AISA Pharma Announces Completion of Enrollment in Phase 2 RECONNOITER Trial of AISA-021 in Systemic Sclerosis-Related Raynaud's Phenomenon

Results from Phase 2 RECONNOITER trial accepted as oral presentation at World Systemic Sclerosis Conference in Athens, Greece March 5-7, 2026

Dr. Norman Stockbridge, Former FDA Division Director, to consult for AISA on Phase 3 design and regulatory strategy

BOSTON, Dec. 2, 2025 /PRNewswire/ -- Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company announced the completion of enrollment in the RECONNOITER Phase 2 trial of AISA-021 (cilnidipine), a fourth-generation calcium channel antagonist for the treatment of Systemic Sclerosis-associated Raynaud's Phenomenon. The RECONNOITER study enrolled 63 patients in two parts, initially evaluating dose, efficacy and safety, followed by a double-blind, prospective, randomized crossover study. Aisa is developing AISA-021 for the treatment of Raynaud's in Systemic Sclerosis (SSc), and Systemic Sclerosis itself, which is a rare disease affecting 100,000 Americans with the highest mortality of any autoimmune disease.

Raynaud's, most commonly presents as recurrent painful attacks of digital ischemia in the fingers or toes. In addition to SSc, it is a symptom of other diseases including lupus and rheumatoid arthritis and is estimated to impact up to 5% of the world's population. Although Raynaud's has been regarded as a nuisance affliction, recent studies highlight that it is associated with a an approximately 25-30% increase in cardiovascular and thromboembolic disease compared to the general population, especially among younger patients.

"We are delighted to complete the study and thank the entire team at Flinders Medical University in Australia for their continued efforts as we assessed AISA-021 in patients who are desperately seeking new treatments for their Raynaud's," said Andrew Sternlicht, MD, CEO and Founder of Aisa Pharma. "We eagerly await the unblinding of the trial and full data analysis in February 2026. Aisa Pharma is actively seeking a development partner and investors to support bringing this much-needed treatment to patients."

Aisa also announced today key corporate and scientific progress:

• RECONNOITER Phase 2 results were accepted for an oral presentation at the World Congress on Systemic Sclerosis, which will be held March 5-7, 2026 in Athens, Greece, The data will be presented by Prof. Francesco Del Galdo, MD, PhD, the past President of EUSTAR, the European Scleroderma Clinical Trials and Research Group.
• Dr. Norman Stockbridge, of S & S Consulting, who led the FDA Division of Cardiology and Nephrology for 20 years, as well as AISA's pre-IND meeting with the Division, will be consulting with Aisa Pharma on an ongoing basis as we pursue a Phase 3 trial and U.S. regulatory approval for the treatment of patients with Systemic Sclerosis-associated Raynaud's Phenomenon.
• Aisa has developed a proprietary new synthetic process for the manufacturing of cilnidipine that yields ultra-high purity drug substance and is developing several new proprietary drug products for cilnidipine.
• Aisa's patent for the treatment of Raynaud's and Systemic Sclerosis with AISA-021 and other drugs has issued in the EU, has received notice of allowance from Canada, and is in final review with the U.S. patent office.
• AISA-021 has demonstrated significant analgesic effects in preclinical post-operative pain studies conducted by the National Institutes of Health (NIH) as part of its Preclinical Pain Screening Platform. Additional results in other models are pending.

About AISA-021
AISA-021 is a form of cilnidipine, a fourth-generation calcium channel blocker (CCB), distinguished from other dihydropyridine CCBs by its increased selectivity for the N-type calcium channel. Cilnidipine is approved in certain Asian countries and used to treat hypertension, but was never approved in the U.S., Canada, EU or UK. Cilnidipine causes vasodilation and further improves function in the heart, kidney and vasculature. In robust studies of hypertension treatment, cilnidipine is better tolerated with a wider therapeutic window than other CCBs, which are used off-label to treat Raynaud's. Aisa Pharma has manufactured a new form of cilnidipine and is preparing a final drug product designed to specifically treat Raynaud's phenomenon. Unlike other approved CCBs, AISA-021 may also have a role in treating pain. AISA-021 has received Orphan Drug Designation from the U.S. FDA for Treatment of Systemic Sclerosis. Aisa is applying for Orphan Designation in other geographies.

About Systemic Sclerosis and Raynaud's Phenomenon in Systemic Sclerosis
Systemic Sclerosis (SSc) is the most fatal of autoimmune illnesses and affects approximately 100,000 patients in the United States. Approximately half die of the disease within 12 years from diagnosis and 95% of SSc patients experience Raynaud's symptoms, which they describe as their most debilitating symptom. Raynaud's Phenomenon is characterized by decreased blood flow which can cause severe pain and tingling in the hands and fingers. Cardiac, renal and vascular disease, which have been shown to improve in patients treated for hypertension with Cilnidipine, contribute to morbidity and mortality in patients with SSc. No oral drug has been approved anywhere in the world for the treatment of Raynaud's.

About Aisa Pharma Inc.
Aisa is a private biopharmaceutical company in Boston, MA, founded in 2019. For additional information: [email protected]; http://www.aisapharma.com

SOURCE Aisa Pharma