Posted: 11 June 2025
Positive top-line results from a Phase 2 clinical trial were announced by Akaal Pharma Pty Ltd (Akaal Pharma), a biopharmaceutical company focused on novel therapies for inflammatory and autoimmune skin disorders. The multicenter, randomized, double-blind, placebo-controlled study evaluated the selective Sphingosine-1-Phosphate-receptor subtype-1 (S1P1) agonist, Takp-119, in patients with mild to moderate atopic dermatitis (AD) and associated pruritus.
Atopic dermatitis, a chronic skin inflammatory condition, was significantly impacted by pruritus, affecting patients’ quality of life. Statistically significant reductions in both inflammation and pruritus were demonstrated by the Phase 2 study following two weeks of topical treatment, underscoring Takp-119’s potential as a novel, effective, and non-steroidal therapy for AD.
Both primary and secondary endpoints were successfully met by Takp-119, significantly reducing disease severity and itch (pruritus) in patients with atopic dermatitis. Importantly, Takp-119 was well tolerated with no side effects typically observed in other therapies. Its favorable safety profile, particularly the absence of bradycardia and minimal immune suppression, positioned it as a uniquely differentiated candidate in the S1P1 agonist class.
A critical unmet need for a safe, effective, and non-steroidal treatment option for atopic dermatitis and related pruritus was suggested by the findings. “A significant milestone for Akaal Pharma was represented by this study as development programs were actively prioritized and expanded to bring new and effective treatments into the market,” said Dr. Tony Rajic, CEO of Akaal Pharma.
For more information, click here.
