Aisa Pharma Inc. Reports Encouraging Phase II Results for AISA-021 in Systemic Sclerosis-Related Raynaud’s Phenomenon

Clinical-stage biotech company Aisa Pharma has announced positive findings from its Phase II RECONNOITER trial evaluating AISA-021 (cilnidipine) for the treatment of **Raynaud's phenomenon associated with Systemic Sclerosis.

The results were presented at the World Systemic Sclerosis Congress held in Athens, Greece.

Although the study did not reach statistical significance on its primary endpoint, the investigational therapy demonstrated meaningful improvements across several clinical outcomes, supporting its potential advancement to Phase III development.

Improvements in Raynaud’s Attack-Free Days and Duration

The Phase II trial showed that AISA-021 improved multiple measures of Raynaud’s symptoms, including the number of attack-free days and attack duration.

Key findings from the RECONNOITER study include:

• 22.1% reduction in weekly Raynaud’s attack frequency with AISA-021 compared to 12.4% with placebo
• Significant increase in attack-free days, showing a 155% placebo-adjusted improvement
• Significant reduction in attack duration
• Improved skin temperature measurements during thermographic assessment

In addition, responder analysis showed that more than twice as many patients receiving AISA-021 achieved a ≥70% reduction in attack frequency or meaningful improvement in Raynaud’s symptoms compared with placebo.

Additional Benefits Beyond Raynaud’s Symptoms

Beyond Raynaud’s attack metrics, the therapy also showed improvements in broader systemic sclerosis-related symptoms. Patients treated with AISA-021 experienced numerical improvements across multiple health measures, including:

• Pain reduction
• Gastrointestinal symptoms
• Breathing difficulties
• Overall disease severity
• Functional disability

These outcomes were measured using the SHAQ PRO instrument, a validated patient-reported outcome tool for systemic sclerosis.

Favorable Safety and Tolerability Profile

AISA-021 demonstrated a safety profile comparable to placebo in the trial.

Key safety observations included:

• No treatment-related serious adverse events
• Good overall tolerability across treatment groups
• Patients were able to take AISA-021 alongside existing standard-of-care therapies

Importantly, about 70% of participants were already receiving stable treatments for Raynaud’s symptoms, suggesting the drug may provide additional benefits on top of existing therapies.

Trial Design and Study Population

The RECONNOITER trial was a randomized, double-blind, placebo-controlled Phase II study designed to evaluate the safety and efficacy of once-daily oral AISA-021.

Study highlights:

• 64 patients enrolled with systemic sclerosis-associated Raynaud’s phenomenon
• Conducted in two parts:
  • Part A: Parallel dose-evaluation study (10 mg and 20 mg doses)
  • Part B: Randomized crossover study involving 37 patients
• Patients continued standard treatments while receiving AISA-021 as an add-on therapy

Primary endpoint:

• Change from baseline in mean weekly Raynaud’s attack frequency

Secondary endpoints included:

• Attack severity and duration
• Raynaud’s condition score (RCS)
• Pain levels
• Number of attack-free days

Next Steps: Discussions With the FDA

Following the Phase II results, Aisa Pharma plans to hold an End-of-Phase-2 meeting with the U.S. Food and Drug Administration.

The goal is to determine:

• The design of a Phase III clinical trial
• A potential regulatory approval pathway

Researchers believe that pivotal trials may require fewer than 100 patients to demonstrate statistical significance in attack-frequency reduction.

About AISA-021

AISA-021 is an investigational once-daily oral dual calcium channel inhibitor designed to improve blood vessel function and reduce vasospasm.

The therapy works by:

• Promoting vasodilation
• Supporting endothelial health
• Reducing inflammation and sympathetic activation

The active molecule, cilnidipine, was originally approved in Japan in 1995 for hypertension. Aisa Pharma has developed a new formulation and manufacturing process tailored for Raynaud’s treatment.

AISA-021 has also received Orphan Drug Designation from the FDA.

Understanding Systemic Sclerosis and Raynaud’s Phenomenon

Systemic sclerosis (SSc) is a rare autoimmune disease affecting approximately 100,000 people in the United States. The disease is associated with high mortality, with around half of patients dying within 12 years of diagnosis.

About 95% of SSc patients experience Raynaud’s phenomenon, a condition caused by reduced blood flow to the fingers and toes, leading to:

• Severe pain
• Tingling and numbness
• Color changes in the skin triggered by cold or stress

Despite its burden, no oral drug has been globally approved specifically for Raynaud’s phenomenon associated with systemic sclerosis.

About Aisa Pharma Inc.

Aisa Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for serious rare diseases.

Headquartered in Boston, Massachusetts, the company operates globally with additional activities in Sydney, Australia.

Its lead program, AISA-021, aims to provide a disease-modifying therapy for systemic sclerosis-related Raynaud’s phenomenon and potentially other vascular and inflammatory conditions.

Bottom line:

The Phase II RECONNOITER trial results suggest that AISA-021 could become a promising new treatment option for systemic sclerosis-related Raynaud’s phenomenon, a condition that currently lacks approved oral therapies worldwide.

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