 was not associated with any adverse events, and was well tolerated in this critically ill population. "It is possible that OP-101 may also be useful in treating the neurologic, cardiac and respiratory symptoms associated with long COVID, since a proportion of patients with long COVID have persistent inflammation," says Rangaramanujam Kannan. The researchers are planning larger clinical trials of OP-101. Other contributors to the research include Aaron Gusdon, HuiMahn Choi and Louise McCullough from the University of Texas; Nauder Faraday, Derek Ng and Kannan Rangaramanujam from Johns Hopkins; John Aita from Avera McKennan Hospital; Sunil Kumar from Broward Health Medical Center; Ishan Mehta from Emory University; Jeffery L. Cleland from Ashvattha Therapeutics Inc. and Keith Robinson from Syneos Health. The study was funded by Ashvattha Therapeutics Inc. Under licensing agreements between Ashvattha Therapeutics, LLC and The Johns Hopkins University, Sujatha Kannan, Kannan Rangaramanujam, and the university are entitled to royalty distributions and share ownership related to technology discussed in this press release. Kannan and Rangaramanujam are founders of and hold equity in Ashvattha Therapeutics, LLC. This arrangement has been reviewed and approved by The Johns Hopkins University in accordance with its conflict of interest policies. The study discussed in this press release was also materially supported by Ashvattha Therapeutics, LLC. Derek Ng is a paid consultant to Ashvattha Therapeutics, LLC.

2022-07-25

·BioSpace

Ashvattha Therapeutics Announces Publication of Data in Science Translational Medicine from Phase 2a Clinical Trial for OP-101 in Severe COVID-19

REDWOOD CITY, Calif., July 25, 2022 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical stage company developing novel hydroxyl dendrimer therapeutics, today announced the publication of the results from a Phase 2a clinical study demonstrating a significant reduction in inflammatory and neuroinflammatory markers and improved clinical outcomes with OP-101, a hydroxyl dendrimer therapeutic (HDT), delivered intravenously in patients with severe COVID-19. The paper, titled, “Dendrimer nanotherapy for severe COVID-19 attenuates inflammation and neurological injury markers and improves outcomes in a phase 2a clinical trial,” was published in the peer-reviewed scientific journal Science Translational Medicine. The Phase 2a trial (PRANA), a multi-center, double-blind, placebo-controlled, single sequential, ascending dose study, evaluated the safety, tolerability and preliminary efficacy of OP-101 intravenously dosed at 2 mg/kg, 4 mg/kg and 8 mg/kg across three cohorts compared to a single intravenous dose of placebo in patients with severe COVID-19. Key findings published in Science Translational Medicine include: OP-101 was shown to improve survival, corresponding with an increase in dosage (2 mg/kg: 67%; 4 mg/kg: 100%; 8 mg/kg: 80%) versus placebo (43%). Risk for the composite outcome of mechanical ventilation or death at 30 and 60 days after treatment was 71% for placebo and 18% for the pooled OP-101 treatment arms. At 60 days, three of seven patients given placebo and 14 of 17 OP-101 treated patients were surviving, and the surviving patients treated with OP-101 did not require mechanical ventilation by day 30 or day 60. Treatment with OP-101 was associated with attenuating neuronal injury markers NfL and GFAP, lasting until day 30 of the study. OP-101 dosed at 4 mg/kg treatment significantly decreased markers of hyperinflammation TNF-α, IL-6 and IL-8. No drug-related adverse events were reported. “We are incredibly pleased with these positive results that support the potential of OP-101 to significantly improve clinical outcomes and survival for patients with severe COVID-19,” said Jeffrey Clelland, Ph.D., Chairman & CEO of Ashvattha Therapeutics. “This data also validates the ability of our hydroxyl dendrimer therapies to cross tissue barriers, including blood-brain barriers, selectively targeting areas of inflammation with an excellent safety profile, which could benefit patients with other diseases characterized by inflammation. We are hopeful that we may see similar results in patients suffering from Long COVID.” This paper was published in its entirety in volume 14, issue number 654 of Science Translational Medicine and can be accessed here. About OP-101 OP-101 is an HDT with N-acetyl cysteine (NAC) that selectively targets reactive macrophages and microglia, which are responsible for hyperinflammation, lung injury and multi-organ failure caused by viral or bacterial infections, including COVID-19. About Ashvattha Therapeutics Ashvattha Therapeutics is a clinical-stage biotech company developing novel hydroxyl dendrimer therapeutics (HDTs) targeting unmet medical needs in ophthalmology, neurology, inflammatory diseases and neuro-oncology. The therapies are based on hydroxyl dendrimers (HDs), a targeted platform technology exclusively licensed from our founders, Kannan Rangaramanujam and Sujatha Kannan at Johns Hopkins University. HDs chemically conjugated to disease-modifying drugs create novel proprietary HD therapeutics (HDTs) selectively targeting reactive inflammatory cells in disease tissue with localized sustained effects. Ashvattha has initiated multiple programs with HDTs focused on neurology, ocular neovascular disease including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME), and hyperinflammation in diseases. For more information, visit: . Media Contact Jordyn Temperato LifeSci Communications jtemperato@lifescicomms.com

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研发状态

适应症	最高研发状态	国家/地区	公司
新型冠状病毒感染	临床2期	美国更多	Orpheris, Inc. 更多
炎症	临床2期	美国更多	Ashvattha Therapeutics Inc初创企业更多
肾上腺脑白质营养不良	临床1期	澳大利亚更多	Orpheris, Inc. 更多
帕金森病	临床前	美国更多	Orpheris, Inc. 更多

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04458298 (PRANA, Pubmed) 人工标引	临床2期	新型冠状病毒感染 \| 炎症 \| 神经系统损伤	24	OP 101	(淵衊鹹繭鹽觸鬱顧壓膚) = 獵遞鑰膚餘廠鑰鏇餘鏇齋選壓選襯顧製淵網衊 (願簾製壓鏇餘選廠夢網, 29 ~ 96) 更多	积极	2022-07-20
				Placebo	(淵衊鹹繭鹽觸鬱顧壓膚) = 繭簾廠築淵鏇選網夢蓋齋選壓選襯顧製淵網衊 (願簾製壓鏇餘選廠夢網, 4 ~ 43) 更多
NCT04458298 (PRANA, Corporate Publications) 人工标引	临床2期	新型冠状病毒感染 NfL	24	OP-101	(憲鹹遞窪夢繭壓簾壓憲) = 獵網觸製鏇繭壓憲醖鏇糧壓糧廠構蓋獵廠鑰廠 (顧鹽艱廠壓憲範齋鑰範 ) 更多	积极	2021-06-15
				Placebo+Standard of Care	(憲鹹遞窪夢繭壓簾壓憲) = 夢蓋顧窪製窪蓋鹹積觸糧壓糧廠構蓋獵廠鑰廠 (顧鹽艱廠壓憲範齋鑰範 ) 更多
NCT04321980 (CTgov)	临床1期	-	8	OP-101 (Cohort 1: 4 mg/kg)	(蓋觸夢艱鏇顧繭淵鬱積) = 壓襯製製獵憲鹽夢齋鹽鏇網構淵膚遞範構獵製 (廠艱顧膚獵鬱積鑰餘齋, 繭齋醖糧築齋艱製積顧 ~ 夢願築襯顧積壓糧築願) 更多	-	2021-06-14
				OP-101 (Cohort 2: 8 mg/kg)	(蓋觸夢艱鏇顧繭淵鬱積) = 鹹獵糧夢窪壓衊蓋糧襯鏇網構淵膚遞範構獵製 (廠艱顧膚獵鬱積鑰餘齋, 夢齋醖積遞鑰齋壓繭網 ~ 憲鬱鏇顧願衊選蓋積網) 更多