Terns Pharmaceuticals will advance TERN-601 into Phase II after early-stage data showed the oral therapy led to weight loss of 4.9%, comparable with weight loss pills Lilly and Pfizer are developing, according to analysts.
Terns Pharmaceuticals’ oral GLP-1R agonist led to mean weight loss of nearly 5% after just 28 days when compared to placebo during an early-stage trial, sending the biotech’s shares climbing over 18% in early-morning trading Monday.
BMO Capital Markets analysts called the data “compelling” in a Monday morning note. BMO compared the Phase I results for TERN-601 to oral competitors such as Eli Lilly’s orforglipron, which has achieved 3.9% weight loss in a similar study, and Pfizer’s danuglipron, which led to 5.2% weight loss.
The Phase I study featured adult patients who have obesity or are overweight across three doses. The 4.9% placebo-adjusted mean weight loss was achieved in the highest dose arm of TERN-601, which patients received once daily, according to a Monday press release. Terns also said that 67% of participants in this group lost 5% or more of their baseline body weight.
“With operational preparations well underway, we look forward to swiftly advancing this promising product candidate into Phase II clinical development in 2025,” Terns CEO Amy Burroughs said in the announcement.
TERN-601 was well-tolerated with no treatment-related dose interruptions, reductions or discontinuations, the company noted. Gastrointestinal events were mild to moderate and consistent with the wider class of GLP-1R agonists. Terns also reported that there were no clinically meaningful changes in liver enzymes.
“These compelling results underscore TERN-601’s potential to be a class-leading GLP-1R agonist based on its composite profile of initial indications of efficacy, tolerability and manufacturing scalability,” said Burroughs.
Terns’ oral therapy has an edge in the oral weight-loss drug space because it is dosed once daily, which has been difficult for some competitors, BMO noted. Pfizer discontinued twice-daily dosing of danuglipron in December 2023 after high discontinuation rates. The drug was revived in July with a once-daily regimen. Lilly’s orforglipron is being tested with a once-daily dose.
“TERN-601’s profile, in our view, supports advancement as a monotherapy or in combinations,” BMO wrote.
Terns could look within its pipeline for such a combination to TERN-501 or TERN-800, BMO noted.
Data from the TERN-601 Phase I trial will be presented at a future medical meeting.
