#USA #Boston #Aisa Pharma #AISA-021 #Raynaud's Phenomenon

AISA Pharma Completes Enrollment for Phase 2 RECONNOITER Trial of AISA-021

Aisa Pharma, Inc., a Boston-based biopharmaceutical company, has recently announced the successful completion of patient enrollment in its pivotal Phase 2 trial known as RECONNOITER. This trial investigates AISA-021, a new treatment designed specifically for Raynaud's Phenomenon associated with systemic sclerosis (SSc). This debilitating condition and its associated symptoms severely stall patients' daily lives, demanding new treatment options.

Background on Raynaud's Phenomenon and Systemic Sclerosis

Raynaud's Phenomenon manifests as episodes of reduced blood flow, leading to painful attacks, often impacting the fingers and toes. While commonly seen in patients with systemic sclerosis, those suffering from lupus or rheumatoid arthritis can also experience symptoms. The condition is more prevalent than many realize, estimated to affect up to 5% of the global population. Notably, while Raynaud's was previously considered merely a nuisance, emerging research indicates it significantly increases risks for cardiovascular and thromboembolic diseases, especially in younger patients.

In the U.S., approximately 100,000 individuals live with systemic sclerosis, characterized by a high mortality rate among autoimmune diseases—up to 50% may die within 12 years of diagnosis. With 95% of SSc patients experiencing Raynaud's symptoms, this issue needs urgent attention in medical research.

The RECONNOITER Trial

The RECONNOITER study encapsulates an important step towards finding effective treatments for SSc-related Raynaud's. It enrolled 63 participants and consists of two components: an initial evaluation of dosing, efficacy, and safety, followed by a rigorously structured double-blind crossover study. Such a design is crucial in thoroughly assessing AISA-021's therapeutic potential.

Dr. Andrew Sternlicht, CEO and Founder of Aisa Pharma, expressed gratitude to patients and the team at Flinders Medical University in Australia who contributed significantly to the trial. "We eagerly await the unblinding of the trial and full data analysis in February 2026," Sternlicht said, underlining the importance of the trial's outcomes.

The Role of AISA-021

AISA-021, a proprietary formulation of cilnidipine, is noteworthy not only as a fourth-generation calcium channel antagonist but also for offering pain relief beyond its primary function. Unlike traditional calcium channel blockers currently used to treat Raynaud’s, AISA-021 uniquely targets the N-type calcium channel with notably higher selectivity. This highlights its considerable scope of action and improved tolerance compared to other available treatments. It has already received Orphan Drug Designation from the FDA, indicating its potential as a critical therapeutic option for sufferers of systemic sclerosis.

Future Directions and Regulatory Consultation

Aisa Pharma’s progress doesn’t end with the trial's completion. The RECONNOITER Phase 2 results have been accepted for an oral presentation at the forthcoming World Congress on Systemic Sclerosis scheduled for March 2026 in Athens, Greece, a pivotal platform to share findings with the global medical community. Additionally, Aisa has engaged Dr. Norman Stockbridge, a seasoned expert from S Consulting, to guide them through the preparation for Phase 3 trials and subsequent U.S. regulatory procedures.

With plans underway to find strategic partnerships and secure funding to expedite the development of this urgently needed treatment, Aisa Pharma is positioned at the forefront of innovative research, not just for Raynaud’s but also the broader implications for systemic sclerosis.

As Aisa Pharma continues to leverage cutting-edge science and clinical research, the forthcoming analyses and results may mark significant milestones in combating one of the most challenging autoimmune disorders faced today. The community holds its breath for new hope in AISA-021 and its potential to transform the lives of countless patients living with the harsh realities of systemic sclerosis.