Sagimet’s Denifanstat produced a 57% treatment-success rate after up to 52 weeks.
- Total acne lesions fell 72% and inflammatory lesions declined 77% in a Phase 3 extension study in China.
- Its Phase 3 study in the U.S. is expected to enroll about 800 patients aged 12 and older.
- Sagimet is raising $115 million at $10 per share, a 7% premium over Tuesday’s close.
Shares of Sagimet Biosciences (SGMT) rose 13% in pre-market trading on Wednesday after the biotech firm reported promising long-term results for its experimental acne drug and raised fresh capital to fund its upcoming U.S. Phase 3 trial.
Sagimet’s Denifanstat produced a 57% treatment-success rate after up to 52 weeks, while total acne lesions fell 72% and inflammatory lesions declined 77% in a Phase 3 extension study in China conducted by Sagimet’s licensing partner, Ascletis.
Denifanstat is a once-daily oral drug that blocks fatty acid synthase (FASN), an enzyme that causes acne. The drug was generally well tolerated, with no patients permanently stopping treatment because of adverse events.
U.S. Phase 3 Trial To Involve 800 Patients
The results come as Sagimet prepares to begin screening patients in October for its Phase 3 study in the U.S. The trial is expected to enroll about 800 patients aged 12 and older, including roughly 450 adolescents.
Patients will receive either Denifanstat or placebo for 12 weeks, with around 530 patients eligible to continue into a 40-week extension study. Sagimet said Denifanstat could potentially become the first oral acne treatment with a new mechanism of action approved in more than 40 years.
Sagimet Raises $115 Million To Fund Phase 3
To fund its U.S. study, Sagimet announced that it is raising $115 million at $10 per share, along with pre-funded warrants. This represents a 7% premium over Tuesday’s close.
Beyond funding the Phase 3 trial and a potential drug launch, the proceeds will also support TVB-3567, its other acne drug in development, through Phase 2 results and advance its topical FASN inhibitor program toward an Investigational New Drug (IND) application.
Sagimet reported $257.6 million in cash, cash equivalents and marketable securities as of June 30, which the company expects would fund operations through 2028.
Retail’s Take On SGMT
Retail sentiment surrounding SGMT on Stocktwits remained ‘extremely bullish’ over the past 24 hours amid ‘high’ message volumes. SGMT was also among the top trending tickers at the time of writing.
The stock has seen significant buying interest so far this year, gaining 56%.
Also read: Redwire Joins Growing Orbital Data Center Race With Sophia Days After $980M Space Force Contract Selection
For updates and corrections, email newsroom[at]stocktwits[dot]com<