BioLink Life Sciences, Charak Foundation and KARE Biosciences Announce contract for developing a novel treatment of COVID pneumonia and prevention of long COVID

2022-10-05

合作小分子药物紧急使用授权

CARY, N.C., Oct. 5, 2022 /PRNewswire/ -- BioLink Life Sciences of Cary, North Carolina, today announced receiving a contract from BARDA (the Biomedical Advanced Research and Development Authority) to fund the development of Ramatroban for treatment of patients hospitalized with COVID-19 pneumonia (the RAMBAN-1 Study).

BioLink's $750,000 contract from BARDA complements a multimillion dollar grant from Open Philanthropy to the Charak Foundation. RAMBAN-1 is a Phase 2/3 randomized, placebo-controlled clinical trial to evaluate Ramatroban's safety and efficacy in speeding recovery in hospitalized patients with COVID-19 pneumonia with a 28-day course of treatment. RAMBAN-1 will also explore if the 28-day treatment of acute disease with Ramatroban reduces the risks of subsequent development of post-acute sequelae of COVID-19 ("long COVID") over the ensuing 11 months.

This study, which will be carried out at multiple clinical sites in India, is expected to support an emergency use authorization by regulatory authorities in India for acute COVID-19 while laying the groundwork for future clinical trials treating both acute and long COVID in the United States.

Ramatroban has been approved and used in Japan for over 20 years for treatment of allergic rhinitis by twice daily oral administration. In COVID-19 ramatroban targets pathways activated by massive increases in lipid mediators including thromboxane A2 and prostaglandin D2. Clinical investigators believe that thromboxane A2 slows the blood circulation through the lungs, reduces oxygenation of blood, and promotes blood clotting while prostaglandin D2 leads to misfiring of the immune system.

In a ground-breaking case series, ramatroban use led to rapid and sustained relief of both acute respiratory distress and hypoxemia in outpatients with COVID-19 pneumonia, thereby avoiding hospitalization (Ogletree et al. 2022). The potential mechanism of action of ramatroban in COVID-19 has been reviewed recently (Chiang et al, 2022).

Ajay Gupta MD, Chief Medical Officer of KARE Biosciences and head of the Charak Foundation stated, "We welcome the initiative by Open Philanthropy and BARDA to support development of therapeutic agents for the COVID-19 pandemic, agents that target disease development both for COVID-19 and perpetrators of future pandemics. Lipid mediators have been ignored as therapeutic targets in COVID-19 and many other diseases. Ramatroban is the only known dual receptor antagonist of both thromboxane A2 and PGD2 action. We hope to exploit the great potential of this drug for treatment of respiratory, neurological, cardiovascular, immunologic and other manifestations of SARS-CoV-2 and other infectious pathogens."

Deanna Nelson PhD, President of BioLink stated, "We are very excited to repurpose a drug that has an established safety record over 20 years of use, is conveniently given twice daily by mouth to both inpatients and outpatients and is highly cost effective. If therapeutic benefits of Ramatroban are demonstrated successfully, the RAMBAN-1 study will serve as a springboard for application of this unique drug to treat both COVID-19 and many similar disease conditions that are characterized by a thromboxane-prostaglandin "storm" and platelet activation leading to thrombo-inflammation in conjunction with a dysregulated immune response."

About Ramatroban: Ramatroban, a dual blocker of thromboxane and prostanoid receptors, has demonstrated efficacy in animal models of respiratory dysfunction, atherosclerosis, thrombosis, and sepsis, and preliminary evidence for rapid relief of dyspnea and hypoxemia in COVID-19 pneumonia. Ramatroban merits investigation as a promising antithrombotic and immunomodulatory agent for prophylaxis and treatment.

About BioLink Life Sciences:

BioLink Life Sciences is a North Carolina based clinical research company that develops novel, proprietary pharmaceutical products via multiple regulatory pathways. Its portfolio of patented products includes a line of supplements for general wellbeing and bone health, as well as late-stage drugs targeting large, unmet medical needs in renal and skeletal health.

About Charak Foundation:

Charak Foundation is a Southern California-based, privately operating, nonprofit foundation of Dr. Ajay Gupta. The foundation is dedicated to promoting health and education for the underprivileged and conducting medical research, with a focus on diseases that disproportionately affect the populations of developing or low-income countries.

About KARE Biosciences:

KARE Biosciences is an Orange County, California-based biotechnology company dedicated to repurposing drugs and discovering new small molecules to address unmet needs in a variety of medical areas, including rare diseases. The company is currently developing Ramatroban as a treatment for acute and long COVID-19, thrombotic disorders, silicosis, sickle cell disease, pulmonary hypertension, and other disorders. KARE Biosciences is also developing a novel, antihypertensive combination of indapamide, the best-in-class thiazide-like diuretic, in combination with a mineralocorticoid receptor antagonist (spironolactone or eplerenone). These combinations were patented by the Company in 2010.

About Open Philanthropy and BARDA funding:

Open Philanthropy has funded this project as one of a portfolio of grants in support of causes that are prioritized based on three criteria: importance, neglectedness, and tractability. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50122C00068.

SOURCE BioLink Life Sciences