AISA Pharma Announces Start of Phase 2b Profervia® Study for Raynaud’s Phenomenon in Systemic Sclerosis (SSc)

Phase 2 Data at EULAR Suggested Profervia^® Treatment Might Influence Systemic Sclerosis (SSc) Disease Severity

Excerpt from the Press Release:

BOSTON, June 21, 2023 /PRNewswire/ — Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company today announced initiation of Part 2 of the RECONNOITER Phase 2 study, evaluating Profervia^®, a once-daily novel, oral calcium-channel antagonist (CCB) in patients with SSc and Raynaud’s phenomenon(SSc-RP). The study is a double-blind, placebo-controlled, randomized, prospective crossover study design which will take approximately 10 months to complete.

Aisa also announced the company presented initial positive safety and efficacy data from the Phase 2a RECONNOITER study at EULAR 2023 in Milan, Italy. Incidence and type of adverse events reported in the first 27 patients of the study were compared with a large metanalysis of current CCBs. Patients had a 17% incidence of AEs with Profervia^® compared to 43% with current CCBs (p=0.025). Profervia^® also had a greater effect on Raynaud’s attack frequency (-43% versus -24% with current CCBs) and reduced SSc disease severity compared with placebo on a validated patient-reported outcome questionnaire (SHAQ) (p=0.01.) 

“We are excited to move forward with the second part of our Phase 2 study, and encouraged by the data presented at EULAR, which demonstrated that Profervia^® may provide significant relief to patients with SSc-RP,” said Andrew Sternlicht, MD, CEO and Founder of Aisa Pharma.

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