Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage dermatology and medical aesthetics company,  announced statistically significant topline data from a randomized, blinded, vehicle and comparator-controlled clinical Phase 1b/2a trial in men with androgenetic alopecia (male pattern baldness, AGA) for its topical product candidate DLQ01, a prostaglandin F2α analog, based on Dermaliq’s novel hyliQ® technology platform.

The study objectives were to evaluate preliminary efficacy, safety and pharmacokinetics of topical DLQ01, applied twice daily to the vertex balding area for 6 months. 120 men in the age between 18 – 60 years (Norwood-Hamilton, vertex grades III – V) were equally randomized into four treatment groups of N=30: DLQ01, DLQ01 low dose, DLQ01 vehicle, and the active comparator minoxidil 5%.

Endpoints included the changes from baseline at the end of the study at six months in target area hair counts (TAHC), anagen to telogen ratios, and cutaneous safety. The trial was conducted at Sinclair Dermatology, Melbourne Australia.

DLQ01 treatment increased TAHC by 12.3% from baseline, with a highly statistical significance (p=0.008) compared to vehicle. 83% of subjects responded with a positive change in hair growth. The comparator minoxidil increased TAHC to baseline by 9.8%.

All DLQ01 treatment arms were well tolerated. No treatment related cutaneous adverse events as defined in the protocol were observed. Scattered dermal tolerability reactions were observed which were mostly rated as mild across all treatment groups. None of the cutaneous reactions led to treatment discontinuation or interruption.

"It has been more than 20 years since the FDA approved minoxidil 5% solution for male androgenetic alopecia. While effective in many men there still remains a huge unmet need for a safe, effective, and easy to use topical treatment for AGA. The DLQ01 phase II data is robust and very exciting. DLQ01 is potentially the first new topical treatment option for both men and women suffering from AGA in a very long time. The DLQ01 mode of action is novel. It involves modulation of the PEG2α receptor. Combined with a promising safety profile, DLQ01 could be just what our patients have been waiting for." said Prof. Rodney Sinclair, MD, Professor of Dermatology at the University of Melbourne, Director of Epworth Dermatology, and Principal Director at Sinclair Dermatology, the Principal Investigator in the clinical trial.

“We are especially excited that this trial shows a clear differentiation from the leading market product minoxidil in terms of efficacy and potential compliance”, said Betsy Hughes-Formella, PhD, Chief Scientific Officer & Co-Founder of Dermaliq. “In addition to the sustained improvement in hair growth, there are observations suggesting a differentiation depending on the severity of AGA as well as in hair type subgroups. We plan to publish these exciting scientific data in a peer reviewed journal in the near future.”

Dr. Hughes-Formella added, "Alongside the favorable safety and tolerability observed for DLQ01 in this trial, we have identified a clear regulatory pathway to approval that we will now discuss further with the FDA.”

“These results impressively demonstrate the superiority of our hyliQ^® technology platform for the targeted delivery of active ingredients into hair follicles”, said Dr. Frank Loescher, CEO & Co-Founder of Dermaliq. “We think this is a potentially game-changing treatment for androgenetic alopecia due to its strong efficacy and safety, combined with its excellent cosmetic properties and its ease of use. DLQ01 has the potential to become the leading next-generation hair growth product. We feel encouraged to accelerate our efforts to complete the clinical development and to make DLQ01 available to men and women suffering from baldness.”