Aclipse Therapeutics Partners with Mayo Clinic for Phase 2 Trial of First Disease-Modifying Gastroparesis Treatment
核心洞察
Aclipse Therapeutics (搜索) has entered a clinical collaboration with Mayo Clinic to advance M107 (lobeglitazone), positioned as the first potential disease-modifying treatment for gastroparesis (搜索).
The Phase 2 LOGAST trial will begin enrollment in Q1 2026 across three Mayo Clinic campuses, targeting patients with idiopathic gastroparesis (搜索).
M107 works by targeting macrophage-driven inflammation, shifting harmful pro-inflammatory M1 macrophages (搜索) toward anti-inflammatory M2 macrophages (搜索) to address underlying disease biology.
Aclipse Therapeutics (搜索) has entered a clinical collaboration with Mayo Clinic to advance a Phase 2 study of M107, a novel small-molecule drug positioned as the first potential disease-modifying treatment for gastroparesis (搜索), a chronic condition marked by stomach paralysis and severely delayed gastric emptying.
Under the agreement, Aclipse will provide research support while Mayo Clinic leads the upcoming investigation, known as the LOGAST trial. Enrollment is expected to begin in the first quarter of 2026 and will span three Mayo Clinic campuses in Minnesota, Arizona, and Florida, involving roughly 10 clinical investigators.
Novel Mechanism Targets Disease Biology
Gastroparesis (搜索), which disrupts signals between the stomach's muscles and nerves, has long lacked therapies that address its underlying biology. M107 targets macrophage-driven inflammation — a mechanism increasingly linked to the disease — by shifting harmful pro-inflammatory M1 macrophages (搜索) toward anti-inflammatory M2 macrophages (搜索). Aclipse said this dual action highlights the drug's potential to modify disease progression rather than simply manage symptoms.
M107 is the active ingredient lobeglitazone, which was originally developed by Chong Kun Dang (搜索) as the diabetes (搜索) drug Duvie and was licensed globally to Aclipse in 2023 for the development of new indications. Aclipse confirmed that lobeglitazone is an orally administered small molecule drug with anti-inflammatory effects and an excellent clinical safety profile.
Addressing Significant Unmet Medical Need
Gastroparesis (搜索) is a condition in which the emptying of food from the stomach is delayed in the absence of mechanical obstruction. More than half of gastroparesis patients are in a severe or worse condition, and it is known that two-thirds of patients are dissatisfied with current treatments. However, there are no drugs that fundamentally treat the disease, resulting in significant unmet medical needs.
The trial will be led by Dr. Pankaj Jay Pasricha, chair of internal medicine at Mayo Clinic Arizona, and will evaluate M107 in patients with idiopathic gastroparesis (搜索). The study is investigator-initiated and sponsored by Mayo Clinic.
Industry Leadership Perspectives
Raymond K. Houck, Aclipse Therapeutics (搜索)' chief executive officer, said the collaboration reflects a joint commitment to delivering new options for a patient population with limited treatments. He described M107 as an oral candidate with a favorable safety profile and anti-inflammatory benefits that directly address macrophage dysregulation in gastroparesis (搜索).
"Collaboration with the Mayo Clinic is a critical step in offering new treatment possibilities to patients with gastroparesis (搜索), a serious and chronic disease," Houck stated. "Through this study, Aclipse expects M107 to become the first oral therapy capable of fundamentally addressing the pathophysiology of gastroparesis, and we will further strengthen our clinical development strategy in cooperation with Chong Kun Dang (搜索)."
Kim Youngjoo, CEO of Chong Kun Dang (搜索), said, "Aclipse's collaboration with the Mayo Clinic marks a meaningful advancement in Chong Kun Dang's strategy to expand Duvie (lobeglitazone) beyond diabetes (搜索) into new therapeutic areas. We plan to continue working closely with Aclipse to provide innovative treatment options."
Mayo Clinic noted that it holds a financial interest in the technology referenced in the collaboration and will use any revenue generated to support its not-for-profit mission in patient care, education, and research.
If successful, M107 would represent a rare breakthrough in a field where current therapies focus primarily on symptom management rather than disease modification — a gap that has left many patients with persistent, debilitating gastrointestinal dysfunction.