ImmunoForge Doses First Patient in Phase 2 Clinical Trial of Froniglutide for Dermatomyositis/Polymyositis

ImmunoForge today announced that it has dosed the first patient in its Phase 2 clinical trial to evaluate the efficacy, safety, and pharmacokinetic properties of Froniglutide in patients with dermatomyositis/polymyositis.

Dermatomyositis/polymyositis (DM/PM) is a disease characterized by muscle wasting and muscle weakness that severely impairs quality of life and is currently treated with steroids and immunosuppressive drugs that have many side effects, indicating a significant unmet need for effective therapies.

Froniglutide is a weekly GLP-1 receptor agonist biotherapeutic designed to increase muscle mass and strength by directly acting on muscle cells through targeting GLP-1 receptors that are overexpressed in the muscles of patients with DM/PM. It is expected to improve quality of life in DM/PM patients by restoring muscle strength, improving extra-muscular symptoms such as rash, difficulty swallowing, dyspnea, and fever, and to reduce inflammation. There are currently no drugs in development with the same mechanism of action and no therapies that directly act on the muscle.

"Froniglutide has a proven safety profile and a unique mechanism of action that directly affects muscle cells, and we look forward to seeing its clinical efficacy demonstrated in patients," said Dr. Dae-Hyun Yoo, a professor of rheumatology at Hanyang University, who is the principal investigator of the Phase 2 study. The clinical study is currently enrolling patients at 10 university hospitals in South Korea, including Hanyang University Hospital.

ImmunoForge Co. Ltd., a biotechnology company focused on developing new drugs for rare and intractable diseases, has received orphan drug designation from the U.S. FDA for polymyositis and dermatomyositis and developmental orphan drug designation from the South Korean regulatory agency, the Ministry of Food and Drug Safety (MFDS), and holds composition of matter patents and method of use patents for Froniglutide in the treatment of muscle myositis and sarcopenia. Separately, we have received Phase 2 clinical trial approval from the U.S. FDA for Duchenne muscular dystrophy, another potential indication for Froniglutide, and are pursuing joint development. In May, we announced plans to complete a listing on KOSDAQ in 2025 based on our achievements, including completing technology transfer to a global pharmaceutical company for another new drug based on our ELP half-life extension platform technology.

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