Akaal Pharma, a clinical-stage biopharmaceutical company, has received approval to initiate a randomized, double-blind, placebo-controlled phase-II clinical trial of its topical drug candidate AKP-11. AKP-11 is a novel First-in-Class topical Sphingosine 1-Phosphate receptor-1 (S1P₁) modulator for the treatment of mild-to-moderate plaque psoriasis in patients. Patients will be treated daily for six weeks with the topical drug AKP-11.

“We are pleased with the results of our recently completed phase I clinical trial in which our drug candidate AKP-11 has shown an excellent safety, tolerability and efficacy for treating psoriasis. We look forward to initiating our phase II clinical trial for demonstrating clinical efficacy, safety and tolerability in patients with mild-to-moderate psoriasis. This milestone advances us one step closer to our goal of providing new safer and effective treatments to physicians to help patients with psoriasis and other dermatological conditions,” said Dale Dhanoa, Ph.D., CEO of Akaal Pharma.

AKP-11 is a novel, potent and highly selective sphingosine 1-phosphate receptor-1 (S1P₁) modulator undergoing clinical development for treating psoriasis, atopic dermatitis and other skin diseases. AKP-11 was found to be safe, well-tolerated and demonstrated significant efficacy in a recently completed phase I clinical trial and a intensive nonclinical drug discovery and development.

Psoriasis is an autoimmune/inflammatory skin disorder affecting more than 2% of the global population. Psoriasis is a chronic disease that requires long-term treatment. Nearly 80% of patients have mild-to-moderate psoriasis. Psoriasis is characterized by the presence of red, scaly patches that are inflamed and produce excessive skin-cells. Psoriasis is characterized by marked infiltration of leukocytes into the dermis and epidermis, oedema, vascular leak, severe hyperplasia and inflammatory cytokine up-regulation.