A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease

The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.

开始日期2022-09-02

申办/合作机构

Allena Pharmaceuticals, Inc.

NCT05168683 / Completed临床1期

A Phase 1, Single Centre, Two-Part, Open Label, Crossover Study in Healthy Volunteers Using Scintigraphy to Characterize the In Vivo Performance of ALLN-346 Enteric Coated Tablets

The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or other fed states.

开始日期2022-01-11

申办/合作机构

Allena Pharmaceuticals, Inc.

[+1]

NCT04987242 / Completed临床2期

An Inpatient, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects

The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting.

开始日期2021-07-16

申办/合作机构

Allena Pharmaceuticals, Inc.

100 项与 Allena Pharmaceuticals, Inc. 相关的临床结果

登录后查看更多信息

0 项与 Allena Pharmaceuticals, Inc. 相关的专利（医药）

登录后查看更多信息

项与 Allena Pharmaceuticals, Inc. 相关的文献（医药）

2022-06-28·NEJM evidence

Randomized Placebo-Controlled Trial of Reloxaliase in Enteric Hyperoxaluria

Article

作者: Kausz, Annamaria T. ; Lingeman, James E. ; Tosone, Christine ; Wyatt, Christina M. ; Knauf, Felix ; Lieske, John C. ; Ferraro, Pietro M.

BACKGROUND: Enteric hyperoxaluria is caused by increased intestinal oxalate absorption and can lead to kidney stones, chronic kidney disease, and kidney failure. Reloxaliase is an orally administered recombinant enzyme that degrades oxalate along the gastrointestinal tract, thereby preventing its absorption. METHODS: We randomly assigned participants with enteric hyperoxaluria to reloxaliase or placebo, three to five times per day with food for 4 weeks. The primary end point was percent change from baseline in 24-hour urinary oxalate (UOx) excretion during weeks 1 to 4. Secondary end points included the proportion of participants with more than a 20% reduction in 24-hour UOx and an efficacy assessment in the bariatric surgery subgroup. RESULTS: A total of 115 patients underwent randomization. The 24-hour UOx decreased from a baseline geometric mean of 83.2 to 67.4 mg/24 hr during weeks 1 to 4 in reloxaliase-treated participants. Corresponding data for placebo-treated participants were 84.2 to 78.1 mg/24 hr. Estimates from the mixed-effect model repeated-measures (MMRM) analysis showed a 22.6% reduction in geometric mean UOx during weeks 1 to 4 for reloxaliase and 9.7% for placebo, a difference of 14.3 percentage points (95% confidence interval [CI], 4.9 to 22.8; P=0.004). A 20% or greater reduction in 24-hour UOx was observed in 48.3% of reloxaliase-treated participants and 31.6% of placebo-treated participants (P=0.06). In the bariatric surgery subgroup, MMRM analysis showed a 21.2% reduction in geometric mean UOx for reloxaliase and a 6.0% reduction for placebo, for a difference of 16.2 percentage points (95% CI, 4.2% to 26.7%). Adverse events occurred in 69% of reloxaliase-treated participants versus 53% of individuals taking placebo and were most commonly gastrointestinal. All but one of the adverse events were grade 1 or 2 in severity; no reloxaliase-treated participants discontinued the study. CONCLUSIONS: Reloxaliase treatment for 4 weeks reduced UOx excretion in patients with enteric hyperoxaluria; adverse events were relatively common, but not dose-limiting. These data establish the foundation for a clinical trial to determine the impact of reloxaliase on nephrolithiasis in patients with enteric hyperoxaluria. (Funded by Allena Pharmaceuticals; ClinicalTrials.gov number, NCT03456830.)

2021-12-02·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2区 · 医学

Subsequent urinary stone events are predicted by the magnitude of urinary oxalate excretion in enteric hyperoxaluria

2区 · 医学

Article

作者: Kausz, Annamaria T ; Mehta, Ramila A ; Lieske, John C ; D’Costa, Matthew R ; Ingimarsson, Jóhann P ; Enders, Felicity T ; Carroll, Kevin J ; Mara, Kristin C

Abstract:

Data directly demonstrating the relationship between urinary oxalate (UOx) excretion and stone events in those with enteric hyperoxaluria (EH) are limited. Therefore, we assessed the relationship between UOx excretion and risk of kidney stone events in a retrospective population-based EH cohort. In all, 297 patients from Olmsted County, Minnesota were identified with EH based upon having a 24-h UOx ≥40 mg/24 h preceded by a diagnosis or procedure associated with malabsorption. Diagnostic codes and urologic procedures consistent with kidney stones during follow-up after baseline UOx were considered a new stone event. Logistic regression and accelerated failure time modeling were performed as a function of UOx excretion to predict the probability of new stone event and the annual rate of stone events, respectively, with adjustment for urine calcium and citrate. Mean ± standard deviation age was 51.4 ± 11.4 years and 68% were female. Median (interquartile range) UOx was 55.4 (46.6–73.0) mg/24 h and 81 patients had one or more stone event during a median follow-up time of 4.9 (2.8–7.8) years. Higher UOx was associated with a higher probability of developing a stone event (P < 0.01) and predicted an increased annual risk of kidney stones (P = 0.001). Estimates derived from these analyses suggest that a 20% decrease in UOx is associated with 25% reduction in the annual odds of a future stone event. Thus, these data demonstrate an association between baseline UOx and stone events in EH patients and highlight the potential benefit of strategies to reduce UOx in this patient group.

Background:

Data directly demonstrating the relationship between urinary oxalate (UOx) excretion and stone events in those with enteric hyperoxaluria (EH) are limited.

Methods:

We assessed the relationship between UOx excretion and risk of kidney stone events in a retrospective population-based EH cohort. In all, 297 patients from Olmsted County, Minnesota were identified with EH based upon having a 24-h UOx ≥40 mg/24 h preceded by a diagnosis or procedure associated with malabsorption. Diagnostic codes and urologic procedures consistent with kidney stones during follow-up after baseline UOx were considered a new stone event. Logistic regression and accelerated failure time modeling were performed as a function of UOx excretion to predict the probability of new stone event and the annual rate of stone events, respectively, with adjustment for urine calcium and citrate.

Results:

Mean ± SD age was 51.4 ± 11.4 years and 68% were female. Median (interquartile range) UOx was 55.4 (46.6–73.0) mg/24 h and 81 patients had ≥1 stone event during a median follow-up time of 4.9 (2.8–7.8) years. Higher UOx was associated with a higher probability of developing a stone event (P < 0.01) and predicted an increased annual risk of kidney stones (P = 0.001). Estimates derived from these analyses suggest that a 20% decrease in UOx is associated with 25% reduction in the annual odds of a future stone event.

Conclusions:

These data demonstrate an association between baseline UOx and stone events in EH patients and highlight the potential benefit of strategies to reduce UOx in this patient group.

2021-04-26·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2区 · 医学

Pilot study of reloxaliase in patients with severe enteric hyperoxaluria and hyperoxalemia

2区 · 医学

Letter

作者: Keddis, Mira T ; Kausz, Annamaria T ; Grujic, Danica ; Lieske, John C ; Pfau, Anja ; Knauf, Felix

The primary objective of the study was to determine whether reloxaliase can reduce POx and UOx over 12 wk of therapy.Reloxaliase is a recombinant oxalate decarboxylase enzyme from Bacillus subtilis expressed in Escherichia coli that catalyzes the conversion of oxalate to formate and carbon dioxide.

项与 Allena Pharmaceuticals, Inc. 相关的新闻（医药）

2024-06-12

·BioSpace

Alzheon Announces Appointment of Renowned Biopharma Executive Gino Santini to Board of Directors

Mr. Santini’s Extensive Global Commercial and Business Development Experience Strengthens Alzheon’s Board Leadership ALZ-801/Valiltramiprosate Has Potential to Become the First Oral Agent to Slow Alzheimer’s Pathology in Patients Fully Enrolled Pivotal APOLLOE4 Phase 3 Trial in Early Alzheimer’s Disease Patients on Track for Topline Data Readout and Initiation of NDA Submission in 2024 FRAMINGHAM, Mass.--(BUSINESS WIRE)-- Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has appointed Gino Santini to its Board of Directors. "2024 is a transformational year at Alzheon and with the anticipated readout of our APOLLOE4 Phase 3 trial, we are preparing for potential approval and commercialization of our pathbreaking product. Gino’s addition to our Board of Directors will help guide this broadening of our focus from running clinical trials to executing regulatory submissions and planning for commercial launch in number of territories,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon. “Alzheon’s well differentiated and simplified approach to disease modification has the potential to address crucial roadblocks in a market struggling to activate, and I look forward to strategic and business guidance from someone as experienced and accomplished as Gino.” Mr. Santini retired from a long and distinguished career at Eli Lilly in 2010. During his tenure at Eli Lilly, Mr. Santini held various leadership positions of increasing responsibility, including manager of various international regions, President of the Women’s Health Franchise and President of U.S. Operations. Mr. Santini capped his career at Eli Lilly as a member of the company’s executive committee and as Senior Vice President of Corporate Strategy and Business Development. Mr. Santini currently serves on the Boards of Directors of Intercept Pharmaceuticals and Collegium Pharmaceuticals. He previously served on the boards of SORIN SpA, Vitae Pharmaceuticals, Horizon Therapeutics, and AMAG Pharmaceuticals, until their acquisitions, and of Intarcia Therapeutics and Allena Pharmaceuticals. Mr. Santini is fluent in four languages and holds an undergraduate degree in mechanical engineering from the University of Bologna and an MBA from the University of Rochester. “Alzheon’s pioneering precision medicine and therapeutic approach has an opportunity to transform the standard of care and improve access to treatment for all Alzheimer’s patients, and it is an honor to be joining the Alzheon Board during this impactful period,” said Mr. Santini. “Bringing safe and effective therapies to the Alzheimer’s community is a noble mission and I could not be more excited about the prospects for Alzheon and the potential for ALZ-801 to fill a tremendous unmet medical need. APOLLOE4 Phase 3 trial evaluating oral ALZ-801 is expected to read out in the third quarter of 2024, and we are now preparing for a potential NDA submission this year followed by a commercial launch of the product in the U.S. in 2025.” About ALZ-801 ALZ-801/valiltramiprosate is a potential first-in-class, investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD.1,2,4,5 ALZ‑801 is designed to block the formation of neurotoxic soluble beta amyloid oligomers implicated in cognitive decline in Alzheimer’s patients.1,2,4 In mechanism of action studies, ALZ-801 has fully inhibited the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose.6,7 ALZ‑801 acts through a novel enveloping molecular mechanism of action to block formation of neurotoxic soluble amyloid oligomers in the human brain8 associated with the onset and progression of cognitive decline in AD patients.1,2,4 ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017 for Alzheimer’s disease. In clinical trials, ALZ-801 has shown potential for robust clinical efficacy and favorable safety results with no increased risk of brain vasogenic edema.6–8,10 The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), with potential future program expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.1–5 ALZ-801 Phase 2 Biomarker Trial Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease (NCT04693520): This ongoing trial was designed to evaluate the effects of 265 mg twice daily oral dose of ALZ-801 on biomarkers of AD pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotype and constitute 65-70% of Alzheimer's patients. The trial also included evaluation of clinical efficacy, safety, tolerability, and pharmacokinetic pro ALZ-801 over 104 weeks of treatment. An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 104 weeks of treatment for a total of 208 weeks. ALZ-801 APOLLOE4 Phase 3 Trial An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220): This ongoing trial is designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of ALZ-801 in Early AD subjects with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who constitute approximately 15% of Alzheimer's patients. This is a double-blind, randomized trial comparing oral ALZ-801 to placebo treatment over 78 weeks. The APOLLOE4 trial is supported by a $51 million grant from the National Institute on Aging. An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 52 weeks of treatment for a total of 130 weeks. About Alzheon Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of neurodegeneration. Our lead Alzheimer’s clinical candidate, ALZ-801/valiltramiprosate, is a first-in-class oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that has been observed to fully block the formation of neurotoxic soluble amyloid oligomers in preclinical tests. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients. Alzheon Scientific Publications 1 Tolar M, et al: The Single Toxin Origin of Alzheimer’s Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention, International Journal of Molecular Sciences, 2024; 25, 2727. 2 Tolar M, et al: Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression, International Journal of Molecular Sciences, 2021; 22, 6355. 3 Abushakra S, et al: APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease Show Accelerated Hippocampal Atrophy and Cortical Thinning that Correlates with Cognitive Decline, Alzheimer’s & Dementia, 2020; 6: e12117. 4 Tolar M, et al: Aducanumab, Gantenerumab, BAN2401, and ALZ-801—the First Wave of Amyloid-Targeting Drugs for Alzheimer’s Disease with Potential for Near Term Approval, Alzheimer’s Research & Therapy, 2020; 12: 95. 5 Tolar M, et al: The Path Forward in Alzheimer’s Disease Therapeutics: Reevaluating the Amyloid Cascade Hypothesis, Alzheimer’s & Dementia, 2019; 1-8. 6 Hey JA, et al: Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain, CNS Drugs, 2018; 32(9): 849-861. 7 Hey JA, et al: Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease, Clinical Pharmacokinetics, 2018; 57(3): 315–333. 8 Abushakra S, et al: Clinical Effects of Tramiprosate in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease Suggest Disease Modification Potential, Journal of Prevention of Alzheimer’s Disease, 2017; 4(3): 149-156. 9 Kocis P, et al: Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data, CNS Drugs, 2017; 31(6): 495-509. 10 Abushakra S, et al: Clinical Benefits of Tramiprosate in Alzheimer’s Disease Are Associated with Higher Number of APOE4 Alleles: The “APOE4 Gene-Dose Effect,” Journal of Prevention of Alzheimer’s Disease, 2016; 3(4): 219-228. View source version on businesswire.com: Contacts Source: Alzheon, Inc. View this news release online at:

临床3期高管变更临床2期快速通道

2024-04-25

·PRNewswire

Global Urine Output Monitoring Systems Market is Projected to Grow at a CAGR of ~5% by 2030 | DelveInsight

The increasing occurrence of kidney disorders worldwide and the healthcare sector's increased focus on consistent monitoring and effective management of these conditions are expected to drive the demand for urine output monitoring systems between 2024 and 2030. LAS VEGAS, April 25, 2024 /PRNewswire/ -- DelveInsight's Urine Output Monitoring Systems Market Insights report provides the current and forecast market analysis, individual leading urine output monitoring systems companies' market shares, challenges, urine output monitoring systems market drivers, barriers, trends, and key market urine output monitoring systems companies in the market. Key Takeaways from the Urine Output Monitoring Systems Market Report As per DelveInsight estimates, North America is anticipated to dominate the global Urine Output Monitoring Systems market during the forecast period. Notable urine output monitoring systems companies such as BD, Potrero Medical Inc., 3i Group plc, Serenno Medical, RenalSense Ltd., FIZE Medical, and several others, are currently operating in the urine output monitoring systems market. In February 2020, Serenno Medical introduced the Sentinel device for continuous automatic monitoring and detection of kidney damage in hospitalized patients. In August 2019, RenalSense received the CE Mark for its Clarity RMS, a critical care monitoring platform that constantly measures a patient's urine flow. To read more about the latest highlights related to the urine output monitoring systems market, get a snapshot of the key highlights entailed in the Global Urine Output Monitoring Systems Market Report Urine Output Monitoring Systems Overview Urine output monitoring systems play a crucial role in healthcare settings, offering real-time insights into a patient's renal function and overall health status. These systems typically employ advanced technology to accurately measure and record urine volume, allowing healthcare professionals to closely monitor fluid balance, kidney function, and response to treatment. By providing continuous, non-invasive monitoring, these systems aid in the early detection of potential complications such as dehydration, renal failure, or fluid overload, enabling timely interventions and improved patient outcomes. Furthermore, urine output monitoring systems streamline clinical workflows by automating data collection and analysis, reducing the burden on healthcare staff and minimizing the risk of human error. With customizable alerts and integrated data management capabilities, these systems empower healthcare teams to make informed decisions based on real-time urine output data, enhancing patient safety and optimizing resource utilization. In essence, urine output monitoring systems serve as invaluable tools in modern healthcare, facilitating proactive care management and ensuring patients receive the personalized attention they need. Urine Output Monitoring Systems Market Insights In 2023, North America dominated the urine output monitoring systems market due to various factors such as a growing number of individuals with kidney disorders, increased health awareness, rising disposable incomes, the presence of key industry players, and ongoing product development initiatives. These factors indicate a promising outlook for the urine output monitoring systems market in the region throughout the forecast period. According to the Centers for Disease Control and Prevention (CDC) in 2023, an estimated 35.5 million people, constituting more than 1 in 7 US adults, were believed to have chronic kidney disease (CKD) in 2021. Alarmingly, the CDC reported that as many as 9 out of 10 adults with CKD in the US were unaware of their condition, with approximately 1 in 3 adults having severe CKD being undiagnosed. Additionally, the increasing prevalence of diabetes, a significant risk factor for kidney disorders, further drives the demand for urine output monitoring systems in the United States. For instance, the CDC reported in 2021 that around 28.7 million people in the US were diagnosed with diabetes in 2019. Moreover, CDC data from 2022 revealed that approximately 96 million people in the US had prediabetic conditions in 2019, further underlining the importance of monitoring and managing kidney health in the region. To know more about why North America is leading the market growth in the urine output monitoring systems market, get a snapshot of the Urine Output Monitoring Systems Market Outlook Urine Output Monitoring Systems Market Dynamics The urine output monitoring systems market dynamics are witnessing significant evolution driven by several factors. With the rising prevalence of renal disorders, urinary tract infections, and chronic diseases, there's a growing demand for advanced monitoring systems to accurately measure and analyze urine output. Additionally, the increasing adoption of these systems in critical care settings, such as intensive care units (ICUs) and operating rooms, is fueling urine output monitoring systems market growth. Healthcare facilities are increasingly recognizing the importance of precise urine output monitoring in managing patient hydration levels, kidney function, and overall health outcomes. Furthermore, technological advancements play a crucial role in shaping the urine output monitoring systems market landscape. Innovations such as non-invasive monitoring techniques, integration of wireless connectivity for real-time data transmission, and the development of portable and wearable devices are enhancing the efficiency and usability of these systems. Moreover, the integration of artificial intelligence (AI) and machine learning algorithms into urine output monitoring platforms enables predictive analytics, early detection of abnormalities, and personalized patient care, driving market expansion and fostering a shift towards proactive healthcare management strategies. Moreover, regulatory initiatives and healthcare reforms are influencing urine output monitoring systems market dynamics by setting standards for product safety, performance, and interoperability. Compliance with stringent regulatory guidelines, such as those set forth by the FDA and other regulatory bodies, is imperative for manufacturers to ensure product quality and market acceptance. Additionally, reimbursement policies and incentives for healthcare providers investing in advanced monitoring technologies are shaping purchasing decisions and market penetration. As the healthcare landscape continues to evolve, urine output monitoring systems are poised to become indispensable tools for healthcare professionals in optimizing patient care and clinical outcomes. Get a sneak peek at the urine output monitoring systems market dynamics @ Urine Output Monitoring Systems Market Dynamics Analysis Urine Output Monitoring Systems Market Assessment Urine Output Monitoring Systems Market Segmentation Urine Output Monitoring Systems Market Segmentation By Product Type: Manual Urine Output Monitoring Systems and Automated Urine Output Monitoring Systems Urine Output Monitoring Systems Market Segmentation By Usage: Disposable and Reusable Urine Output Monitoring Systems Market Segmentation By End User: Hospital, Specialty Clinics, and Others Urine Output Monitoring Systems Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the urine output monitoring systems market are set to emerge as the trendsetter explore @ Urine Output Monitoring Systems Companies Table of Contents Interested in knowing the urine output monitoring systems market by 2030? Click to get a snapshot of the Urine Output Monitoring Systems Market Trends Related Reports Chronic Kidney Disease Market Chronic Kidney Disease Market Insight, Competitive Landscape, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key CKD companies, including ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc, Lexicon Pharmaceuticals, Sanofi, among others. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic kidney disease companies, including KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical, among others. Moderate and Severe Chronic Kidney Disease Market Moderate and Severe Chronic Kidney 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 moderate and severe chronic kidney disease companies, including Kibow Pharma, Bayer, Roche, Caladrius Biosciences, UnicoCell Biomed, Pharmicell, Scohia Pharma, Unicycive Therapeutics, among others. Moderate and Severe Chronic Kidney Disease Pipeline Moderate and Severe Chronic Kidney Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key moderate and severe chronic kidney disease companies, including Kibow Pharma, Bayer, Roche, Caladrius Biosciences, UnicoCell Biomed, Pharmicell, Scohia Pharma, Unicycive Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

2023-10-04

·BioSpace

KORU Medical Systems, Inc. Announces Appointment of Edward Wholihan to Its Board of Directors

MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced that Edward Wholihan was appointed to the Company's Board of Directors on September 28, 2023 to fill the vacancy that followed the Company's 2023 Annual Meeting of Shareholders. "I am extremely proud to welcome a highly accomplished executive such as Ed to our Board of Directors. He will be a valuable addition and we will benefit from his breadth of experience and success creating shareholder value in high-growth life science and healthcare businesses," said Linda Tharby, KORU Medical's President and CEO. "As we continue to build our leadership position in the subcutaneous infusion market with our FREEDOM Infusion System, Ed's insights will meaningfully contribute to our future growth and success." Edward Wholihan joins KORU Medical's Board of Directors with over 25 years of experience as Chief Financial Officer driving growth and shareholder value for public, private equity-sponsored, and venture capital-funded life sciences and healthcare businesses. Most recently, he has leveraged his strategic management, financial, and operational expertise consulting for various companies. Prior, he served as the Chief Financial Officer for Rarebreed Veterinary Partners, Inc, a community of veterinary hospitals; CFO of Allena Pharmaceuticals, Inc., a development stage biopharmaceutical company; and CFO of Medical Specialties Distributors, a leading solution provider to the specialty pharmacy, home infusion, and oncology practice markets that was acquired by McKesson Corp (NYSE:MCK) in 2018. Ed also held two other CFO roles within the life science sector earlier in his career and, prior to that, spent seven years as a management strategy consultant for McKinsey & Company. He earned his MBA from Stanford University's Graduate School of Business and a BA in economics from Yale University. "I am impressed with KORU Medical's tremendous progress, innovation, and commitment toward growth, and I am excited to take part in helping the Company achieve its goal of improving the quality of life for patients around the world," said Mr. Wholihan. "I look forward to supporting Linda and the KORU Medical team as they continue to drive the Company’s growth strategy and the provision of subcutaneous infusion therapies and their benefits to patients." About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients around the world. The FREEDOM™ Infusion System currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit .

高管变更并购

100 项与 Allena Pharmaceuticals, Inc. 相关的药物交易

登录后查看更多信息

100 项与 Allena Pharmaceuticals, Inc. 相关的转化医学

登录后查看更多信息