Greater Shepparton, Victoria, Australia – 10 June 2025: Akaal Pharma Pty Ltd (Akaal Pharma), a biopharmaceutical company focused on novel therapies for inflammatory and autoimmune skin disorders, today announced positive top-line results from its Phase 2 clinical trial. The multicenter, randomized, double-blind, placebo-controlled study evaluated its 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 is a chronic skin inflammatory condition where pruritus significantly impacts patients’ quality of life. The Phase 2 study demonstrated statistically significant reductions in both inflammation and pruritus following two weeks of topical treatment, underscoring Takp-119 potential as a novel, effective, and non-steroidal therapy for AD.
Key results from the study include:
- A highly significant reduction of 63.3% in Lesion Eczema Severity Index (L-ESI) score (p<0.0001), compared to 21.5% in the placebo group
- A significant reduction of 72.7% in Visual Analogue Scale (VAS) for pruritus of ≥4 points, compared to 1.45% in the placebo group
- 69.7% of patients achieved mild or no pruritus in VAS, compared to 2.9% in placebo group.
Takp-119 successfully met both primary and secondary endpoints, 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, positions it as a uniquely differentiated candidate in the S1P1 agonist class.
The findings suggest Takp-119 could address a critical unmet need for a safe, effective, and non-steroidal treatment option for atopic dermatitis and related pruritus.
“This study represents a significant milestone for Akaal Pharma as we continue to actively prioritize and expand our development programs to bring new and effective treatments into the market,”
said Dr Tony Rajic, CEO of Akaal Pharma.
Media Contact:
Akaal Pharma Pty Ltd
Email: info@akaalpharma.com