Akaal Pharma Pty Ltd has announced positive results from its Phase 2 clinical trial of Takp-119, a selective Sphingosine-1-Phosphate-receptor subtype-1 (S1P1) agonist, for the treatment of atopic dermatitis and associated pruritus. The multicenter, randomized, double-blind, placebo-controlled study aimed to evaluate the drug in patients with mild to moderate atopic dermatitis (AD), a chronic inflammatory skin condition that significantly affects quality of life due to persistent itching.
The study showed that Takp-119 significantly reduced both skin inflammation and itching after two weeks of topical treatment. The drug demonstrated a 63.3% reduction in the Lesion Eczema Severity Index (L-ESI) score, compared to a 21.5% reduction in the placebo group. Additionally, there was a 72.7% reduction in the Visual Analogue Scale (VAS) for pruritus, compared to just 1.45% in the placebo group. Notably, 69.7% of patients achieved mild or no pruritus, compared to 2.9% in the placebo group.
Takp-119 met both primary and secondary endpoints, significantly reducing disease severity and itching. The drug was well tolerated, with no side effects typically seen with other therapies. It showed a favorable safety profile, with no occurrences of bradycardia and minimal immune suppression, setting it apart from other S1P1 agonists.
These promising results suggest that Takp-119 could address a critical need for a safe and effective non-steroidal treatment for atopic dermatitis and pruritus. Dr. Tony Rajic, CEO of Akaal Pharma, expressed confidence in the drug’s potential, calling the study a significant milestone for the company as it continues to develop new treatments.
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