StemRIM Inc. announced that a clinical trial plan for Phase 2 investigator-initiated clinical trial, targeting ischemic cardiomyopathy using Redasemtide, has been submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) by Osaka University. Redasemtide is a drug under development that has been licensed out to Shionogi & Co. Ltd. This clinical trial will be initiated with the submission of this clinical trial plan notification.

This clinical trial will be conducted as an investigator-initiated clinical trials at Osaka University Hospital and several other facilities. The main objective of this clinical trial is to evaluate the efficacy and safety of Redasemtide in patients with ischemic cardiomyopath who have undergone coronary artery bypass grafting. This clinical trial will evaluate various cardiac function tests such as echocardiography at 52 weeks after treatment with either Redasemtide or placebo (10 patients each) for 5 days.

Redasemtide are a completely new concept in medicine that induces functional regeneration of organs and tissues damaged by injury or disease. The ectodermal mesenchymal stem cells induced by administration of Redasemtide can differentiate into diverse tissues and are expected to be effective in a variety of disease areas, including ischemic cardiomyiology. Furthermore, as it is administered through intravenous infusion and does not involve the use of live cells, this pharmaceutical product is industrially producible.

Unlike traditional regenerative medical products that utilize live cells, it avoids quality control issues during manufacturing and product transport. It is anticipated to have a cost advantage and widespread adoption due to its simple administration method. In clinical trials to date, the safety and efficacy of Redasemtide have been confirmed in dystrophic epidermolysis bullosa (add additional Phase 2 clinical trial ongoing at Osaka University Hospital and other institutions), acute ischemic stroke (global Phase 2b clinical trial ongoing in Japan, the United States, and Europe), knee osteoarthritis (Phase 2 investigator-initiatedclinical trial completed at Hirosaki University Hospital), and chronic liver disease (Phase 2 investigator-in initiated clinical trial l completed at Niigata University Medical and Dental Hospital).

Ischemic cardiomyopathy will be the 5th indication for Redasemtide in a Phase 2 clinical trial. The impact on the financial performance for the fiscal year ending July 31, 2024, is nothing. Nevertheless, believe it contributes to the medium to long-term improvement of overall performance.