Aisa Pharma to Present New Data from the Phase 2 RECONNOITER-1 Trial in Systemic Sclerosis-Associated Raynaud's Phenomenon at ACR Convergence 2026
- AISA-021 significantly reduced median weekly Raynaud's attack frequency and duration while increasing the number of attack-free days in the Phase 2 RECONNOITER-1 clinical trial
- AISA-021 was well-tolerated, with a safety profile comparable to placebo
- Plasma concentration correlated strongly with reductions in Raynaud's attack frequency and overall disease burden
- The Company is preparing to initiate a global Phase 3 pivotal study and has submitted a Type C meeting request to the U.S. Food and Drug Administration (FDA) to review its development strategy and potential registration pathway
BOSTON, Nov. 9, 2026 /PRNewswire/ -- Aisa Pharma, Inc., a clinical-stage biopharmaceutical company focused on therapies for systemic sclerosis, today announced additional data from its Phase 2 RECONNOITER trial of AISA-021 (cilnidipine), a novel once-daily dual calcium channel antagonist, for the treatment of systemic sclerosis-associated Raynaud's phenomenon (SSc RP). The data will be presented in an oral presentation at the American College of Rheumatology (ACR) Convergence 2026, being held in Orlando, Florida from November 6-11, 2026. The presentation will be delivered by Professor Francesco Del Galdo, the Head of the Scleroderma Program at Leeds University in the United Kingdom. Initial results from the study were first presented at the World Systemic Sclerosis Congress held in Athens, Greece, in March 2026.
"Systemic sclerosis-associated Raynaud's phenomenon is one of the most debilitating complications of scleroderma, yet patients still lack an FDA-approved treatment option," said Andrew Sternlicht, M.D., Founder and Chief Executive Officer of Aisa Pharma. "The Phase 2 RECONNOITER-1 data demonstrate the potential of AISA-021 to meaningfully reduce both the frequency and burden of Raynaud's attacks. In addition to achieving a statistically significant reduction in weekly attack frequency, AISA-021 delivered improvements in attack-free days and attack duration, underscoring the potential for a broad clinical benefit. We believe these results, together with the favorable safety and tolerability profile observed to date, support continued development of AISA-021 and provide a strong foundation as we prepare for a global Phase 3 pivotal trial and engage with the FDA on a regulatory pathway toward registration."
Professor Del Galdo added, "The RECONNOITER-1 trial is unique and particularly noteworthy in that it evaluated AISA-021 as an add-on therapy in patients with advanced systemic sclerosis-associated Raynaud's phenomenon, in a population with a median disease duration of nearly 15 years and substantial prior treatment exposure. More than 70% of patients were receiving active therapy for their Raynaud's phenomenon, with medications optimized before entering the study. In this difficult-to-treat population, AISA-021 demonstrated clinically meaningful improvements across multiple measures of disease burden while maintaining a safety profile comparable to placebo. These results support a favorable benefit-risk profile and underscore the potential of AISA-021 to address a significant unmet need for patients living with SSc-RP. Importantly, many patients who responded to AISA-021 had previously experienced inadequate efficacy or poor tolerability with conventional calcium channel blockers, highlighting the difference of AISA-021 compared to these agents, and the drug's potential to provide meaningful clinical benefit in patients with limited treatment options."
The Phase 2 RECONNOITER clinical trial (ACTRN12621000459820) was a randomized, double-blind, placebo-controlled, prospective, crossover study evaluating AISA-021, a once-daily oral therapy, in patients with active SSc RP. The study enrolled a total of 64 patients and was conducted in two parts. The new data being presented at ACR Convergence 2026 are from Part B, a randomized crossover study designed to evaluate safety and efficacy in 37 patients. The primary endpoint was the change from baseline in the mean weekly number of Raynaud's attacks recorded, with key secondary endpoints including severity, duration, Raynaud's condition score (RCS), pain, and attack-free days. Patients were treated with standard of care therapies and AISA-021 was added on to their existing medication regimen.
Additional data from the RECONNOITER study demonstrated the following:
- On the endpoint of reduction in Raynaud's attacks characterized by color change and localized symptoms of numbness, tingling, or pain, patients treated with AISA-021 achieved a 43% reduction in the mean frequency of Raynaud's attacks compared to baseline, while placebo-treated patients had a 26% reduction (p = 0.028)
- AISA-021 significantly increased the proportion of attack‑free days, resulting in a more than 155% placebo‑adjusted improvement and nearly a four‑fold increase from baseline (p = 0.013)
- In the first treatment sequence, patients receiving AISA-021 demonstrated a 41.7% reduction in attacks frequency, compared with a 14.2% reduction with placebo (p=0.028), supporting a robust treatment effect prior to any potential carryover effects with direct implication for the likelihood of success in the planned Phase 3 trial which is designed as a parallel-arm randomized, double-blind, prospective, placebo controlled study.
- AISA-021 significantly reduced the duration of Raynaud's attacks (p=0.02) and improved thermographic assessment of skin temperature measured at the proximal interphalangeal joint (PIP) level (p=0.047)
- AISA-021 demonstrated a strong trend toward improvement in scleroderma-related pain, with a 42% reduction from baseline, compared with a 15% reduction in the placebo cohort (p=0.07)
- Treatment effects were greater in patients with more recent disease diagnosis (less than 7 years from diagnosis (n=6)), 5.5 fewer attacks were seen (p=0.05) and in patients with Limited disease (versus Diffuse disease) (n=23), (p=0.02)
- While plasma drug concentration was found to be quite variable (>10x) in patients (n=24), consistent with previous observations, the relationship between patients in the top half, versus lower half of modeled concentration and efficacy was clearly demonstrated on a validated PRO measure (ASRAP) of Raynaud's burden (p=0.009) and weekly attack reduction (p=0.03)
- Across all assessed Raynaud's metrics, including pain, severity, and burden, and several Scleroderma-related measures assessed with the SHAQ PRO instrument (all-cause pain, GI dysfunction, disability, overall SSc disease severity and breathing) showed a numerical benefit with AISA‑021–treated patients compared with placebo
- AISA-021 was generally well-tolerated, with no treatment-related serious adverse events (SAE) reported in all groups, and an overall incidence of adverse events comparable to placebo
Aisa Pharma has submitted a Type C meeting request to the U.S. FDA to discuss and seek alignment on the development strategy and potential registration pathway for AISA-021 in SSc RP.
Details of the Presentations:
Presenter: Francesco Del Galdo, M.D., Ph.D., Director of the Scleroderma program at Leeds Medical Center in the United Kingdom, and former President of EUSTAR (European Scleroderma Trials and Research Group)
Presenter: Andrew Sternlicht, MD, Assist. Professor of Anesthesiology, Tufts University Medical Center and AISA PHARMA, Inc.
The abstracts are available on the Publications page of the Company's website at www.aisapharma.com.
About AISA-021
AISA-021 is a novel, once-daily, investigational oral dual calcium channel inhibitor designed to promote vasodilation and endothelial homeostasis with reduced neuronal signaling, inflammation and sympathetic activation and thereby reduce vasospasm and ischemic injury in patients with systemic sclerosis–associated Raynaud's phenomenon (SSc RP). Originally approved in Japan in 1995 to treat hypertension, Aisa Pharma has developed a proprietary process to improve drug substance and a new formulation designed to specifically treat Raynaud's phenomenon. AISA-021 was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Systemic Sclerosis.
Beyond SSc RP, the company is considering AISA-021 use in systemic sclerosis, acute treatment of Raynaud's, pulmonary fibrosis, ocular applications, and specific neuropathic pain indications, reflecting the central role of N-channel activity and antagonism in these disease's pathobiology.
About Systemic Sclerosis and Raynaud's Phenomenon in Systemic Sclerosis
Systemic Sclerosis (SSc) is a fatal autoimmune illnesses and affects approximately 148,000 patients in the United States. Approximately 38% die of the disease within 10 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, often as a result of exposure to cold temperatures, which can cause severe pain, tingling, and numbness 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 in the world for the treatment of Raynaud's.
About Aisa Pharma Inc.
Aisa Pharma is a clinical-stage biopharmaceutical company dedicated to developing and commercializing new disease-modifying treatments for patients with serious rare diseases. The Company's lead program, AISA-021, is an investigational oral dual channel calcium antagonist, designed to promote vasodilation and support endothelial homeostasis. By reducing neuronal signaling, inflammation, and sympathetic activation, AISA-021 aims to reduce vasospasm and ischemic injury in patients with SSc RP.
Aisa Pharma is headquartered in Boston, Massachusetts with operations in Sydney, Australia and around the globe. For further information, please visit www.aisapharma.com and follow the company on LinkedIn.
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