Dermata Receives Approval from FDA for the Proprietary Name Xyngari(TM)

Rhea-AI Summary

Dermata Therapeutics (NASDAQ:DRMA) announces FDA approval for the proprietary name Xyngari (formerly DMT310) for its Phase 3 acne treatment candidate. The approval is contingent on successful submission and acceptance of a new drug application (NDA). Topline results from the first Phase 3 STAR-1 study are expected in March 2025.

The STAR-1 study is a randomized, double-blind, placebo-controlled trial involving 520 patients with moderate-to-severe facial acne. The study evaluates once-weekly treatment over 12 weeks, with primary endpoints including changes in lesion counts and Investigator Global Assessment scores. If successful, Xyngari could become the first safe, effective, once-weekly topical acne treatment.

Positive

• FDA approval of proprietary name Xyngari, marking progress toward potential commercialization
• Recent notice of allowance for US patent covering Xyngari for acne treatment
• Large-scale Phase 3 trial with 520 patients enrolled
• Potential first-mover advantage as a once-weekly topical acne treatment

Negative

• Phase 3 results not expected until March 2025
• Second Phase 3 study still required before NDA submission
• Final FDA approval contingent on successful NDA submission and acceptance

Insights

Medical Research Analyst

The FDA's approval of the proprietary name Xyngari represents a key milestone in DRMA's regulatory pathway, though it's a preliminary step contingent on future NDA approval. The ongoing Phase 3 STAR-1 trial with 520 patients is particularly noteworthy for its once-weekly dosing regimen, which could offer a significant competitive advantage in the crowded acne treatment market. The trial's robust design - double-blind, placebo-controlled with a 2:1 randomization - and comprehensive endpoints including both lesion counts and IGA scores align with FDA requirements for acne therapeutics.

The study's large sample size and inclusion of patients from multiple regions enhance the statistical power and potential generalizability of results. However, investors should note that success in the STAR-1 trial alone won't be sufficient - a second Phase 3 study will be required for NDA submission, indicating a significant pathway ahead before potential commercialization.

Market Research Analyst

For a micro-cap company with a market cap of just $2.2M, this development program represents an ambitious undertaking in the lucrative acne treatment market. The once-weekly application could be a significant differentiator in a market dominated by daily-use products. However, the extended timeline to potential commercialization - with topline results not expected until March 2025 and a second Phase 3 trial still required - presents considerable financial considerations given the company's current market capitalization.

The recent patent allowance mentioned strengthens the company's intellectual property position, but the key catalyst remains the March 2025 topline data. The acne treatment market is highly competitive, with both established players and new entrants, making the commercial success of Xyngari, if approved, dependent on its ability to demonstrate superior efficacy or convenience advantages over existing options.

- Xyngari (formerly DMT310) is currently being studied in Phase 3 for the treatment of acne, with topline results from the first Phase 3 STAR-1 study expected in March 2025 -

SAN DIEGO, CA / ACCESSWIRE / December 16, 2024 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions, today announced that it received approval from U.S. Food and Drug Administration (FDA) of the proprietary name, Xyngari (pronounced zin-gar-ee) (formerly DMT310), for its Phase 3 clinical drug candidate in acne. The proprietary name, Xyngari, is approved pending the successful submission and acceptance of a new drug application (NDA).

"The FDA approving the Xyngari name is just one more successful step our team has completed in the development program for this unique product candidate," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "Having an approved proprietary name with the approaching Phase 3 acne topline results expected in March 2025, and recent notice of allowance of a US patent covering Xyngari for the treatment of acne, we believe, positions Dermata well to complete this development program and eventually file an NDA. Our team is excited about the prospect of making Xyngari available to patients, if approved, as we see great commercial opportunity for Xyngari, as it is potentially the first safe, effective, once-weekly, topical product to treat acne," concluded Mr. Proehl.

Xyngari Phase 3 STAR-1 Clinical Study Design

The Xyngari Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical study will evaluate the efficacy, safety, and tolerability of Xyngari in patients with moderate-to-severe facial acne. The STAR-1 study is a randomized (2:1), double-blind, and placebo-controlled study with 520 patients enrolled with moderate-to-severe acne, ages 9 years and older in the United States and Latin America. The primary endpoints include the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response. IGA is measured on a 5-point scale (0-4), with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients are treated once-a-week for 12 weeks with either Xyngari or placebo and are evaluated monthly. The STAR-1 study is the first of two pivotal Phase 3 studies required by the FDA, of which the second Phase 3 study will be followed by an extension study. If positive, the results from both Phase 3 studies would be used to support the filing of an NDA with FDA.

About Xyngari (formerly DMT310)

Xyngari is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. Xyngari has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. Xyngari has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where once weekly applications achieved statistically significant results at all timepoints for all primary and secondary endpoints. Xyngari also saw almost 45% of patients achieving an IGA score of clear or almost clear compared with less than 18% for placebo patients.

About Dermata Therapeutics

Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions. The Company's lead product candidate, Xyngari (formerly DMT310), is the first product candidate being developed from its Spongilla technology platform. Xyngari is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, Xyngari has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses Xyngari as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin diseases and conditions. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: expectations with regard to the potential market acceptance of any of the Company's product candidates; timing of trials and data events; expectations with regard to the timing and/or results or responses from meetings with regulatory bodies, including the FDA; the success, cost, funds available, and timing of its product candidate Xyngari development activities and ongoing and planned clinical trials; and whether the results of Xyngari will lead to future product development or approvals. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com

SOURCE: Dermata Therapeutics

View the original press release on accesswire.com

FAQ

When will Dermata (DRMA) release Phase 3 STAR-1 results for Xyngari?

Dermata expects to release topline results from the Phase 3 STAR-1 study for Xyngari in March 2025.

How many patients are enrolled in Xyngari's STAR-1 Phase 3 trial?

The STAR-1 Phase 3 trial has enrolled 520 patients with moderate-to-severe acne, ages 9 years and older in the United States and Latin America.

What makes Xyngari (DRMA) unique in the acne treatment market?

Xyngari is potentially the first safe, effective, once-weekly topical product for acne treatment, distinguishing it from existing daily-use products.

What are the primary endpoints for Dermata's (DRMA) STAR-1 Phase 3 trial?

The primary endpoints include mean change from baseline in inflammatory and noninflammatory lesion counts, and the Investigator Global Assessment (IGA) treatment response.

How many Phase 3 trials does Dermata (DRMA) need for Xyngari FDA approval?

Dermata needs to complete two pivotal Phase 3 studies required by the FDA, followed by an extension study, before filing an NDA.