Akaal Pharma has completed a Phase 1 clinical trial of its topical drug candidate AKP-11 for the treatment of patients with mild to moderate psoriasis. In this 4 week clinical study, AKP-11 was found to be safe, well tolerated and effective as a new topical therapy.
The current available topical treatments suffer from various local and systemic adverse side effects including skin irritation, skin thinning and others. AKP-11 has shown superior profile as a topical therapy as it did not show any systemic exposure. AKP-11 demonstrated significant efficacy (>40%; p=0.0016) in reducing psoriasis plaque severity with once only daily application.
A multicentre Phase 2 clinical trial for the topical treatment of psoriasis is begin in early Q3’ 2015. Phase 1 and 2 clinical studies are also planned for atopic dermatitis and other skin diseases.
In addition, Phase 1 and 2 clinical trials are also planned for the use of our oral treatment for autoimmune and inflammatory diseases particularly multiple sclerosis and ulcerative colitis.
AKP-11 is a novel, potent and selective S1P1 receptor modulator with multimodal action in the treatment of immune and inflammatory diseases.