Aisa Pharma has reported positive results from its Phase II RECONNOITER trial of AISA-021 (cilnidipine), a once-daily calcium channel blocker, for patients with systemic sclerosis-associated Raynaud’s phenomenon (SSc RP).
The findings were presented at the 9th World Systemic Sclerosis Congress in Athens, Greece.
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The double-blind, randomised, prospective crossover, placebo-controlled trial assessed the safety and efficacy of daily oral AISA-021 in patients with active SSc RP.
It included 64 patients and was conducted in two segments: Part A used a parallel arm design to assess dose (10mg and 20mg), efficacy, co-administration, and safety with a phosphodiesterase type 5 (PDE-V) inhibitor; Part B used a crossover design with 37 patients.
The primary endpoint was the change from baseline in the mean weekly number of Raynaud’s attacks. Key secondary endpoints included severity, duration, Raynaud’s condition score (RCS), pain, and attack-free days. Patients received standard care therapies alongside AISA-021.
In the primary endpoint analysis, AISA-021 treatment led to a 22.1% reduction in the mean frequency of patient-reported weekly Raynaud’s attacks compared to baseline. Placebo-treated patients saw a 12.4% reduction; this difference did not reach statistical significance.
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By GlobalDataAISA-021 showed a significant increase in attack-free days, a placebo-adjusted rise of over 155%, and nearly four-fold improvement from baseline.
There were statistically significant reductions in attack duration and improvement in skin temperature at the proximal interphalangeal joint (PIP).
The therapy also improved non-Raynaud’s symptoms measured by the SHAQ PRO instrument for SSc, showing numerical benefits over placebo in all-cause pain, gastrointestinal dysfunction, disability, overall disease severity, and breathing.
The treatment was generally well-tolerated, and no treatment-related serious adverse events occurred across all groups.
Aisa Pharma plans to meet with the US Food and Drug Administration (FDA) and other regulatory agencies following these Phase II results, aiming to outline the Phase III clinical trial and potential registration pathway for AISA-021 in SSc RP.
Aisa Pharma founder and CEO Andrew Sternlicht said: “Systemic sclerosis-associated Raynaud’s phenomenon remains a highly burdensome manifestation of scleroderma, with no approved treatment options and significant impact on function and quality of life.
“While the Phase II study did not reach statistical significance on the primary efficacy endpoint in this small study, we believe the consistent effects observed with AISA-021 across a variety of key endpoints are very encouraging.
“AISA-021 showed significant improvements in the number of Raynaud’s attack-free days and attack duration, which were higher than those seen with currently available calcium channel blockers. AISA-021 also improved pain and other Raynaud’s symptoms while maintaining a favourable safety profile. These encouraging results provide strong support for advancing to Phase III studies.”
