FOSTER CITY, Calif. - Terns Pharmaceuticals, Inc. (NASDAQ:TERN), a clinical-stage biopharmaceutical company, today revealed positive top-line results from its Phase 1 trial for TERN-601, a potential obesity treatment. The study, involving healthy adults with obesity or overweight, demonstrated a statistically significant placebo-adjusted mean weight loss of 4.9% over 28 days at the highest dose tested.
The trial, which was randomized, double-blind, and placebo-controlled, assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily dosing of TERN-601. The highest dose of 740 mg resulted in 67% of participants experiencing a weight reduction of at least 5% from their baseline body weight.
TERN-601 was well-tolerated with no treatment-related dose interruptions, reductions, or discontinuations, even with rapid dose titration. Most adverse events were mild, with gastrointestinal events consistent with the GLP-1R agonist class and no clinically significant changes in liver enzymes, vital signs, or electrocardiograms.
The promising results have positioned TERN-601 as a potential leading GLP-1R agonist, due to its efficacy, tolerability, and manufacturing scalability. Terns Pharmaceuticals plans to initiate Phase 2 clinical trials in 2025.
The company's CEO, Amy Burroughs, stated that these findings validate the potential of TERN-601 as a monotherapy or in combination with other agents for treating obesity. Chief Medical Officer Emil Kuriakose highlighted the optimal dose range identified for Phase 2 trials, which is expected to be well tolerated based on the Phase 1 data.
Terns Pharmaceuticals aims to present the detailed data from this trial at an upcoming scientific conference and has announced a conference call for investors today to discuss these findings.
This report is based on a press release statement from Terns Pharmaceuticals. The information presented is intended for investor consideration and does not constitute an endorsement of TERN-601's efficacy or safety. Further studies will be necessary to confirm these results and determine the long-term potential of TERN-601 as an obesity treatment.
In other recent news, Terns Pharmaceuticals reported strong earnings and revenue results, with both TD Cowen and Mizuho Securities maintaining positive ratings on the company's shares. The company is eagerly awaiting the interim Phase 1/2 CARDINAL study data for chronic myeloid leukemia (CML), expected in 2025. Analysts note the potential convenience of the once-daily dosing of the company's treatment, which does not require food intake.
The company also announced the appointment of Elona Kogan as its new chief legal officer, a strategic move that supports the company's development and pipeline advancement. Terns Pharmaceuticals has further demonstrated its operational stability by securing the extension of its office lease in Foster City, California, through 2027.
Recent developments also include progress in the ongoing Phase 1 study of TERN-701. Interim findings suggest the drug can be administered once daily with or without food. The forthcoming Phase 1 data for another of Terns' drugs, TERN-601—an oral GLP-1 receptor agonist for obesity—is expected next month, highlighting the company's commitment to innovative therapies. These are among the recent developments at Terns Pharmaceuticals.
InvestingPro Insights
Amidst the promising clinical trial results for TERN-601, Terns Pharmaceuticals' financial outlook presents a mixed picture. According to InvestingPro data, Terns Pharmaceuticals holds a market capitalization of $549.6 million, reflecting investor recognition of its potential in the biopharmaceutical landscape. However, the company's P/E ratio stands at -5.96, indicating that it does not generate net earnings at the moment, which is consistent with many clinical-stage biopharmaceutical companies.
Investors should note that Terns Pharmaceuticals does not currently pay a dividend, as the company likely reinvests all available funds into its research and development efforts. A noteworthy InvestingPro Tip is that Terns has more cash than debt on its balance sheet, providing a level of financial stability as it continues to invest in its pipeline of treatments.
Another InvestingPro Tip to consider is that five analysts have revised their earnings upwards for the upcoming period, suggesting increased confidence in the company's future financial performance. This optimism may be tied to the potential market for obesity treatments and the promising results of TERN-601.
For those interested in a deeper analysis, there are additional InvestingPro Tips available, offering a more comprehensive understanding of Terns Pharmaceuticals' financial health and market position.
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