Expanding into a broad range of diseases through the regenerative-inducing medicine platform

「The additional Phase II investigator-initiated clinical trial in dystrophic epidermolysis bullosa has now been completed, the global late Phase II trial in acute ischemic stroke has ended, the Phase II investigator-initiated clinical trial in ischemic cardiomyopathy is under way, and the Phase II investigator-initiated clinical trials in osteoarthritis of the knee and chronic liver disease have been completed.」

「The common regenerative-inducing medicine® platform is expected to provide broad therapeutic benefits across diverse diseases, including central nervous system diseases such as cerebral infarction, head trauma, amyotrophic lateral sclerosis (ALS) and spinal cord injury; cardiovascular diseases such as myocardial infarction and cardiomyopathy; epithelial diseases such as refractory skin ulcers; gastrointestinal diseases such as chronic liver disease and ulcerative colitis; skeletal diseases such as refractory fractures and cartilage injuries; and respiratory diseases such as pulmonary fibrosis.」

「The common regenerative-inducing medicine® platform is expected to provide broad therapeutic benefits across diverse diseases, including central nervous system diseases such as cerebral infarction, head trauma, amyotrophic lateral sclerosis (ALS) and spinal cord injury; cardiovascular diseases such as myocardial infarction and cardiomyopathy; epithelial diseases such as refractory skin ulcers; gastrointestinal diseases such as chronic liver disease and ulcerative colitis; skeletal diseases such as refractory fractures and cartilage injuries; and respiratory diseases such as pulmonary fibrosis.」

「Against this backdrop, we believe that delivering regenerative-inducing medicines® to patients worldwide suffering from a range of diseases, including intractable diseases such as epidermolysis bullosa, as an innovative regenerative-medicine technology designed to overcome the many challenges associated with transplantation and conventional regenerative medicine, represents StemRIM’s social mission.」

「Since March 2024, an investigator-initiated Phase II clinical trial has been under way at multiple institutions, led by Osaka University Hospital.」

「StemRIM believes that its social mission is to deliver regenerative-inducing medicines to patients worldwide suffering from a wide range of diseases, including intractable diseases such as epidermolysis bullosa. These medicines achieve regenerative medicine by inducing the accumulation of mesenchymal stem cells within the patient's own body through drug administration, without using cells cultured and processed outside the body, and represent an innovative regenerative medicine technology that overcomes many of the challenges associated with transplantation and conventional regenerative medicine.」

「Based on the favorable results of this trial, Shionogi & Co.,Ltd. began a global late-stage Phase II clinical trial in Japan on 10 April 2023, in the United States on 28 April 2023, and in Europe and China on 25 July 2023. Clinical trials are also planned in 20 countries worldwide.」

「Based on the favorable results of this trial, Shionogi & Co.,Ltd. began a global late-stage Phase II clinical trial in Japan on 10 April 2023 and in the United States on 28 April 2023. In Europe, a CTR (Clinical Trial Application) was submitted on 31 March 2023, and the clinical trial is scheduled to begin shortly. Clinical trials are also planned in 20 countries worldwide, including China.」

「Regarding development of the treatment for knee osteoarthritis (PJ1-04), we were notified that the investigator-initiated Phase II clinical trial conducted at Hirosaki University had achieved its primary endpoint in March 2023.」

「StemRIM believes that its social mission is to deliver regenerative-inducing medicines to patients worldwide suffering from a wide range of diseases, including intractable diseases such as epidermolysis bullosa. These medicines achieve regenerative medicine by inducing the accumulation of mesenchymal stem cells within the patient's own body through drug administration, without using cells cultured and processed outside the body, and represent an innovative regenerative medicine technology that overcomes many of the challenges associated with transplantation and conventional regenerative medicine.」

「For cerebral infarction (PJ1-02), the efficacy of redasemtide was confirmed in the Phase II trial, and preparations are currently under way for a global Phase III trial. Phase II clinical trials are under way for knee osteoarthritis (PJ1-04) and chronic liver disease (PJ1-05). For myocardial infarction/cardiomyopathy (PJ1-03), preparations are under way at Osaka University to begin a clinical trial equivalent to a Phase II trial.」

「Since November 2020, an investigator-initiated Phase II clinical trial in patients with chronic liver disease has been conducted at Niigata University, and patient enrollment was completed in June 2022. Data analysis and evaluation are scheduled to follow a 6-month follow-up period.」

「Based on the favorable results of this trial, Shionogi & Co.,Ltd. plans to prepare for the transition to a global Phase III clinical trial.」

「We believe that delivering regenerative-inducing medicines to patients worldwide suffering from a range of diseases, including intractable diseases such as epidermolysis bullosa, as an innovative regenerative-medicine technology designed to overcome the many challenges associated with transplantation and conventional regenerative medicine, represents StemRIM’s social mission.」

「In addition to advancing these development programs, we recognize that expanding into further indications, advancing development of follow-on pipeline programs and identifying new development candidates are essential goals for enhancing corporate value and stabilizing management. To achieve these goals, we will promote joint research and business alliances and implement measures such as installing equipment to establish a more robust research and development structure.」

「We will continue to accelerate initiatives aimed at maximizing the value of redasemtide through expansion into a broad range of disease areas.」

「Phase II clinical trials for chronic liver disease and knee osteoarthritis began in November 2020. We will continue to accelerate initiatives aimed at maximizing the value of redasemtide through expansion into a broad range of disease areas.」

「This agreement involves preparing to launch investigator-initiated clinical trials for chronic liver disease, knee osteoarthritis and cardiomyopathy, using the nonclinical evidence accumulated through joint research with several academic groups. We will continue to accelerate initiatives aimed at maximizing the value of redasemtide through expansion into a broad range of disease areas.」

「The common regenerative-inducing medicine platform is expected to provide broad therapeutic benefits across diverse diseases, including central nervous system diseases such as cerebral infarction, head trauma, amyotrophic lateral sclerosis (ALS) and spinal cord injury; cardiovascular diseases such as myocardial infarction and cardiomyopathy; epithelial diseases such as refractory skin ulcers; gastrointestinal diseases such as chronic liver disease and ulcerative colitis; skeletal diseases such as refractory fractures and cartilage injuries; and respiratory diseases such as pulmonary fibrosis.」

「In addition, in June 2020 we opened the Collaborative Research Institute for Regenerative Induction Medicine, with 1,540 m² of floor space in an existing facility on Osaka University’s campus, securing a new research base capable of supporting the expanding research operations that represent the most important management issue in realizing our medium- to long-term growth strategy. The institute will further accelerate advanced evaluation research on new regenerative-inducing medicine candidates and specialized development research aimed at expanding indications to a diverse range of target diseases, enabling a significant acceleration in expanding indications from comprehensive searches for regenerative-inducing medicine candidates.」

「The opening of this collaborative research institute will further accelerate advanced evaluation research on new regenerative-inducing medicine candidates and specialized development research aimed at expanding indications to a diverse range of target diseases, enabling a significant acceleration in expanding indications from comprehensive searches for regenerative-inducing medicine candidates.」

「Pharmacological effects, including suppression of functional impairment, have been confirmed in several target diseases, and we are pursuing research and development toward realizing regenerative-inducing medicines.」

「The common regenerative-inducing medicine platform is expected to provide broad therapeutic benefits across numerous intractable diseases involving tissue damage, including central nervous system diseases such as cerebral infarction and spinal cord injury, cardiovascular diseases such as myocardial infarction and cardiomyopathy, epithelial diseases such as refractory skin ulcers, and mesenchymal diseases such as refractory fractures.」