CT-868

BERKELEY, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Carmot Therapeutics Inc. (Carmot), a clinical-stage biotechnology company dedicated to developing life-changing therapeutics for people living with metabolic diseases including obesity and diabetes, today announced that its acquisition by the Roche Group (Roche) has been completed. Having successfully completed its acquisition of Carmot, Roche obtains access to Carmot’s current R&D portfolio including all clinical and pre-clinical assets, as well as exclusive access to Carmot’s innovative Chemotype Evolution discovery platform in metabolism, further strengthening Roche’s R&D efforts and portfolio across cardiovascular and metabolic diseases. Carmot and its employees will join the Roche Group as part of Roche’s Pharmaceuticals Division. The acquisition gives Roche access to Carmot’s differentiated portfolio of incretins including: CT-388, the lead asset, is a Phase-2 ready, dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes. Injected subcutaneously once a week, it has potential as a standalone and combination therapy to improve weight loss and to be expanded to other indications.CT-996, a once-daily oral, small molecule GLP-1 receptor agonist currently in Phase-1 intended to treat obesity in patients with and without type 2 diabetes.CT-868, a Phase-2, once-daily subcutaneous injectable, dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients with overweight or obesity. Financial Considerations Roche has acquired all outstanding shares and options of Carmot at a purchase price of $2.7 billion. Carmot’s equity holders are additionally entitled to receive payments of up to $400 million depending on the achievement of certain milestones. About Obesity Obesity is one of the most pervasive health challenges in the world and an area where recent scientific advances can help meet the high unmet medical need. This condition is associated with many health challenges and comorbidities, including type 2 diabetes, cardiovascular diseases, fatty liver, and chronic kidney disease, which together place an incredible strain on healthcare systems worldwide. Over 4 billion people are estimated to be obese or overweight by 2035, approaching 50% of the world’s population.1 Scientific advances in the field of incretins and an increased understanding of relevant disease biology have significantly changed the possibilities to treat obesity over the last years. Incretins are gut hormones that are secreted after food intake and play a role in modulating blood glucose by stimulating insulin secretion. Emerging scientific data show a wider biologic effect of incretins in multiple organs including the liver, heart and brain, suggesting they may have broader roles in the body. Incretins are clinically validated targets and the emerging standard of care therapies in obesity and could also be effective targets in other disease areas. About Carmot TherapeuticsCarmot Therapeutics is a clinical-stage biotechnology company dedicated to developing life-changing therapeutics for people living with metabolic diseases, including obesity and diabetes. Carmot’s expertise in metabolic biology has enabled the development of a broad pipeline of therapeutics, including three clinical candidates: CT-388 (once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist), CT-996 (once-daily oral, small molecule GLP-1 receptor agonist) and CT-868 (once-daily subcutaneous injectable, dual GLP-1/GIP receptor agonist) and other molecules in preclinical development. All of these are proprietary novel compounds, wholly owned by Carmot, that have the potential to deliver an enhanced treatment response in people with metabolic diseases. For more information, visit the Carmot Therapeutics website. References1 World Obesity Atlas 2023, https://data.worldobesity.org/publications/WOF-Obesity-Atlas-V5.pdf

The drug’s safety profile was similar to its previous trials and no new safety signals were observed. Innovent is gearing up to push into the China obesity market as the company announces a phase 3 win for mazdutide, a molecule from Eli Lilly’s deep bench of obesity assets. China-based Innovent secured the rights to the dual GLP-1/glucagon receptor agonist from Lilly in 2019 for an undisclosed sum. A phase 2 readout in May raised expectations, linking a 9 mg dose of the molecule to placebo-adjusted weight loss of 15.4% after 24 weeks. Now, the company has published results that it has claimed show the drug is “the first GLP-1R/GCGR dual agonist succeeding in phase 3 trials.” A total of 610 participants received either 4 mg or 6 mg dose of mazdutide or placebo during the 48 week study. The trial, dubbed GLORY-1, hit both of its primary endpoints, showing superiority to placebo when it came to reducing body weight by week 32 as well as the proportion of participants with a weight loss of 5% or more. The “weight-loss efficacy was further improved from week 32 to week 48,” the company noted. The trial also aced its secondary endpoints, which included the proportion of participants who saw a weight loss of 10% and above, alongside changes in waist circumference, systolic blood pressure, triglycerides and low-density lipoprotein cholesterol, to name a few. “Mazdutide demonstrated superiority to placebo in all the above weight loss and cardiometabolic endpoints,” Innovent said. The drug’s safety profile was similar to its previous trials and no new safety signals were observed. The company didn’t offer a deeper look at its efficacy data in the release—although it did reference plans to publish the full results in the future—but Innovent sounded confident it has what it needs to pitch to Chinese regulators. “The results of the GLORY-1 study show that mazdutide has strong weight loss efficacy with favorable safety and tolerability,” Lei Qian, Vice President of Clinical Development at Innovent, said in the Jan. 8 release. “We are further preparing the results and plan to submit the first NDA of mazdutide for weight management in the near term,” he added. “We are also developing mazdutide for other indications on the basis of scientific evidence and unmet medical needs. Innovent will continue to strategically build our next-generation product pipeline in the cardiovascular and metabolic field, and help people's pursuit of a healthy life.” While GLORY-1 is focused on 4 mg and 6 mg doses, Innovent has also just launched another phase 3 obesity study called GLORY-2 that is assessing a 9 mg dose. This dose level was identified in the phase 2 update back in the spring as being “favorable.” Innovent isn’t the only one eyeing up the 160 million-strong obesity market in China. Lilly completed a China phase 3 trial of tirzepatide—now sold as Mounjaro in the U.S. for diabetes and as Zepbound for obesity—in late 2022. Meanwhile, Novo Nordisk won a China approval for semaglutide in 2021, although, with the authorization only covering diabetes, use in obesity is just off-label in the country for now. Lilly has the rights to develop mazdutide outside of China and continues to list the candidate in its phase 1 pipeline. However, with tirzepatide setting the bar high—weight loss after 24 weeks was similar to Innovent’s phase 2 results—and mazdutide one of two next-generation weight loss products in Lilly’s pipeline, it is unclear how far the Big Pharma will take the program.