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Year: 2022

Dermaliq Therapeutics announces first participant randomized in Phase 1b/2 trial evaluating DLQ01 solution for treatment of androgenic alopecia

Wilmington, Delaware, December 14, 2022 – 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 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,“ 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.

Contacts

Dermaliq Therapeutics Inc.
Dr. Frank Loescher
Chief Executive Officer
Email: info@dermaliq.com

Dermaliq Therapeutics announces first patient dosed in Phase 1b/2 trial evaluating DLQ02 for treatment of plaque psoriasis

Wilmington, Delaware, August 18, 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”

About DLQ02

DLQ02 is a liquid topical, calcineurin inhibitor with anti-inflammatory and immunomodulating properties, developed for the treatment of Psoriasis. There remains an unmet need for topical therapies, particularly for localized lesions only affecting limited body surface areas, which are usually not eligible for systemic treatments. DLQ02 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 “hyliQTM” technology is driving a growing product pipeline in key dermatological indications. We expect that the hyliQTM 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 DLQ02. 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 August 18, 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 psoriasis, DLQ02, 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 DLQ02, hyliQTM, or any of Dermaliq’s other product candidates, the potential benefits or applications of Dermaliq’s hyliQTM technology, Dermaliq’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of DLQ02 and other product candidates, and the timing the commencement of clinical trials, initial and ongoing data availability, and other development milestones.

Contacts

Dermaliq Therapeutics Inc.
Dr. Frank Loescher
Chief Executive Officer
Email: info@dermaliq.com

Dermaliq appoints Gordon Dow, PharmD, Michael Kuligowski, MD, PhD, R. Todd Plott, MD and Xavier Yon to its Dermatology Scientific and Medical Advisory Board 

New Scientific and Medical Advisory Board will play a strategic and pivotal role for Dermaliq in its mission to develop next generation dermatological products with unparalleled benefits to patients, prescribers and payers.

Wilmington (DE) USA, July 14, 2022 – Dermaliq Therapeutics, Inc. (Dermaliq), a private biopharmaceutical company with therapeutic focus on dermatology, today announces the formation of a Scientific and Medical Advisory Board composed of internationally recognized experts in dermatology, Gordon Dow (San Francisco, US,), Xavier Yon (Paris, France), Michael Kuligowski, MD, PhD (Chads Ford, US) and R. Todd Plott, MD (Dallas/Fort Worth, US). The Advisory Board is composed of key clinical investigators and industry veterans in the field who support and guide the development of unique topical medications based on our water-free hyliQ technology platform. Mr. Dow has been named Chairman of the Advisory board.

Frank Loescher, PhD, CEO Dermaliq, said, “we are pleased to welcome four highly respected members to our Scientific and Medical Advisory Board as we now advance three programs into the clinic: DLQ01 (Androgenetic Alopecia), DLQ02 (Psoriasis) and DLQ03 (Bacterial Skin and Soft Tissue Infections). The vast clinical and research expertise in dermatology of this group is invaluable for shaping Dermaliq’s current and future product development strategy. The board and the entire team look forward to working closely with them.”

Gordon Dow, PharmD (Chairman) is former CEO, Founder & CTO  of Dow Pharmaceutical Sciences Inc, a dermatology specialty company which developed topical products on a proprietary basis, as well as for pharmaceutical and biotechnology companies.  Dow was acquired by Valeant, now Bausch Health, for US$ 400 million in 2008. Dr. Dow is a recognized expert in topical product formulations and a leading innovator for a number of approved and successful dermatology products.    

Dr. Dow said, “Dermaliq’s hyliQ platform is a step forward in topical formulations and has the potential of being the first real game-changer in dermal delivery since decades.”

Michael Kuligowski, MD, PhD, MBA, is Vice President, Global Product Development, Dermatology at Thermo Fisher. He is an experienced industry dermatologist with 12 years of clinical practice in dermatology, primarily in an academic setting, with strong scientific and clinical background. His pharmaceutical experience spans 25+ years in companies of various sizes In Europe and in North America. Among other successes, Dr. Kuligowski played a key role in the development and approval of the first topical JAK-inhibitor at Incyte where he served as Executive Medical Director, Inflammation & Autoimmunity.

Dr. Kuligowski stated “Better and more effective topical products are needed to serve the needs of patients and practicing physicians. Innovation in the topical space is needed to develop formulations which can provide safe, enhanced drug delivery, especially for substances which are difficult to solubilize and maintain stability. Dermaliq’s novel drug delivery has the promise to address these needs”.

R. Todd Plott, MD, is a board-certified dermatologist in the Dallas/Fort Worth area and Chief Medical Officer of Epiphany Dermatology with 30 years of experience in clinical dermatology. Before entering private practice, Dr Plott spent 16 years in the pharmaceutical industry developing several dermatology drugs widely prescribed by dermatologists, his most notable invention is Solodyn.

“Treatment of dermatology diseases remains unsatisfactory for many patients. Dermaliq’s lead developments in psoriasis and skin infections offer an intriguing proposition if confirmed in the upcoming clinical trials” said Dr. Plott.

Xavier Yon, is former CEO of Galderma and a seasoned healthcare executive with an extensive background in dermatology. Previous roles include executive positions with Pfizer, Solvay, Alcon and most notably as Chief Executive Officer of Galderma for 17 years. During his time at Galderma Mr. Yon built the company from its initial spin out from Alcon to be a world leader in ethical dermatology. Mr. Yon holds a number of active board and advisor roles. He holds a degree in Physics, Chemistry and Biology from Sorbonne University, Paris.

“Dermaliq offers the opportunity to establish a highly attractive product portfolio based on its hyliQ platform, with increased patient compliance and greater patient satisfaction due to the unique platform-related cosmetic properties”, said Mr. Yon.

About Dermaliq:

Dermaliq Therapeutics, Inc. is a private company founded in 2021 through a spin off from Novaliq to reimagine topical dermatology. The Company is incorporated in Wilmington (DE), USA under Delaware law.

Dermaliq’s mission is to develop a new generation of superior topical therapeutics and medical skin care products with greater efficacy and fewer unwanted side effects for millions of patients. The unique “hyliQTM” technology is driving a growing product pipeline in key dermatological indications. The technology offers superior bioavailability, stability and cosmetic acceptability.

Dermaliq secured USD 15 million in a series A round to advance three transformative skin care drug therapies through clinical trials. Key shareholders are Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd.

For further information please contact

Dermaliq Therapeutics Inc.
Dr. Frank Loescher
Chief Executive Officer
Email: info@dermaliq.com

Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into the Clinics

  • Dermaliq Therapeutics, Inc. is an independent private pharmaceutical company emerged from Novaliq
  • Spin-off to unlock value in the space of medical dermatology by using Novaliq’s transformative technology outside eye care
  • 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd join as new investors
  • Proceeds will be used for three Phase 1/2a clinical development programs in dermatology

Wilmington (DE) USA, January 18, 2022  Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. today announced the establishment of Dermaliq Therapeutics, Inc (Dermaliq), a newly formed Delaware-based pharmaceutical development company, and the signing of a USD 15 million Series A financing round. 3E Bioventures Capital, a leading international life science investor, led the round and was joined by Beijing Whale Technology Corporation Ltd. Dermaliq´s existing shareholder Novaliq has transferred, and licensed Intellectual Property (IP) related to the field of dermatology to Dermaliq.

Skin diseases are the fourth leading cause of non-fatal disease burden worldwide, underscoring the role of dermatology in the growing field of global health. Skin conditions have significant impact on patients’ well-being, mental health, and social participation. Although topical and local delivery of active ingredients to diseased skin is the preferred treatment route for the majority of patients, current therapies often lack satisfactory skin penetration and patient compliance.

Dermaliq is developing the next generation of skin care therapies to enhance targeted penetration into skin tissues and to reduce unwanted side effects for millions of patients. The unique and proprietary technology now owned by Dermaliq, called hyliQTM, is designed to allow cutaneous drug delivery with unmatched bioavailability. The technology enables the development of superior, highly effective liquid drug products with exceptional cosmetic properties.

The proceeds will be used to conduct three Phase 1/2a clinical dermatology programs with the goal to demonstrate safety and efficacy and to advance this novel skin care drug category to market to improve the lives of millions of patients:

  • DLQ01 is a liquid drug candidate for the topical treatment of female and male androgenetic alopecia, targeting the prostamide E2 (PGE2) receptor in hair bulbs through specific follicular drug delivery.
  • DLQ02 is a novel and liquid topical calcineurin inhibitor drug therapy for plaque psoriasis, particularly in difficult to treat areas.
  • DLQ03 is a broad-spectrum liquid antibiotic drug candidate that targets topical treatment of bacterial skin and soft tissue infections, including the reduction of antibiotic-resistant strains.

The Company has demonstrated proof-of-principle for enhanced topical drug delivery using hyliQTM in nonclinical models for all three applications.

“We are excited that 3E Bioventures Capital and Beijing Whale Technology Corporation have committed to support Dermaliq as new investors in the Series A round “, said Dr. Frank Löscher, Chief Executive Officer of Dermaliq. “Our spin-off from Novaliq and successful raising of significant funds provides us with the opportunity to build a leading specialty pharmaceutical company and expand the application of Novaliq’s transformative drug delivery technology into dermatology.”

“3E is committed to investing in global leading life sciences and biomedical companies and help them grow with access to globalized resources and capabilities“, said Karen Liu, Managing Director 3E Bioventures Capital. “Dermaliq is using a unique, and scientifically sound technology to achieve high efficiency drug delivery across the skin. The technology is already proven in ophthalmology and holds great promise for dermatology. We will be excited to explore additional drug pipelines in China and synergize with Dermaliq on both pre-clinical and clinical development.”

“Whale Technology values the solid science foundation of Dermaliq’s proprietary hyliQTM technology platform”, said Ming Gao, founder and Chief Executive Officer of Whale Technology Co. Ltd. “Dermaliq’s founding team demonstrates a great combination of science, clinical experience and commercialization strength. We see great potential of Dermaliq’s pipeline in the field of dermatology after Novaliq’s proven clinical and commercial success in ophthalmology.“

“Dermatology is the logical next step into using Novaliq’s proprietary technology platform outside eye care,” said Dr. Christian Roesky, Chief Executive Officer Novaliq. “The spin-off into an independent company allows Dermaliq to greatly benefit from our experience in ophthalmology while being fully committed to the multiple product development activities in dermatology, and likely to further broaden its pipeline to other skin conditions.”

To reflect the new shareholder structure, Karen Liu of 3E Bioventures Capital will join Dermaliq’s Board of Directors. Dr. Löscher has also transitioned from his role as Chief Technology Officer at Novaliq to lead Dermaliq as its CEO & President.

About Dermaliq:

Dermaliq Therapeutics, Inc. is a private company founded in 2021 through a spin off from Novaliq to reimagine topical dermatology. The Company is incorporated in Wilmington (DE), USA under Delaware law. The company has signed a USD 15 million series A round to advance three transformative skin care drug therapies through clinical trials. Key shareholders are Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd.

About 3E Bioventures Capital:

3E Bioventures Capital is a healthcare venture capital firm, dedicated to investing in cutting-edge life sciences and biomedical technologies, with a focus on breakthrough first-in-class therapies and disruptive cross-disciplinary innovations in medical devices and diagnostics. 3E Bioventures takes on a science-driven, entrepreneur-friendly investment philosophy by working closely with companies and research institutions to develop drugs or products that have strong unmet medical needs. With offices in Beijing, Shanghai, and the San Francisco Bay Area, 3E Bioventures leverages its experience, capabilities, and network to help companies tap into markets and resources across the Pacific and advance with greater speed and capital efficiency. The motto of 3E Bioventures Capital is captured in its name 3E: Expertise, Efficiency, Execution.

About Beijing Whale Technology Corporation Ltd.:

Beijing Whale Technology Corporation Ltd. is a China-based pharmaceutical group committed to the long-term sustainable development in the fields of chemistry, pharmaceuticals and aesthetics. With more than 20 years of history, Whale Tech. has developed two core business units. On one hand, Whale Pharmaceutical Co. Ltd., Whale Chemistry Co. Ltd. and Whale Pharmatech Co. Ltd. are grouped as pharmaceutical and chemistry business unit. On the other hand, Whale Biotech is a research stage biotech company with the focus of developing aesthetics products.

About Novaliq:

Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free eyedrop technology. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies.

For further information please contact:

Dermaliq Therapeutics Inc.
Dr. Frank Löscher
Chief Executive Officer
Email: info@dermaliq.com