April 3, 2023 – Boston, MA : Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company, announces that the National Institute of Neurological Disorders and Stroke (NINDS)- National Institutes of Health (NIH) have awarded the Preclinical Screening Pain Platform (PSPP) award to Aisa’s Profervia® (cilnidipine), a once-daily novel, investigational, oral calcium-channel antagonist. The PSPP was created as part of the Helping End Addiction Long-Term (HEAL) initiative to help develop non-opioid analgesics.
Cilnidipine is approved in select Asian countries to treat hypertension and has a 28-year established safety profile. Aisa Pharma is evaluating Profervia® in a Phase 2 clinical program in patients with Systemic Sclerosis and secondary Raynaud’s phenomenon (SSc-RP), a painful vasoconstrictive disorder.
The Federal Pain Research Strategy identified an urgent need to reduce reliance on prescription opioid medications through the development of new, non-opioid treatments for pain. The NIH HEAL Initiative was designed to accelerate the development of new drugs for this need. Over 25 million Americans have chronic pain and take opioids for pain control.
“We are thrilled that the NIH will investigate Profervia®’s analgesic effects in multiple validated pain models,” said Andrew Sternlicht, M.D., CEO and Founder of Aisa Pharma. “Early data from our current Phase 2 study in SSc-RP patients reported impressive reductions in pain versus placebo.”
The PSPP program will assess Profervia® in in-vitro assays and preclinical animal models of human pain conditions. It will assess pharmacokinetics, safety, and efficacy. The work is performed at the NIH-NINDS, with rights retained by Aisa Pharma.
About Profervia®:
Profervia® is a novel form of cilnidipine, a fourth-generation calcium channel blocker(CCB). Cilnidipine is approved in select Asian countries for hypertension with decades of safety data. Cilnidipine increases blood flow to peripheral tissues and further improves function in the heart, kidney and vasculature. Cardiac, renal and vascular disease contribute to morbidity and mortality in patients with SSc. Thus, cilnidipine may improve SSc-RP, and the underlying disease. In robust studies of hypertension treatment, cilnidipine was better tolerated than US-approved CCBs, which are used off-label for Raynaud’s. Unlike other approved CCBs, cilnidipine also targets receptors that have a role in certain painful conditions.
About Aisa Pharma Inc.
Aisa is a privately funded biopharmaceutical company in Boston, MA. Aisa is developing Profervia® for use in patients with SSc-RP.
For additional or investor information: IR@aisapharma.com or https://www.aisapharma.com