Phase 3 data of mdc-IRM first product based on MedinCell’s technology, shows significant improvements in patients with schizophrenia
Phase 3 data of mdc-IRM, first product based on MedinCell’s technology, shows significant improvements in patients with schizophrenia
• Prolonged time to impending relapse
• Decreased risk of relapse
• Increased chance of clinical stability
Developed in collaboration with Teva Pharmaceuticals, mdc-IRM, a risperidone extended-release injectable suspension for the treatment of patients with schizophrenia (Teva codename: TV-46000), is the most advanced investigational product based on MedinCell’s BEPO® technology. Ongoing New Drug Application review by FDA could lead to commercialization as early as 2022 in the U.S. by Teva, provided marketing authorization. MedinCell is eligible for development and commercial milestones ($122 million), and royalties on net sales.
MedinCell’s partner, Teva Pharmaceuticals, announced results from the pivotal Phase 3 Risperidone Subcutaneous Extended-release (RISE) study comparing TV-46000 once monthly (q1m) and TV-46000 once every two months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone. Results showed treatment with TV-46000 (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. The safety profile of TV-46000 is favourable, with no new safety signals versus existing data for both oral and other long-acting formulations of risperidone. These findings, amongst others, were presented during the poster session at the 2021 Psych Congress Annual Meeting taking place Oct. 29-Nov. 1, 2021 in San Antonio, TX.
“Supported by the unveiling of this pivotal data by our partner, mdc-IRM demonstrates significant potential in reducing the risk of relapse and in stabilizing clinical symptoms, both of which are key to improving the management of this burdensome disease,” said Christophe Douat, CEO of MedinCell. “These findings further strengthen our belief that our long-acting technology could positively impact the adoption of long-acting injectables, and notably for mdc-IRM, patients with first-episode psychosis and early-stage schizophrenia.”
Schizophrenia is a chronic and severe mental disorder1 characterized by distortions in thinking, perception, emotions, language, sense of self and behavior.2 Twenty million people worldwide are affected by schizophrenia1, often living with considerable disability.2 Currently, about 70% of people living with schizophrenia are not receiving appropriate care3 despite the treatability of the illness.2
Efficacy and Safety of Subcutaneous Risperidone Injectable (TV-46000) in Patients With Schizophrenia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study (RISE Study)
The Phase 3 RISE was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 13-65 years) with schizophrenia. 544 patients were randomized to receive a subcutaneous injection of TV-46000 once monthly (q1m), once every two months (q2m), or placebo in a 1:1:1 ratio (stage 2). The study was designed to compare
TV-46000 q1m and TV-46000 q2m with placebo in patients with schizophrenia who underwent stabilization on oral risperidone (stage 1). The primary endpoint was time to impending relapse and secondary endpoints included proportions of patients with impending relapse at week 24 and proportions of patients who maintained stability at week 24. No new safety signals were identified with TV-46000 versus accumulated safety data of oral risperidone and other long-acting risperidone formulations.
Out of 1267 patients screened, 863 were enrolled and 544 were randomized. Time to impending relapse significantly favored TV-46000 (hazard ratio [95% CI]; overall: 0.283 [0.184, 0.435], P<.0001; q1m: 0.200 [0.109, 0.367], P<.0001; q2m: 0.375 [0.227, 0.618], P<.0001) versus placebo. TV-46000 also prolonged time to relapse by 3.5, 5.0 and 2.7 times, respectively, versus placebo. Proportions of patients with impending relapse at week 24 were significantly lower for TV 46000 (overall: 9%; q1m: 7%; q2m: 11%) versus placebo (28%; P<.0001, P<.0001, P=.0001, respectively). Proportions of patients maintaining stability were significantly higher (83%, 87%, 80% vs 61%; P<.0001, P<.0001, P=.0001, respectively). The safety profile of TV-46000, as observed in this study, is consistent with other formulations of risperidone. The most common adverse reactions (≥5% and greater than placebo) were nasopharyngitis, increased weight, and extrapyramidal disorder.
1 – GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. [published correction appears in Lancet. 2019 Jun 22;393 (10910):e44]. Lancet. 2018;392 (10159): 1789-1858.
2 – World Health Organization. Schizophrenia. www.who.int/news-room/fact-sheets/detail/schizophrenia. Accessed on October 4, 2021.
3 – Lora A, et al. Service availability and utilization and treatment gap for schizophrenic disorders: a survey in 50 low- and middle-income countries. Bulletin of the World Health Organization. 90 (1), 47-54B. World Health Organization. http://dx.doi.org/10.2471/BLT.11.089284