Friday, August 19, 2022
Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis.
“DLQ02 evaluates for the first time hyliQTM, a novel platform technology in dermatology to create best in-class topical therapies with superior bioavailability,” said Betsy Hughes-Formella, PhD, Chief Scientific Officer at Dermaliq. “Calcineurin inhibitors for the treatment of psoriasis are a standard of care when given orally, albeit being associated with significant risk for systemic side effects. DLQ02 is designed to overcome the challenges of topical delivery of this drug class with reduced risk profiles. We are convinced DLQ02 has the potential to transform topical psoriasis therapy for millions of patients.”
The randomized, single-center, double-blind, vehicle-controlled Phase 1b/2a trial at the Centre of Human Disease Research (CHDR), Leiden, The Netherlands, is designed to evaluate the safety and efficacy profile of two dose strengths of DLQ02 and its vehicle in patients diagnosed with mild to moderate plaque psoriasis. A targeted total of 36 patients, 12 per treatment group, will be enrolled. Trial completion is expected in Q2 2023.
“DLQ02 is the first of three clinical trials in dermatology we are initiating in 2022, “said Frank Loescher, PhD, CEO & President of Dermaliq. “This is a significant step towards Dermaliq's goal of developing a new generation of superior topical drug therapies and medical skin care products. We can progress rapidly from preclinical to clinical stage building on our comprehensive safety and manufacturing experience with the hyliQTM technology. Based on the same technology (EyeSol® from Novaliq), two ophthalmology products for the treatment of Dry Eye Disease (CyclASol, NOV03), are currently in registration with New Drug Applications (NDAs) submitted to FDA”