Dermaliq Therapeutics Announces First Participant Randomized in Phase 1b/2 Trial Evaluating DLQ01 Solution for Treatment of Androgenic Alopecia

2022-12-14

临床研究

WILMINGTON, Del.--(BUSINESS WIRE)-- Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first participant randomized in a Phase 1b/2a trial with DLQ01 solution, a topical Prostaglandin F2α analogue. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ01 in men with androgenic alopecia (male pattern baldness). “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,” said Prof. Rod Sinclair, MD, Professor of Dermatology at the University of Melbourne, and Director of Epworth Dermatology. 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,” said 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 pro 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,” said 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. About Dermaliq: Dermaliq Therapeutics, Inc. is a clinical stage pharmaceutical Delaware corporation founded in 2021 through a spin off from Novaliq GmbH to reimagine topical dermatology. 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. Earlier this year, Dermaliq secured USD 15 million in a series A round to advance the development of three transformative skin care drug therapies including DLQ01. Key shareholders are Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. Forward-Looking Disclosures: Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. The information contained in this release is as of December 15, 2022. Dermaliq assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a potential topical treatment for androgenetic alopecia, DLQ01, including its potential benefits and a Phase 1b/2a clinical trial that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. You should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety, and efficacy of DLQ01, hyliQ®, or any of Dermaliq’s other product candidates, the potential benefits or applications of Dermaliq’s hyliQ® technology, Dermaliq’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of DLQ01 and other product candidates, and the timing the commencement of clinical trials, initial and ongoing data availability, and other development milestones.