AISA Pharma Announces Initiation of Patient Enrollment in Phase 2 Trial of Novel Therapy for Raynaud’s Disease in Scleroderma
June 16, 2021 – Boston, MA : Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, announces that it has begun enrolling patients in a Phase 2 study evaluating the novel investigational therapy Profervia® in patients with secondary Raynaud’s disease associated with scleroderma. The double-blind, prospective, placebo-controlled, randomized crossover study will randomize 76 patients and is being conducted in Australia.
Raynaud’s disease is an abnormal constriction of the blood vessels in the hands and extremities in response to cold or other stimuli. Patients experience feelings of numbness, severe aching or pain, tingling or throbbing, a sensation of tightness, and/or a loss of sensation. Raynaud’s disease can result from a primary disease, or as a result of certain medications, surgery or nerve injury. Although prevalence is estimated at 5-6% of the population, most patients don’t know they have the condition. Scleroderma is a serious, rare autoimmune disease with 10-year mortality approaching 35%; the vast majority of scleroderma patients have Raynaud’s and it is often the presenting symptom.
“To date, there is no Food and Drug Administration approved treatment specifically for Raynaud’s disease, which affects as many as 27 million Americans,” said Andrew Sternlicht, MD, CEO and Founder of Aisa Pharma. “We hope that our treatment may offer hope to the many patients with this condition who often have difficulty carrying out their normal activities, particularly during the winter months. Although there have been many efforts to advance treatments for Raynaud’s, they have been largely unsuccessful to date. Aisa is taking a novel approach, leveraging a proprietary drug combination, which maximizes the potency of two well-established classes of medicine with demonstrated safety and efficacy in this population.”
Profervia® is a combination of Cilnidipine, a novel calcium channel blocker (CCB) approved in several countries outside the U.S. and Tadalafil (marketed as Cialis®), a phosphodiesterase (PDE) inhibitor used throughout the world for erectile dysfunction. Both cilnidipine and tadalafil increase blood flow to peripheral organs and tissues. CCBs and PDE inhibitors are used to treat patients with scleroderma and Raynaud’s symptoms alone and in combination; however, cilnidipine, which has a unique efficacy and tolerability profile, has never been tested alone or in combination with a PDE inhibitor in these diseases.
Sternlicht continued, “Our panel of expert physicians who treat and conduct research for scleroderma patients are excited about our program and suggest that the benefits of the treatment may well extend beyond improvement of Raynaud symptoms into underlying disease pathological contributors. Jerry Molitor, MD, PhD, Associate Professor of Medicine and Rheumatology and Director of the Scleroderma Clinic at the University of Minnesota said “Aisa’s approach, utilizing the specific type of calcium channel blocker they are employing in combination with the blood vessel-dilating phosphodiesterase inhibitor, makes perfect sense and its well-documented and published benefits could contribute important advances for our scleroderma patients.”
Aisa expects first data from the study, knows as RECONNOITER, later this year and plans to file an Investigational New Drug application (IND) with the FDA to begin a U.S. multi-center study of in the fourth quarter of 2021. Aisa also plans to apply for orphan drug designation from the FDA for treatment of secondary Raynaud’s disease in scleroderma.
About Aisa Pharma Inc.
Aisa is a privately-funded biopharmaceutical company located in Boston, MA. Aisa’s initial therapeutic under development is Profervia®, intended for use in patients with Raynaud symptoms with scleroderma.
For questions regarding the trial, Profervia, or investment in Aisa Pharma, please contact us.