Dermira halts development of acne drug after it failed in clinical trials

March 5 (UPI) -- Dermira on Monday announced it was halting development of an acne drug after poor results in two Phase 3 trials.

The pharmaceutical company, based in Menlo Park, Calif., said in a news release a topical gel called DRM01, or olumacostat glasaretil, didn't achieve any of its endpoints when compared to an inactive control gel of participants 9 years and older with moderate to severe acne.

"We are surprised and extremely disappointed by the results of the Phase 3 program," said Tom Wiggans, chairman and chief executive officer of Dermira. "This is disappointing not only for the company, but also for patients who are living with this condition and dermatologists who have been looking for novel therapies to treat them."

Although the company is continuing to analyze the outcome of the olumacostat glasaretil Phase 3 program, "based on the information we have to date, we expect to discontinue the development program," said Luis Peña, chief development officer of Dermira. "We want to thank our employees, investigators and partners for their commitments to the acne development program and, most importantly, the patients who participated in these trials."

Acne, as the most common skin disease, affects up to 50 million Americans, according to the American Academy of Dermatology. Topical treatments and pills for the common affliction are projected to top $4 billion per year globally by 2020, according to Technavio, a market research company.

DRM01 was designed to shut down the production of sebum, which is the oily, waxy matter excreted by tiny glands in the skin, according to STAT.

The twin Dermira clinical trials enrolled 1,500 adolescents and adults with moderate to severe acne, randomizing them to twice-daily treatment with DRM01 or an inactive control for 12 weeks.

In the two tests of 1,500 adolescents, the company found that reductions in the numbers of inflammatory and non-inflammatory lesions from baseline to week 12, as well as a two-grade improvement after 12 weeks, were statistically insignificant. Side effects, they note, were mild to moderate in severity.

"We remain dedicated to bringing new treatments to people living with chronic, underserved skin conditions. As we look ahead, we are focused on building a commercial organization to support the anticipated launch of glycopyrronium tosylate for axillary hyperhidrosis later this year, subject to FDA approval, as well as our Phase 2b trial evaluating lebrikizumab as a potential treatment for moderate-to-severe atopic dermatitis, for which we expect to announce topline data in the first half of 2019," Wiggans said.

Hyperhidrosis is also known as excessive sweating.

Stock prices on NASDAQ plunged 70 percent in premarket trading Monday after the announcement.