Terns Pharmaceuticals unveiled early-phase weight loss data from an oral GLP-1 agonist that it says could be more tolerable at higher doses than currently marketed GLP-1 drugs administered the same way.
In the multiple ascending dose portion of Terns’ Phase 1 trial, 67% of patients taking the highest 740 mg daily dose of TERN-601 lost at least 5% of their body weight at 28 days. The dose also achieved a placebo-adjusted mean weight reduction of 4.9% (p<0.0001). The weight loss data were split by dose group with no pooled analysis of the treatment cohort. The study enrolled overweight and obese adults with a BMI of at least 27 kg/m2 and less than 40 kg/m2.
For context, Novo Nordisk’s semaglutide was linked with around 2% weight loss at four weeks in the registrational STEP 1 trial, although weight loss increased to 16% at 68 weeks. As for Eli Lilly’s tirzepatide, the 15 mg dose achieved an average of 2% weight loss at four weeks in the SURPASS-2 study compared to semaglutide. Overall weight loss went up to 13% at 40 weeks. Both therapies are injections.
Terns’ share price was up around 7% premarket Monday after the announcement.
Safety-wise, TERN-601 was well-tolerated, with no dose interruptions, reductions or discontinuations at any dose, according to a release. There were no severe or serious side effects observed. The company said it plans to present these data at an upcoming scientific conference.
In the release, CMO Emil Kuriakose added that Terns has “identified an optimal range of clinically active, well-tolerated doses” to advance to Phase 2 development, which is set to begin next year.
The Foster City, CA-based biotech said its drug has several “distinct properties” that could set it apart from other GLP-1 agonists. These include low solubility and high permeability in the gut, which can facilitate sustained action on the drug target and a more consistent pharmacokinetic profile. Furthermore, only a small amount of the drug circulates freely in the body, which may translate to improved tolerability at higher doses when combined with the PK advantage, the company said.
With the readout, the company joined the ranks of several other drugmakers in advancing a new round of weight loss drugs with differentiated profiles.
Lilly’s retatrutide, a treatment that targets GLP-1, GIP and glucagon, seems to trigger greater weight loss than some marketed drugs, according to Phase 2 data.
Meanwhile, Amgen is touting the potential for improved maintenance of weight loss with MariTide, which activates the GLP-1 receptor while blocking the GIP receptor. In June, Altimmune released a full Phase 2 analysis of its GLP-1/glucagon dual receptor agonist, pemvidutide, which it says could be better at preserving lean muscle mass.