The first participant has been randomized in a Phase 1b/2a trial of Dermaliq Therapeutics Inc.’s DLQ01 solution in men with androgenic alopecia.

The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ01 in men with androgenic alopecia.

“Topical application of prostaglandin F2α analogue eyedrops has already been demonstrated to grow eyelashes when used to treat glaucoma. These agents could potentially also stimulate hair regrowth in androgenic alopecia in man and woman. However, to date difficulties in topical delivery of this class of compounds into the hair follicle have limited their development,” says Prof. Rod Sinclair, MD, Professor of Dermatology at the University of Melbourne, and Director of Epworth Dermatology, in a news release.

DLQ01 is designed to overcome the challenges of topical delivery of this drug class with an excellent safety profile. “This trial evaluates how the unique properties of a topical formulation based on hyliQ, Dermaliq’s novel platform technology in dermatology to create best in-class topical therapies with superior bioavailability, can facilitate targeted delivery of a Prostaglandin F2α analogue into hair follicles,” says Betsy Hughes-Formella, PhD, Chief Scientific Officer at Dermaliq. “We are convinced that Dermaliq’s hyliQ technology has the potential to transform follicular and dermal delivery of a broad range of active ingredients and that DLQ01 is just the start of a promising pipeline targeting follicular delivery.”

This randomized, blinded, vehicle-controlled Phase 1b/2a trial at Sinclair Dermatology, Melbourne Australia is designed to evaluate the safety and efficacy profile over a 6-month treatment period of two dose strengths of DLQ01 and its vehicle and compared against the market product Rogaine (Minoxidil) in men diagnosed with androgenic alopecia. A targeted total of 120 patients, 30 per treatment group, will be enrolled. Trial completion is expected in Q4 2023.

“DLQ01 is the third clinical trial in dermatology we initiated in 2022,” says Frank Loescher, PhD, CEO & President of Dermaliq. “This is a significant achievement towards Dermaliq's goal of developing a new drug category of superior topical prescription therapeutics alongside medical skin care OTC products that address the significant unmet medical need for safe and effective therapies for patients in dermatology.

Delivering clinical proof of concept data with our game-changing, proprietary, hyliQ technology platform in three different major dermatology indications by 2023 will open the door to new partnerships and support our goal to become a leading, dermatology-focused pharmaceutical company with global reach.”

About DLQ01

DLQ01 solution is a topical prostaglandin (PG) F2α drug, designed to stimulate scalp hair growth in men and women suffering from androgenic alopecia, also known as male and female pattern baldness. DLQ01 has the potential to provide a highly effective and safe treatment option.

Dermaliq’s mission is to develop a new generation of superior topical drug therapies and medical skin care products with greater efficacy and fewer unwanted side effects for millions of patients. The unique “hyliQ” technology is driving a growing product pipeline in key dermatological indications. We expect that the hyliQ technology will offer superior bioavailability, stability and cosmetic acceptability as compared to currently marketed products.