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

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. "We will continue to validate the biologic and scientific rationale and impact of treatment on overall disease course in SSc. Almost all SSc patients suffer from Raynaud's and new treatments are urgently needed given the high morbidity and burden of the disease."

About Profervia^®:

Profervia^® is a novel form of cilnidipine, a fourth-generation calcium channel blocker (CCB). Cilnidipine is an approved and popular option to treat hypertension in select Asian countries. Cilnidipine causes vasodilation and 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 hypertension studies, cilnidipine is better tolerated with a wider therapeutic window than US-approved CCBs used off-label for Raynaud's. Unlike other approved CCBs, cilnidipine further may have a role in certain painful conditions. 

About Aisa Pharma Inc.

Aisa is a private biopharmaceutical company in Boston, MA. Aisa is developing Profervia^® for use in patients with SSc-RP.

For additional information: [email protected]; http://www.aisapharma.com

SOURCE Aisa Pharma