AISA Pharma Announces Positive Data Safety Monitoring Board Review of First Phase 2 Data of Profervia® to treat Raynaud’s Disease in Scleroderma Patients
Company to Move Forward with Key U.S. Regulatory Applications – Investigational New Drug and Orphan Drug Designation
BOSTON, July 26, 2022 (GLOBE NEWSWIRE) — Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist has met and unanimously recommended continuing to the next stage in the trial and approved a go-forward dose level. In addition, the DSMB found no safety issues of concern and encouraging early efficacy trends in this first-ever clinical trial of the drug in the Phase 2 dose-finding portion of the study of patients with secondary Raynaud’s disease associated with scleroderma. The company will now begin Part B, a double-blind, prospective, placebo-controlled, randomized crossover study, which will randomize additional patients.
Scleroderma is the most fatal of the autoimmune diseases and 95% of patients experience Raynaud’s symptoms, which are debilitating, painful attacks commonly felt in the fingers that may occur multiple times daily and greatly diminish patients’ quality of life. Aisa’s study is examining whether its proprietary therapy can reduce the frequency, severity, and duration of these attacks, modify the course of the disease, and improve other symptoms of Scleroderma.
Based on the DSMB recommendation, the Phase 2 study will continue from the first dose-finding portion (Part A) into its second double blind randomized crossover stage (Part B) with the selected Profervia® dose. The DSMB reviewed data by treatment group assignment and concluded that no safety issues of concern were demonstrated in the first 27 patients. The DSMB remarked that the treatment appeared to be much better tolerated than their own and published clinical trial experience of currently used calcium channel blocker therapy for treating Raynaud’s in Scleroderma patients, The DSMB also accelerated the study, recommending that the study had met its goals for the Part A dose-finding parallel group assignment first phase and that the study proceed directly into the double-blind crossover Part B of the study, recalculating the sample size based on the treatment effect seen and omitting an additional 9 patients originally planned for Part A.
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