Dermata Receives Notice of Allowance for New U.S. Patent for DMT310 for the Treatment of Acne

Rhea-AI Summary

Dermata Therapeutics (NASDAQ: DRMA) has received a notice of allowance from the USPTO for a new patent application for its DMT310 product, targeting acne treatment. This marks Dermata's first allowed U.S. patent application for DMT310, which utilizes Spongilla technology for topical acne treatment.

The company has completed enrollment in its DMT310 Phase 3 STAR-1 study and expects to announce topline results in March 2025. The market potential is significant, with over 30 million acne patients seeking treatment annually in the U.S., where topical products serve as first-line therapy.

Positive

• Receipt of first U.S. patent allowance for DMT310 strengthening IP protection
• Completed enrollment in Phase 3 STAR-1 study
• Large market opportunity with 30 million annual acne patients in the U.S.

Negative

• Phase 3 results not expected until March 2025
• Product still pending FDA approval

Insights

Medical Research Analyst

The patent allowance for DMT310 represents a significant intellectual property milestone for Dermata's acne treatment pipeline. The timing aligns strategically with their ongoing Phase 3 STAR-1 clinical trial, providing important IP protection ahead of potential commercialization. With over 30 million U.S. acne patients seeking treatment annually, DMT310's once-weekly application schedule could offer a compelling advantage over current daily-use topical treatments.

The novel Spongilla technology platform differentiates DMT310 in the crowded acne treatment market. However, market success will ultimately depend on the Phase 3 trial results expected in March 2025. The patent strengthens Dermata's competitive position and potential commercial value, but investors should note that regulatory approval remains the critical next milestone.

Legal Expert

The USPTO's notice of allowance significantly enhances Dermata's intellectual property portfolio. This first U.S. patent for DMT310 will provide essential market exclusivity, protecting the company's commercial interests upon potential FDA approval. The patent's scope, covering both compositions and treatment methods, offers broad protection for the Spongilla technology platform.

For a small-cap biotech company ($2.6M market cap), strong IP protection is important for maintaining competitive advantages and attracting potential partnerships or acquisitions. This patent allowance could increase Dermata's negotiating leverage with larger pharmaceutical companies and enhance its overall market valuation.

- This is Dermata's first allowed U.S. patent application for DMT310, using its Spongilla technology to topically treat acne -

- Dermata recently completed enrollment in its DMT310 Phase 3 STAR-1 study for the treatment of acne and expects to announce topline results in March 2025 -

- Over 30 million acne patients seek treatment in the U.S. each year, with topical products being first-line therapy -

SAN DIEGO, CA / ACCESSWIRE / December 10, 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 receipt of a notice of allowance from the United States Patent and Trademark Office of a new patent for its DMT310 product candidate for the treatment of acne. The allowed patent application, entitled "Compositions and methods for the treatment of skin conditions" (U.S. Application No. 17/420,635), further strengthens Dermata's intellectual property for DMT310.

"We are thrilled to receive this notice of allowance in the U.S., which we believe further validates DMT310's novel approach to treat acne with a once weekly topical product," commented Gerry Proehl, Dermata's Chairman, President, and CEO. "Given the unique features and benefits of DMT310, we believe, if approved, it could potentially transform the current acne treatment guidelines and allow DMT310 to be a first-line treatment option. We also recently completed enrollment in the first of two DMT310 Phase 3 studies and are eager to announce topline results in March of 2025. We look forward to this allowed patent application eventually advancing to issuance and support our intellectual property protections for DMT310."

About DMT310

DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. DMT310 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. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. DMT310 also observed almost 45% of patients achieving an IGA score of clear or almost clear compared with less than 18% of placebo patients achieving the same at the end of 12 weeks.

About Acne Vulgaris

Over 30 million acne patients in the U.S. seek treatment each year, with about 85% of teenagers experiencing some form of acne, and some individuals suffering from acne well into their 30s, 40s, and beyond. Acne is characterized by areas of scaly red skin, noninflammatory blackheads and whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring, which can present on the face, neck, chest, back, shoulders, and upper arms. While not life-threatening, acne can cause significant trauma for those suffering from it due to social stigmas, substantial risk of permanent facial scarring, lowered self-esteem, and social withdrawal.

About Dermata Therapeutics

Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions and diseases. The Company's lead product candidate, DMT310, is the first product candidate being developed from its Spongilla technology platform. DMT310 is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, DMT310 has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its DMT310 product as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin conditions and diseases. 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 DMT310 development activities and ongoing and planned clinical trials; whether the results of DMT310 will lead to future product development or approvals; whether pending patent applications including the allowed patent application will proceed to allowance without interruption, if at all, and whether pending or issued patents will provide adequate protection for the Company's product candidates, if approved. 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) announce DMT310 Phase 3 STAR-1 topline results?

Dermata expects to announce topline results from the DMT310 Phase 3 STAR-1 study in March 2025.

What is the market size for Dermata's (DRMA) DMT310 acne treatment?

Over 30 million acne patients seek treatment in the U.S. each year, with topical products being first-line therapy.

What patent did Dermata (DRMA) receive for DMT310?

Dermata received a notice of allowance from the USPTO for a patent titled 'Compositions and methods for the treatment of skin conditions' (U.S. Application No. 17/420,635) for DMT310 acne treatment.