Roche has set its sights on Hanmi Pharmaceutical’s obesity drug candidate HM17321, intrigued by promising preclinical results suggesting simultaneous weight loss and muscle preservation. This novel approach, utilizing a non-incretin mechanism unlike existing obesity treatments, could potentially reduce weight while maintaining lean body mass and even improving muscle function.
On Thursday, U.S. biotech news outlet Fierce Biotech reported an interview with Dr. Manu Chakrabarti, Roche’s head of cardiovascular, renal, and metabolic disease development, who shed light on why Roche is particularly interested in HM17321’s preclinical results.
HM17321, developed in-house by Hanmi Pharmaceutical, is a long-acting urocortin 2 (UCN2) analog. It operates through a non-incretin mechanism, selectively activating the corticotropin-releasing factor 2 (CRF2) receptor, setting it apart from traditional GLP-1 class drugs.
In his interview with Fierce Biotech, Dr. Chakrabarti emphasized that the preclinical data clearly demonstrated the potential for weight reduction while preserving lean body mass through this non-incretin mechanism. He highlighted Roche’s particular interest in the possibility of not only maintaining muscle mass during weight loss but also enhancing muscle function.
This aligns seamlessly with Roche’s strategy to expand the scope of obesity treatment beyond mere weight loss to encompass improvements in body composition and overall metabolic health.
Dr. Chakrabarti stressed the importance of addressing lean body mass loss during weight reduction, especially for elderly patients or those at high risk of falls and fractures. He pointed out a significant unmet need for treatments that can promote weight loss while safeguarding muscle mass.
Another promising aspect of HM17321 is its potential to enhance insulin sensitivity. Roche is keenly interested in the possibility of not only facilitating weight loss but also expanding treatment options for various obesity-related metabolic disorders by improving insulin resistance.
Last month, Hanmi Pharmaceutical inked an exclusive licensing agreement for HM17321 with Genentech. The deal grants Genentech worldwide rights to develop, manufacture, and commercialize HM17321, excluding South Korea. Hanmi received an upfront payment of 190 million USD, with the total contract value potentially reaching 2.3 billion USD, including milestone payments for development, approval, and commercialization.
Hanmi Pharmaceutical is currently conducting Phase 1 clinical trials for HM17321. Once completed, Genentech will take over the reins, proceeding with Phase 2 trials. Dr. Chakrabarti expressed Genentech’s eagerness to initiate Phase 2 as swiftly as possible.
However, Roche cautioned that the potential of HM17321 has not yet been clinically confirmed. Dr. Chakrabarti noted that preclinical results don’t always translate directly to human subjects, emphasizing the need to await clinical data.
HM17321’s significance extends beyond its potential efficacy; it represents the addition of a novel mechanism to Roche’s existing portfolio of obesity treatments.
Roche’s current obesity treatment pipeline includes GLP-1 and GIP dual agonists, oral GLP-1 treatments, amylin analogs, and FGF21 class therapies. With HM17321, the company has secured a new obesity treatment strategy through a non-incretin approach.
The UCN2 mechanism isn’t entirely new to the pharmaceutical landscape. Eli Lilly previously explored it for heart failure treatment but halted development during Phase 1 clinical trials in 2019.
Roche’s current agreement has piqued industry interest as it attempts to repurpose the relatively underdeveloped UCN2 mechanism for obesity treatment.