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”
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.
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.
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.
Dermaliq Therapeutics Inc.
Dr. Frank Loescher
Chief Executive Officer
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.