Dermata Announces Positive Results from Phase 1b Clinical Trial of DMT310 for the Treatment of Mild-to-Moderate Psoriasis

Rhea-AI Summary

Dermata Therapeutics (NASDAQ:DRMA) announced positive results from its Phase 1b trial of DMT310 for treating mild-to-moderate psoriasis. The study showed that 29.6% of patients achieved a Physician's Global Assessment (PGA) score of 0 or 1, while 25.9% had a Psoriasis Area Severity Index (PASI) score of 0 or 1 after 8 weeks. Additionally, there was a 19.6% reduction in pruritus. The treatment was reported to be safe with few adverse events. Dermata plans to advance DMT310 in further clinical investigations.

Positive

• 29.6% of patients achieved a PGA score of 0 or 1.
• 25.9% of patients demonstrated a PASI score of 0 or 1.
• DMT310 resulted in a 19.6% reduction in pruritus.
• Treatment was deemed safe with minimal adverse events.

Negative

• None.

- DMT310 achieved a PGA score of 0 or 1 for the target lesion in 29.6% of patients at Week 8 -
- DMT310 demonstrated a total PASI score of 0 or 1 for the target lesion in 25.9% of patients at Week 8 -
- DMT310 demonstrated a 19.6% reduction from baseline in pruritus at Week 8 -
- Phase 1b results support further investigation of DMT310 in psoriasis -

SAN DIEGO, CA / ACCESSWIRE / October 18, 2021 / Dermata Therapeutics, Inc. ("Dermata" or the "Company") (NASDAQ:DRMA), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced positive topline results from its Phase 1b trial of DMT310 in 30 patients as a once-weekly topical application for the treatment of mild-to-moderate psoriasis. DMT310 is Dermata's lead product candidate, with both mechanical and chemical mechanisms of action, currently being investigated to treat multiple inflammatory skin conditions, including acne, psoriasis, and rosacea.

"The objectives of our single-arm Phase 1b study of DMT310 in psoriasis were two-fold: to assess the safety and tolerability of DMT310 in psoriasis patients and to look for an efficacy signal with once-weekly treatments in mild-to-moderate psoriasis patients," said Gerry Proehl, Dermata's Chairman, President and Chief Executive Officer. "I am pleased to report that we achieved both objectives in that treatment with DMT310 appears to be safe and well tolerated by psoriasis patients, and that DMT310 demonstrated efficacy improvements in PGA, PASI, and pruritis scores for the target psoriatic lesion. Based upon the improvements witnessed across all three of our exploratory endpoints, combined with the tolerability profile observed and the continued need for safe and effective topical products for the treatment of psoriasis, we plan to continue investigation of DMT310 in psoriasis."

DMT310 Phase 1b Topline Results

• The percentage of treatment responders in Physician's Global Assessment (PGA) with a score of 0 or 1 was 29.6% at Week 8.
• The percentage of patients with a score of 0 or 1 in total Psoriasis Area Severity Index (PASI) was 25.9% at Week 8.
• Treatment with DMT310 resulted in a change from baseline in pruritis of -19.6% for the target lesion at Week 8.
• DMT310 appeared to be safe with only three reported adverse events (AEs), with only two of the three AEs evaluated as being related to treatment, and no reported serious adverse events (SAEs).
• Dermata intends to submit results from this Phase 1b study at a future medical meeting or in a publication.

"Due to the mechanical components of DMT310, we were unsure how psoriasis patients would tolerate the treatment, but after observing a majority of patients in the Phase 1b study having no tolerability issues throughout the study and only a handful of patients having mild or moderate issues, we believe that the treatment application and regimen can be further optimized to increase the treatment effect," said Christopher Nardo, Ph.D., Dermata's Senior Vice President, Development. "Importantly, the treatment effect and tolerability observed in this Phase 1b target lesion study provides support for exploring a treatment regimen with more frequent than once-weekly applications, improved application techniques, or more drug per application site, which could be more effective for moderate psoriasis patients with thicker psoriatic plaques. Therefore, we have initiated additional work in an ex vivo skin model to evaluate dosing frequency and product application to better inform the clinical trial design for a future Phase 2 psoriasis study."

DMT310 Phase 1b Trial Design

The Phase 1b study was a multi-center, open-label, single arm, proof of concept, 12-week target lesion trial designed to evaluate the safety, tolerability, and efficacy of once-weekly dosing of DMT310 in 30 patients with mild-to-moderate psoriatic plaque covering 2% to 30% of body surface area. DMT310 was applied once-weekly to a designated target lesion, with patients being assessed at 1 week, 4 weeks, 8 weeks, and 12 weeks post-application.

About DMT310

DMT310 is Dermata's lead product candidate which incorporates the proprietary, multifaceted, Spongilla technology to topically treat a variety of dermatological conditions. DMT310 is a multifactorial, naturally derived product from a unique freshwater sponge that is harvested under specific environmental conditions and then processed into a powder. The powder is mixed with a fluidizing agent immediately prior to application. DMT310's organic components contain chemical compounds that when tested in vitro, have shown a dose dependent inhibition of both IL-17A and IL-17F, which are believed to be major effector cytokines in the pathogenesis of psoriasis.

About Dermata

Dermata Therapeutics, Inc. is a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions. The Company's lead product candidate, DMT310, is the first product candidate being developed from its Spongilla technology platform. DMT310 is under clinical development for the treatment of acne, psoriasis, and rosacea. Dermata's second product candidate, DMT410, uses its Spongilla technology as a new method for topical intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin indications. 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: the potential development and commercialization of product candidate DMT310 in psoriasis; the timing of when additional studies in psoriasis may occur, if any; the design of additional studies to be conducted; whether the Phase 1b topline results of DMT310 in psoriasis will be indicative of DMT310's potential clinical outcome; the safety and tolerability profile of DMT310; and the Company's ability to obtain funding for operations, development and commercialization of DMT310. 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 and 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:
Sean Proehl
Senior Director, Legal and Business Development
info@dermatarx.com

SOURCE: Dermata Therapeutics

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FAQ

What were the key results from Dermata's Phase 1b trial of DMT310?

In the Phase 1b trial, 29.6% of patients achieved a PGA score of 0 or 1, and 25.9% achieved a PASI score of 0 or 1 at Week 8.

What percentage of patients experienced a reduction in pruritus with DMT310?

Patients experienced a 19.6% reduction in pruritus at Week 8.

Was DMT310 well tolerated in the trial?

Yes, DMT310 was reported to be safe and well tolerated, with only three adverse events reported.

What are the next steps for DMT310 after the Phase 1b results?

Dermata plans to continue investigating DMT310 for psoriasis based on the positive results from the Phase 1b trial.

What does a PGA score of 0 or 1 indicate?

A PGA score of 0 or 1 indicates that the psoriasis lesion is clear or almost clear.