Xyngari (DMT310) / Dermata Therap - LARVOL DELTA

BREAKING: Dermata's XYNGARI Phase 3 Trial Topline Data Meets All Primary Endpoints (PRNewswire) - P3 | N=555 | STAR-1 (NCT06090721) | Sponsor: Dermata Therapeutics | "Dermata Therapeutics, Inc...today announced positive topline results from the Company's first pivotal Phase 3 trial of XYNGARI, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. XYNGARI also appeared to be safe and well tolerated by patients with minimal treatment related adverse events and no serious adverse events attributed to treatment....In the intent to treat analysis, Dermata saw statistically significant differences in IGA treatment success, inflammatory lesion count, and non-inflammatory lesion count at Week 12 (study end) when compared to placebo....Based on these results, Dermata plans to initiate the second XYNAGRI™ Phase 3 STAR-2 trial in the second half of 2025, which will be followed by an open-label extension study."

New P3 trial • P3 data: top line • Acne Vulgaris

Dermata Announces that Last Patient Completes Last Visit in Pivotal XYNGARI Phase 3 STAR-1 Clinical Trial for Acne (PRNewswire) - "Dermata Therapeutics...announced that the last patient has completed their last visit in the Company's first pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial of XYNGARI, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. The Company remains on track to announce topline data by the end of March 2025."

Enrollment closed • P3 data: top line • Acne Vulgaris

DMT310-009 Topical in the Treatment of Acne Vulgaris (clinicaltrials.gov) - P3 | N=555 | Recruiting | Sponsor: Dermata Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2024 ➔ Mar 2025 | Trial primary completion date: Sep 2024 ➔ Jan 2025

Enrollment open • Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology

DMT310-009 Topical in the Treatment of Acne Vulgaris (clinicaltrials.gov) - P3 | N=555 | Not yet recruiting | Sponsor: Dermata Therapeutics

New P3 trial • Acne Vulgaris • Dermatology

DMT310, a Novel Once-Weekly Topical Treatment for Patients with Moderate-to-Severe Acne Vulgaris: Results of a Phase 2b Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed, J Am Acad Dermatol) - "DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater proportion of IGA treatment success at all timepoints in participants with moderate-to-severe acne."

Clinical • Journal • P2b data • Acne Vulgaris • Dermatology • Pediatrics

DMT310-005 Topical in the Treatment of Acne Rosacea (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Dermata Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2022 ➔ Dec 2022

Enrollment closed • Trial primary completion date • Acne Vulgaris • Dermatology • Rosacea

DMT310-005 Topical in the Treatment of Acne Rosacea (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Dermata Therapeutics | Trial completion date: Jun 2022 ➔ Nov 2022 | Trial primary completion date: Mar 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology • Rosacea

DMT310-005 Topical in the Treatment of Acne Rosacea (clinicaltrials.gov) - P2; N=180; Recruiting; Sponsor: Dermata Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acne Vulgaris • Dermatology • Rosacea

DMT310-005 Topical in the Treatment of Acne Rosacea (clinicaltrials.gov) - P2; N=180; Not yet recruiting; Sponsor: Dermata Therapeutics

Clinical • New P2 trial • Acne Vulgaris • Dermatology • Rosacea

Dermata Therapeutics, Inc. Announces Closing of Upsized $18.0 Million Initial Public Offering (BioSpace) - "Dermata Therapeutics, Inc...announced the closing of its previously announced initial public offering of 2,571,428 shares of its common stock and accompanying warrants to purchase up to 2,571,428 shares of common stock. Each share of common stock was sold together with one warrant to purchase one share of common stock with an exercise price of $7.00 per share at a combined offering price of $7.00, for gross proceeds of approximately $18.0 million, before deducting underwriting discounts and offering expenses....The Company intends to use substantially all of the net proceeds from the offering to advance the clinical development of DMT310 for the treatment of rosacea and psoriasis..."

Financing • Dermatology • Psoriasis

DMT310-003 Topical in the Treatment of Acne Vulgaris (clinicaltrials.gov) - P2; N=181; Completed; Sponsor: Dermata Therapeutics; Recruiting ➔ Completed

Clinical • Trial completion • Acne Vulgaris • Dermatology • Dermatopathology

DMT310-003 Topical in the Treatment of Acne Vulgaris (clinicaltrials.gov) - P2; N=180; Recruiting; Sponsor: Dermata Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open