Dermaliq Therapeutics Announces Positive Topline Results from Phase 1b/2a Trial Evaluating the Safety and Efficacy of DLQ01 for the Treatment of Androgenetic Alopecia (AGA) in Men

Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage dermatology and medical aesthetics company, today 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.”

About Androgenetic Alopecia

Androgenetic alopecia (AGA) or male/female pattern hair loss is the most prevalent type of hair loss, occurring in both sexes and across all races. It is age-dependent, with a prevalence observed to increase from approximately 30% in 30 years of age to greater than 50% prevalence by 50 years (1). Hair loss associated with AGA may have several negative psychosocial impacts, e.g., it may trigger concerns about decreasing attractiveness and thereby result in lower self-esteem (2), (3).
The medical term AGA stresses the pivotal role of androgens and genetic factors (4). In genetically predisposed men the root cause has long been considered as the binding of dihydrotestosterone, a metabolite of testosterone, with the androgen receptor in dermal papilla cells and tissues surrounding AGA-prone follicles, leading to the miniaturization of the follicles, hair thinning, and eventually AGA (5). It is now recognized that the pathogenesis of AGA is multifactorial and more complex, involving chronic micro-inflammatory and fibrotic components at a follicular level (6), (7). Targeting of potential effectors and common mediators downstream of the androgen trigger may offer new therapy options for AGA (6).

About DLQ01

DLQ01 is a proprietary hyliQ® technology based topical prostaglandin (PG) F2α drug, designed to stimulate scalp hair growth in men and women suffering from androgenetic alopecia, also known as male and female pattern baldness. DLQ01 has the potential to provide a long term effective and safe treatment option.

About Dermaliq

Dermaliq Therapeutics, Inc. is a clinical stage dermatology and medical aesthetics company, with a leading pipeline of drug candidates focusing on follicular diseases and conditions. Dermaliq was founded in 2021 as a spin-off from Novaliq GmbH, which developed the patent-protected revolutionary hyliQ® technology, on the basis of which two successful drugs for the treatment of dry eyes, Miebo® and Vevye®, have already been approved by the US-FDA.
Dermaliq is developing 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. Our unique "hyliQ®" technology, which offers a combination of excellent bioavailability, drug stability, safety and tolerability as well as cosmetic acceptability, is the foundation of a growing product pipeline in key dermatology indications.

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 July 09, 2024. 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. 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.

References

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2) Alfonso M, Richter-Appelt H, Tosti A, Viera MS, García, M. The psychosocial impact of hair loss among men: a multinational European study. Current Medical Research and Opinion 2005; 21: 1829–1836
3) Ng KF, Norazirah MN, Mazlin MB, Adawiyah J, Shamsul AS. Psychological impact, self-perception and the contributing factors in patients with androgenetic alopecia. Journal of Cosmetology & Trichology 2017; 3: 3.
4) Rossi A, Anzalone A, Fortuna MC, Caro G, Garelli V, Pranteda G, Carlesimo M. Multi-therapies in androgenetic alopecia: review and clinical experiences. Dermatologic Therapy 2016; 29: 424–432.
5) English RS. A hypothetical pathogenesis model for androgenic alopecia: clarifying the dihydrotestosterone paradox and rate-limiting recovery factors. Medical Hypotheses 2018; 111: 73–81.
6) Sadick NS, Callender VD, Kircik LH, Kogan, S. New insight into the pathophysiology of hair loss trigger a paradigm shift in the treatment approach. J Drugs Dermatol. 2017; 16 (11): s135-s140.
7) Mahé YF, Michelet J-F, Billoni N, Jarrousse F, Buan B, Commo S, Saint-Leger D, Bernard BA. Androgenetic alopecia and microinflammation. International Journal of Dermatology 2000; 39 (8): 576–584.