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Acute pancreatitis stem cell therapy (SCM-AGH) of SCM Life Science (KOSDAQ 298060 CEO Lee Byung-gun, hereinafter SCM Life Science), a company specializing in cell therapy, has been designated as a rare drug in the development stage by the Ministry of Food and Drug Safety (hereinafter referred to as the Ministry of Food and Drug Safety). In other words, a window of hope has opened for patients suffering from acute pancreatitis, which has yet to have no medicine, and their families to relieve the pain faster.

SCM Life Science announced on the 7th that its stem cell treatment SCM-AGH has been designated by the Ministry of Food and medicine Safety as a rare medicine in the development stage under the Advanced Regenerative Medicine and Advanced Bio-medicine Safety and Support Act. The target indication is severe acute pancreatitis accompanied by organ failure of Computerized Tomography Severity Index (CTSI) 7-10.

Through this designation of rare medicine, SCM Life Science is expected to gain momentum in the development of SCM-AGH, an acute pancreatitis stem cell treatment. The pipeline is currently undergoing phase 2a clinical trials. Usually, drugs require enormous capital and time to proceed with phase 3 clinical trials after phase 2.

However, SCM-AGH is expected to be able to obtain conditional product approval around 2024 based on the results of phase 2b clinical trials prior to phase 3 clinical trials through this designation of rare medicine. Furthermore, as SCM-AGH is designated as a rare medicine, it is expected that it will be possible to apply for designation of a target for rapid treatment that takes precedence over other drugs.

Earlier, the government implemented the Advanced Biopharmaceuticals Act on August 28 to support the development of advanced biopharmaceuticals. The Advanced Rehabilitation Act contains a wide range of support for rare drugs, such as screening rare drugs before other drugs and granting conditional marketing after phase 2 clinical trials.

SCM Life Science had previously been designated as a rare medicine in the development stage for SCM-CGH, a stem cell treatment for Graft versus host disease, which is currently in phase 2 clinical trials in 2019.

Above all, it is said that the possibility of faster healing has been opened for patients with acute pancreatitis suffering from the designation of rare medicine. Acute pancreatitis is a fatal disease with a mortality rate of 15% after the outbreak, but no treatment has been developed yet.

SCM-AGH is a cell therapy with a freeze-type formulation under development by SCM Life Science. Currently, indications are expanding to acute pancreatitis, atopic dermatitis, and acute dyspnea syndrome. Last month, SCM Life Science applied to the Ministry of Food and Drug Safety for a phase 2a clinical trial plan (IND) for patients with moderate or higher acute dyspnea syndrome of the same pipeline.

An SCM life science official said, "The designation of SCM-AGH, an acute pancreatitis treatment drug, is the 29th of the drugs being developed in Korea," adding, "It is important to ensure early treatment of patients suffering from rare diseases.