Chong Kun Dang said on the 27th that its global partner, Aclipse Therapeutics, signed an agreement with the Mayo Clinic for a phase 2 clinical trial of the gastroparesis treatment candidate "M107 (lobeglitazone)."
Lobeglitazone is the active ingredient in Duvie, a diabetes drug independently developed by Chong Kun Dang. In 2023, Chong Kun Dang signed a global license agreement with Aclipse to develop new indications, and the clinical research to expand the indication (therapeutic area) to gastroparesis has gained momentum.
Under the agreement, the Mayo Clinic will conduct an investigator-initiated clinical trial of M107 funded by Aclipse's research grant.
The phase 2 trial, named LOGAST, will begin recruiting participants in the first quarter of next year and will be conducted at the three Mayo Clinic campuses in Rochester, Minnesota; Phoenix, Arizona; and Jacksonville, Florida.
According to Aclipse, lobeglitazone is a small-molecule drug that can be developed as an oral medication, with anti-inflammatory effects and clinically strong safety. The company judged that by increasing the expression of M2 macrophages, which suppress inflammation, and reducing M1 macrophages, which cause inflammation—thereby correcting macrophage imbalance—it has high potential as a treatment for gastroparesis.
Gastroparesis is a disease in which gastric emptying of food is delayed without mechanical obstruction. More than half of patients present with severe or worse conditions, and there is a large unmet medical need because there are no drugs that fundamentally treat the disease.
Raymond K. Houk, Aclipse chief executive officer (CEO), said, "Collaboration with the Mayo Clinic is an important step in presenting new treatment possibilities for patients with gastroparesis, a serious and chronic disease," adding, "Through this study, we expect M107 to become the first oral therapy capable of modulating the fundamental pathophysiology of gastroparesis."
Kim Young-ju, Chong Kun Dang CEO, said, "Aclipse's collaboration with the Mayo Clinic is a meaningful step forward in Chong Kun Dang's strategy to expand Duvie (lobeglitazone) into new therapeutic areas beyond diabetes," adding, "We plan to continue working closely with Aclipse to provide innovative treatment options."