CARY, North Carolina, October 5, 2022 /PRNewswire/ — BioLink Life Sciences Cary, North Carolinaannounced today that it has received a contract from BARDA (the Biomedical Advanced Research and Development Authority) to fund the development of Ramatroban for the treatment of patients hospitalized with COVID-19 pneumonia (the RAMBAN-1 study).
BioLink’s $750,000 BARDA’s contract complements a multi-million dollar grant from Open Philanthropy to the Charak Foundation. RAMBAN-1 is a randomized, placebo-controlled Phase 2/3 clinical trial to evaluate the safety and efficacy of Ramatroban in accelerating the recovery of hospitalized patients with COVID-19 pneumonia with 28 days of treatment. RAMBAN-1 will also explore whether treating acute illness for 28 days with Ramatroban reduces the risk of subsequent development of post-acute sequelae of COVID-19 (“long COVID”) over the following 11 months.
This study, which will be conducted at multiple clinical sites in Indiashould support emergency use authorization by regulatory authorities in India for acute COVID-19 while laying the groundwork for future clinical trials treating both acute COVID and the long United States.
Ramatroban has been approved and used in Japan for more than 20 years for the twice-daily oral treatment of allergic rhinitis. 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 blood circulation in the lungs, reduces blood oxygenation and promotes blood clotting while prostaglandin D2 leads to immune system misfires.
In a breakthrough case series, the use of ramatroban led to rapid and sustained relief of 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 recently been reviewed (Chiang et al2022).
Ajay Gupta MD, Chief Medical Officer of KARE Biosciences and Head of the Charak Foundation said, “We welcome the initiative of Open Philanthropy and BARDA to support the development of therapeutic agents for the COVID-19 pandemic, agents that target disease development for both COVID-19 and perpetrators of future pandemics. Lipid mediators have been overlooked as therapeutic targets in COVID-19 and many other diseases. Ramatroban is the only known dual receptor thromboxane A antagonist2 and DPI2 stock. We hope to exploit the great potential of this drug for the treatment of respiratory, neurological, cardiovascular, immunological and other manifestations of SARS-CoV-2 and other infectious pathogens. »
Deanna Nelson PhD, President of BioLink, said, “We are very pleased to repurpose a drug that has an established safety record over 20 years of use, which is given twice daily orally to inpatients and outpatients and which is very profitable. If the therapeutic benefits of Ramatroban are successfully demonstrated, the RAMBAN-1 study will serve as a springboard for the application of this unique drug to treat both COVID-19 and many similar diseases that are characterized by a “storm” of thromboxane-prostaglandin and platelet activation leading to thrombo-inflammation in conjunction with a dysregulated immune response.”
About Ramatroban: Ramatroban, a dual thromboxane and prostanoid receptor blocker, has demonstrated efficacy in animal models of respiratory dysfunction, atherosclerosis, thrombosis, and sepsis, and preliminary evidence of rapid relief of dyspnea and of 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 clinical research company that develops new proprietary pharmaceutical products through multiple regulatory pathways. Its patented product portfolio includes a range of supplements for general wellness and bone health, as well as late-stage medicines targeting significant unmet medical needs in kidney and skeletal health.
About the Charak Foundation:
The Charak Foundation is a Southern California-private non-profit foundation of Dr. Ajay Gupta. The foundation is dedicated to promoting the health and education of the underprivileged and to medical research, with an emphasis on diseases that disproportionately affect populations in developing or low-income countries.
About KARE Biosciences:
KARE Biosciences is a Orange County, Californiais a Geneva-based biotechnology company dedicated to drug reuse and the discovery of new small molecules to address unmet needs in various medical fields, including rare diseases. The Company is currently developing Ramatroban as a treatment for acute and prolonged COVID-19, thrombotic disorders, silicosis, sickle cell disease, pulmonary hypertension and other disorders. KARE Biosciences is also developing a new antihypertensive combination of indapamide, the best thiazide-type 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 funded this project as part of a portfolio of grants to prioritize causes based on three criteria: significance, neglect, and traceability. This project was funded in whole or in part by 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.
SOURCEBioLink Life Sciences