A two-part, randomized, double-blind, multi-center, placebo-controlled study of the dose-range, safety and efficacy of 4 and 12 weeks of treatment with AP1189 in adult rheumatoid arthritis (RA) patients with an inadequate response to Methotrexate (MTX) alone - RESOLVE - RESOLVE

开始日期2022-12-22

申办/合作机构

SynAct Pharma ApS

NCT05604885 / Recruiting临床2期

A Two-part, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Dose-range, Safety and Efficacy of 4 and 12 Weeks of Treatment With AP1189 in Adult Rheumatoid Arthritis (RA) Patients With an Inadequate Response to Methotrexate (MTX) Alone - (RESOLVE)

The RESOLVE study is a two-part, randomized, double-blind, multi-center, placebo-controlled study of the safety, dose-range finding confirmation, and efficacy of 4 (Part A) and 12 weeks (Part B) of treatment with AP1189 in adult RA patients with an inadequate response to MTX alone.

开始日期2022-11-30

申办/合作机构

SynAct Pharma ApS

[+1]

NCT05516979 / Completed临床2期

A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment

The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).

开始日期2022-09-26

申办/合作机构

SynAct Pharma ApS

[+1]

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项与 SynAct Pharma AB 相关的文献（医药）

2022-01-01·Seminars in Immunology2区 · 医学

Translational advances of melanocortin drugs: Integrating biology, chemistry and genetics

2区 · 医学

Review

作者: Jonassen, Thomas E N ; Boesen, Thomas ; Montero-Melendez, Trinidad

Melanocortin receptors have emerged as important targets with a very unusual versatility, as their widespread distribution on multiple tissues (e.g. skin, adrenal glands, brain, immune cells, exocrine glands) together with the variety of physiological processes they control (pigmentation, cortisol release, satiety mechanism, inflammation, secretions), place this family of receptors as genuine therapeutic targets for many disorders. This review focuses in the journey of the development of melanocortin receptors as therapeutic targets from the discovery of their existence in the early 1990 s to the approval of the first few drugs of this class. Two major areas of development characterise the current state of melanocortin drug development: their role in obesity, recently culminated with the approval of setmelanotide, and their potential for the treatment of chronic inflammatory and autoimmune diseases like rheumatoid arthritis, multiple sclerosis or fibrosis. The pro-resolving nature of these drugs offers the advantage of acting by mimicking the way our body naturally resolves inflammation, expecting fewer side effects and a more balanced (i.e. non-immunosuppressive) response from them. Here we also review the approaches followed for the design and development of novel compounds, the importance of the GPCR nature of these receptors in the process of drug development, therapeutic value, current challenges and successes, and the potential for the implementation of precision medicine approaches through the incorporation of genetics advances.

British Journal of Pharmacology

Effects of a pro‐resolving drug in COVID‐19: preclinical studies to a randomized, placebo‐controlled, phase Ib/IIa trial in hospitalized patients

Article

作者: Tana, Fernanda L. ; Costa, Vivian V. ; Silva, Barbara L. V. ; Souza, Renan P. ; Fonseca, Talita C. M. ; Alcantara, Katlen M. M. ; Jonassen, Thomas E. N. ; Teixeira, Mauro M. ; Almeida, Pedro R. J. ; Perretti, Mauro ; Avila, Renata E. ; Queiroz‐Junior, Celso M. ; Serufo, Angela V. ; Periard, Alexandre M. ; Resende, Carolina B. ; Milhorato, Larissa B. ; Santos, Felipe R. ; Teixeira, Danielle C.

IntroductionPro‐resolving molecules may curb disease caused by viruses without altering the capacity of the host to deal with infection. AP1189 is a melanocortin receptor‐biased agonist endowed with pro‐resolving and anti‐inflammatory activity. We evaluated the preclinical and early clinical effects of treatment with AP1189 in the context of COVID‐19.MethodsC57BL/6j mice were infected intranasally with MHV‐A59 or hK18‐ACE2 mice with SARS‐CoV‐2. AP1189 (10 mg·kg−1, BID, s.c.) was given to the animals from day 2 and parameters evaluated at day 5. Human PBMCs from health donors were infected with SARS‐CoV‐2 in presence or absence of AP1189 and production of cytokines quantified. In the clinical study, 6 patients were initially given AP1189 (100 mg daily for 14 days) and this was followed by a randomized (2:1), placebo‐controlled, double‐blind trial that enrolled 54 hospitalized COVID‐19 patients needing oxygen support. The primary outcome was the time in days until respiratory recovery, defined as a SpO2 ≥ 93% in ambient air.ResultsTreatment with AP1189 attenuated pulmonary inflammation in mice infected with MHV‐A59 or SARS‐CoV‐2 and decreased the release of CXCL10, TNF‐α and IL‐1β by human PBMCs. Hospitalized COVID‐19 patients already taking glucocorticoids took a median time of 6 days until respiratory recovery when given placebo versus 4 days when taking AP1189 (P = 0.017).ConclusionTreatment with AP1189 was associated with less disease caused by beta‐coronavirus infection both in mice and in humans. This is the first demonstration of the effects of a pro‐resolving molecule in the context of severe infection in humans.

项与 SynAct Pharma AB 相关的新闻（医药）

2024-09-13

·synactpharma

SynAct Pharma to present clinical data on resomelagon (AP1189) at ACR Convergence

SynAct Pharma AB (“SynAct”), a clinical-stage biotechnology company focused on resolving inflammation through selective activation of the melanocortin system, today announced that an abstract for resomelagon (AP1189) has been selected for presentation at the American College of Rheumatology (ACR) Convergence 2024 conference, being held in Washington DC, USA, from November 14 to 19. At the conference SynAct Pharma will present clinical data from the Phase 2b EXPAND study with focus on the treatment potential of resomelagon (AP1189) in newly diagnosed rheumatoid arthritis patients with high disease activity and signs of active inflammation. “We look very much forward to presenting the EXPAND-study clinical data at the ACR Convergence 2024, the world's premier rheumatology event,” said SynAct’s CSO Thomas Jonassen. “The development of resomelagon (AP1189) in the patient population is continued in the Phase 2b ADVANCE study.” Resomelagon is a novel, once-daily tablet with anti-inflammatory and pro-resolving effects with the potential to treat active rheumatoid arthritis. Further information related to the accepted abstract will, due to embargo policies, be shared at a later timepoint when the abstract is published in a special online supplement of the scientific journal Arthritis & Rheumatology. For further information, please contact:Jeppe ØvlesenCEO, SynAct Pharma ABPhone: + 45 2844 7567E-mail: investor.relations@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For more information: www.synactpharma.com. AttachmentsSynAct Pharma to present clinical data on resomelagon (AP1189) at ACR Convergence

临床2期

2024-08-30

·synactpharma

First scientific publication showing treatment potential of a pro-resolving compound in human virus infection

SynAct Pharma AB (“SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnology company focused on resolving inflammation through selective activation of the melanocortin system, today announced the publication of clinical and preclinical data in a scientific journal supporting the potential of the company’s lead compound resomelagon (AP1189) as a novel innovative treatment option to control virus-induced hyper-inflammation, including COVID-19 infection. The peer-reviewed article, published in British Journal of Pharmacology, states it is the first scientific publication in literature showing treatment effects of a pro-resolving molecule in human infection. The major findings in the article are: Resomelagon significantly reduced disease activity in an animal model of betacoronavirus (MHV-A59 virus) induced pulmonary infection and in an animal model of SARS-CoV-2 virus induced pulmonary infection. Resomelagon significantly reduced the pro-inflammatory activity of human peripheral blood mononuclear cells (monocytes and lymphocytes) challenged with SARS-CoV-2 virus. In a randomized clinical trial (the RESOVIR-1 study) in COVID-19 patients, resomelagon significantly reduced time to recovery of respiratory insufficiency (measured on time to normalization of oxygen saturation on ambient respiration) and significantly reduced time to discharge of hospitalization when compared placebo treatment in patients that despite standard treatment, including low dose glucocorticoid treatment, developed severe respiratory insufficiency. “As highlighted in the article, this is the first peer-reviewed scientific report demonstrating the effects of a pro-resolving compound in the context of severe infection in humans,” said Thomas Jonassen, CSO at SynAct Pharma and co-author of the article. “The encouraging results show the potential of resomelagon to re-balance the inflammatory response in severe viral infection, not only seen in COVID-19 infected patients, but in a number of viral infections including severe influenza and dengue fever among others. We will therefore, in parallel with the continued development of the compound in the Phase 2b ADVANCE study in rheumatoid arthritis, continue to investigate the potential of the compound within viral infections in the RESOVIR collaboration.” “I am very happy to see these results. Although our priority is to continue development of resomelagon in RA, these very interesting data create opportunities in other indications with severe virus infections. This further strengthen our possibilities in finding partnerships with Big Pharma, or receiving soft money, to pursue these activities,” said Jeppe Øvlesen, CEO of SynAct Pharma. The publication is based on data generated as part of the RESOVIR collaboration, a scientific and clinical development collaboration between the University of Minas Gerais, Belo Horizonte, Brazil, William Harvey Research Institute, London, UK and SynAct Pharma. Link to the research article in the British Journal of Pharmacology:https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bph.17322 or through Pub Med:https://pubmed.ncbi.nlm.nih.gov/39159951/ For further information, please contact:Jeppe ØvlesenCEO, SynAct Pharma ABPhone: + 45 2844 7567E-mail: investor.relations@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For more information: www.synactpharma.com. AttachmentsFirst scientific publication showing treatment potential of a pro-resolving compound in human virus infection

临床2期临床结果

2024-08-20

·synactpharma

SynAct Pharma publishes Q2 2024 interim results

SynAct Pharma AB (publ) (“SynAct”) today publishes the interim report for the second quarter 2024 and first six months. The Group’s net sales amounted to SEK 0 (0) thousand. Operating expenses amounted to SEK 19,167 (43,495) thousand, a decrease of 56%. The Group’s loss after tax amounted to SEK 18,628 (43,511) thousand. The Group’s earnings per share before and after dilution amounted to SEK -0.47 (-1.37). Cash flow from operating activities amounted to SEK -36,153 (-34,657) thousand. Cash flow from financing activities amounted to SEK 47,483 (-179) thousand. Cash flow for the period amounted to SEK 11,331 (-34,704) thousand. Cash and cash equivalents at the end of the period amounted to SEK62,799 (44,421) thousand. The Group’s net sales amounted to SEK 0 (0) thousand. Operating expenses amounted to SEK 44,873 (101,743) thousand, a decrease of 56%. The Group’s loss after tax amounted to SEK 43,534 (93,389) thousand. The Group’s earnings per share before and after dilution amounted to SEK -1.16 (-2.96). Cash flow from operating activities amounted to SEK -47,342 (-65,129) thousand. Cash flow from financing activities amounted to SEK 47,329 (-425) thousand. Cash flow for the period amounted to SEK -12 (-65,186) thousand. SynAct Pharma AB announces that the number of shares and votes has increased by 5,725,484 as a result of the directed share issues resolved upon by the extraordinary general meeting on April 24, 2024. SynAct initiates filing process for Phase 2b ADVANCE study with resomelagon. For further information about SynAct Pharma AB, please contact: Jeppe ØvelsenCEO, SynAct Pharma AB Phone: +45 28 44 75 67 E-mail: joo@synactpharma.com Björn Westberg CFO, SynAct Pharma AB Phone: +46 703 33 91 23 E-mail: bwe@synactpharma.com About SynAct Pharma AB SynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For more information: www.synactpharma.com. This information is information that SynAct Pharma is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-20 07:30 CEST. Attachments SynAct Pharma Q2 2024 Interim Report

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