Dermata Therapeutics' rosacea ambitions are in the red after the company’s lead asset failed a phase 2 trial, placing additional pressure on the med as an acne treatment.
The company delved into few details in a Monday announcement, but Chief Development Officer Christopher Nardo, Ph.D., pointed to high dropout and placebo response rates as reasons for why DMT310 was unable to significantly reduce skin bumps compared to placebo. The dropout rate was 23% among treated patients, 10 percentage points higher than the dropout rate among acne patients treated with the same med in a previous trial, Nardo said.
He added that 36% of treatment patients responded, compared to 23% in those receiving placebo. The company reported a 44% reduction in lesions, similar to data seen in a previous acne trial.
But critical details were left out, including the reasons for the dropouts among trial participants and more robust safety data. The incidence of adverse events was listed as the secondary endpoint on the company’s clinical trial record.
While Dermata is not ready to officially call it quits on the indication, CEO Gerry Proehl said that “efforts and resources” would be directed toward the acne program.
The company's shares, which were already trading at just 64 cents heading into Monday, had fallen more than 61% shortly after the market opened, down to 25 cents apiece.
2023 is gearing up to be a critical year, with Dermata hoping to schedule an end-of-phase 2 meeting with the FDA regarding the severe acne pathway in the first half of 2023. The biotech plans to launch a phase 3 study in 2023 as well. In June 2020, Dermata released phase 2b data showing that its once-weekly treatment helped reduce inflammatory lesions and acne severity at weeks four, eight and 12 following treatment.
But money is dwindling. Dermata had $8.1 million in cash compared to nearly $11 million when 2022 began as of the end of September. In an attempt to add capital and minimize costs, the company is looking for a partner on runner-up asset DMT410, which is being developed for excessive sweating and aesthetics. Proehl said during the company’s third-quarter earnings report that it looks forward to “continued partnering discussions.”