Acne is often treated as a teenage nuisance, but for many people it behaves more like a chronic condition. About 50 million Americans deal with it each year, and roughly 10 million have moderate to severe cases. There is no cure, so most patients rely on ongoing management and repeat rounds of treatment. Sagimet Biosciences Inc. (NASDAQ: SGMT) released a full year of data suggesting its once-daily pill, denifanstat, could offer a different approach.
The drug works by blocking fatty acid synthase, or FASN, an enzyme the body uses to build certain fats. Sagimet’s view is that overactive fat production plays a part in several diseases, acne among them. According to the company, denifanstat would be the first oral acne treatment with a new mechanism of action approved in more than 40 years, if regulators sign off.
The new results come from China, where license partner Ascletis BioScience Co. Ltd. holds the rights to the drug. Ascletis presented them at the European Academy of Dermatology and Venereology Congress in Vienna. They build on an earlier 12-week trial of 480 patients that compared denifanstat with a placebo and met all of its primary and secondary goals. Afterward, 240 patients moved into an open-label extension. Of those, 116 had already been taking denifanstat and 124 had been on placebo. Everyone then received the same 50 mg daily dose, and those who stayed on the drug from the start had up to 52 weeks of treatment.
The main yardstick was treatment success. That meant a doctor rated the patient’s skin as clear or almost clear, with at least a two-point improvement on the standard scale. By the end of the study, 56.7% of patients reached that mark. Total lesion counts fell 71.8% from where they started, inflammatory lesions fell 76.9%, and non-inflammatory lesions such as blackheads and whiteheads fell 66.9%. Patients who switched over from placebo reached a 55.6% success rate, close to the 57.8% seen in those treated from day one. That suggests people who start later can catch up within the timeframe studied.
Safety was the formal focus of the extension, and the results were reassuring. No patient stopped the drug permanently because of a side effect, and there were no serious adverse events linked to denifanstat. The only treatment-related side effects above 5% were dry skin at 7.1% and dry eye at 5.9%. A few limits are worth keeping in mind. Everyone knew they were getting the drug, there was no comparison group during the extension, and the crossover patients received at most 40 weeks of treatment rather than a full year.
Those limits are why the U.S. trial matters so much. The Food and Drug Administration cleared Sagimet’s application to begin a Phase 3 study in adolescents and adults in August. Called AURORA, the trial will enroll about 800 U.S. patients aged 12 and older, including roughly 450 between the ages of 12 and 17. Patients will be randomly assigned, two to one, to denifanstat or placebo for 12 weeks. Screening is expected to begin in October, with the first patients enrolled shortly after.
The second part of the day’s news was about money. Sagimet priced an offering of 8,750,010 shares at $10.00 each, plus pre-funded warrants covering another 2,750,010 shares at $9.9999. A pre-funded warrant is essentially a share that has been paid for almost entirely up front and can be converted for a nominal $0.0001. Together, the sale is expected to bring in about $115.0 million before fees, with closing expected on October 1.
The company plans to put the money toward several things: AURORA, early work to prepare for a possible launch, a second FASN drug called TVB-3567 through Phase 2 results, and a topical FASN program headed toward a regulatory filing. Raising cash right after encouraging data is a common move in biotech. It also means existing shareholders now own a slightly smaller slice. The larger question is whether a year of steady results in China holds up in a bigger, placebo-controlled U.S. study that includes hundreds of teenagers. That is where denifanstat’s real test now begins.
