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news.Australian biopharmaceutical firm Akaal Pharma has reported positive results from a randomized, double-blind, placebo-controlled Phase I clinical trial of AKP-11, a topical Sphingosine 1-Phosphate receptor-1 (S1P1) modulator to treat mild-to-moderate plaque psoriasis.
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The data show that topical application of AKP-11 was safe, well-tolerated as well as resulted in a significant reduction in plaque severity.
The company said that no detectable plasma levels of AKP-11 were observed in the pharmacokinetic analysis, which is attributable to the large therapeutic index of AKP-11.
Akaal Pharma CEO Dale Dhanoa said: "Although a variety of therapies are available for treating psoriasis, there exists an underserved need for safer and effective topical treatments.
"The Phase I clinical data for AKP-11, a topical First-in-Class S1P1 modulator, is very encouraging and strongly supports our Phase II clinical trials."
A total of 16 subjects were involved in the randomized, double-blind and placebo-controlled Phase I trial, which was conducted in two parts, Phase 1A and Phase 1B.
In PART A, AKP-11 or placebo were administered as an ointment to four healthy subjects and it was extended to 12 psoriasis patients in PART B.
In the trial, patients were treated once daily with a topical application of AKP-11 for 28 consecutive days.