Sagimet Biosciences NASDAQ: SGMT plans to begin a Phase III study of its oral fatty acid synthase, or FASN, inhibitor denifanstat in moderate-to-severe acne within the next several months, following positive results from a China-based Phase III trial conducted by partner Ascletis, company executives said during a Canaccord Genuity discussion.
Chief Executive Officer David Happel said Sagimet is a clinical-stage biopharmaceutical company focused on conditions associated with overexpression or overactivity of FASN. The company’s programs include acne, liver disease and certain tumors that depend on FASN for disease progression.
Denifanstat is designed to address de novo lipogenesis, or fat accumulation, Happel said. In acne, the process contributes to excess sebum production, inflammation, bacterial load and hyperkeratinization, or plugging of the skin. He said denifanstat directly targets sebum and inflammation, the two primary drivers the company is pursuing in acne treatment.
Phase III Acne Program
Chief Medical Officer Andreas Grauer said Ascletis’ Phase III trial in China enrolled 480 patients with moderate-to-severe acne, randomized one-to-one between active treatment and placebo. Patients had investigator global assessment, or IGA, scores of 3 to 4 and substantial inflammatory and non-inflammatory lesion counts at baseline.
The trial met its two primary endpoints, according to Grauer, showing statistically significant results for IGA success and reduction in inflammatory lesions. It also showed significant reductions in non-inflammatory lesions. He said IGA success improved by about 20 percentage points over placebo.
Grauer characterized the safety profile as positive. Dry eye was reported in a little more than 10% of treated patients, compared with 9% of placebo patients, while dry skin was reported in approximately 6% of treated patients versus 2% on placebo. He said the company did not observe Grade 3 or serious adverse events in the study.
Sagimet’s planned U.S. Phase III study will enroll 800 patients with moderate-to-severe acne, including 450 adolescents ages 12 to 17. The study will use a 2:1 randomization, intended to provide at least 300 adolescents receiving the drug, as requested by the Food and Drug Administration, Grauer said.
The primary analysis will occur at 12 weeks and will assess three endpoints: success on the Evaluator’s Global Severity Score, or EGSS, inflammatory lesion reduction and non-inflammatory lesion reduction. Grauer said the patient population and overall design will be similar to the Ascletis study.
Happel said the company has an open investigational new drug application and has received a “study may proceed” determination from the FDA. Sagimet expects to dose its first patient within the next couple of months, with last-patient, last-dose anticipated around this time next year and topline data shortly afterward.
Market and Pipeline Plans
Happel said approximately 50 million Americans have acne, with about 20% categorized as having moderate-to-severe disease. He said fewer than half of the estimated 10 million to 15 million U.S. patients in that category currently receive prescription treatment.
Current prescription treatment commonly includes oral antibiotics and topical therapies, he said. Isotretinoin, commonly known by the former brand name Accutane, is generally reserved for a smaller group of patients with severe nodular inflammatory lesions because of its toxicity profile.
According to Happel, patients with moderate-to-severe disease can also have truncal, or torso, acne, which may be difficult to address with topical products typically applied to the face and neck. He said Sagimet believes an oral systemic treatment with a favorable safety and tolerability profile could have an important role in this population.
The company has not provided formal pricing guidance. However, Happel said early payer research conducted after Ascletis’ Phase II data suggested payers were receptive to the treatment profile. He noted that sarecycline, an oral antibiotic approved for acne, is priced at roughly $1,000 to $1,200 per month, while two recently introduced topical products were also priced near $1,000 per month.
Sagimet expects Ascletis to present 52-week open-label extension data at a European dermatology meeting next month. Happel said the data are expected to show continued improvement in treatment response alongside the previously observed safety and tolerability profile.
Beyond denifanstat, Sagimet plans to begin a Phase II study of a second oral FASN inhibitor at the end of the year after completing Phase I work. The company expects Phase II data next year. It is also developing a topical FASN inhibitor intended to expand treatment to patients with milder acne, with first-in-human studies planned for early 2028.
About Sagimet Biosciences (NASDAQ:SGMT)
Sagimet Biosciences NASDAQ: SGMT is a clinical-stage biotechnology company focused on developing novel therapies for fibrotic diseases. The company's lead program, CM-101, is a first-in-class fusion protein designed to neutralize the chemokine CCL24 and interrupt key drivers of tissue fibrosis. Preclinical data have demonstrated CM-101's potential to block fibrotic signaling pathways in multiple organ systems, and the company has advanced the program into early-stage clinical evaluation for indications such as nonalcoholic steatohepatitis and systemic sclerosis.
In addition to CM-101, Sagimet maintains a pipeline of preclinical candidates targeting inflammation-driven fibrotic processes.
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