SUMITOMO PHARMA CO LTD

Vibegron Shows Sustained Long-Term Safety and Efficacy for Men with OAB and BPH

21 days ago

• New data from the COURAGE Phase 3 open-label extension study demonstrates vibegron 75 mg maintains safety and efficacy for up to 52 weeks in men with overactive bladder symptoms receiving treatment for benign prostatic hyperplasia. • Improvements in key efficacy outcomes including micturitions, urgency episodes, and nocturia were sustained throughout the 52-week treatment period, with no new safety signals compared to previous studies. • Vibegron became the first beta-3 agonist approved for treating OAB symptoms in men on BPH therapy in December 2024, addressing an important unmet need in this patient population.

Major Pipeline Expansion in Schizophrenia Treatment: 55+ Companies Developing 60+ Novel Therapies

4 months ago

• DelveInsight's latest pipeline report reveals over 55 pharmaceutical companies actively developing 60+ innovative drug candidates for schizophrenia treatment, indicating significant industry investment in addressing this serious mental illness. • Several promising candidates are advancing in clinical trials, including Lyndra's weekly oral risperidone (LYN-005), AbbVie's selective M4 receptor PAM emraclidine, and Kynexis's cognitive function-targeting KYN-5356. • Multiple clinical trials are scheduled for early 2025, including LB-102 for acute schizophrenia, Click Therapeutics' digital therapeutics, and Cerevel's emraclidine safety study, demonstrating diverse therapeutic approaches.

BlueRock Therapeutics' Bemdaneprocel Advances to Phase 3 for Parkinson's Disease

4 months ago

• BlueRock Therapeutics is initiating a Phase 3 trial, exPDite-2, for bemdaneprocel, a cell therapy for Parkinson's disease, expected to begin in the first half of 2025. • The exPDite-2 trial will enroll 102 patients with moderate Parkinson's, assessing the change in 'on' time without dyskinesia over 78 weeks compared to a sham surgery. • Bemdaneprocel aims to replace dopamine-producing neurons lost in Parkinson's, with Phase 1 data showing tolerability and encouraging trends in motor function. • The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation, potentially accelerating its development and review process.

AI-Designed Drug for Alzheimer's Psychosis Enters Clinical Trials

5 months ago

• Exscientia and Sumitomo Dainippon Pharma's AI-designed drug, DSP-0038, has entered Phase 1 trials for Alzheimer's disease psychosis. • DSP-0038 selectively targets serotonin 5-HT2A and 5-HT1A receptors, potentially reducing side effects compared to traditional antipsychotics. • Exscientia's AI platform, Centaur Chemist, accelerates drug discovery by efficiently identifying promising molecules for testing. • This marks Exscientia's third AI-derived compound to reach clinical trials, highlighting the potential of AI in pharmaceutical R&D.

FDA Approves Gemtesa (Vibegron) for Overactive Bladder in Men with BPH

5 months ago

• The FDA has approved Gemtesa (vibegron) for men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). • Gemtesa is the first and only beta-3 adrenergic receptor agonist approved for OAB in men being treated for BPH, addressing a significant unmet need. • Approval was based on a Phase 3 trial demonstrating significant reductions in micturition and urgency episodes compared to placebo. • Common adverse reactions in the trial included hypertension and urinary tract infections, with a similar rate of serious adverse events to placebo.

Endometriosis Research Faces Funding Hurdles Despite Affecting 10% of Women Globally

5 months ago

• Despite affecting approximately 10% of women worldwide, endometriosis research remains severely underfunded, with only two new drugs approved in recent years for pain management. • Women's health research has historically suffered from data gaps due to historical exclusion from clinical trials, leading to limited understanding of diseases like endometriosis and fewer treatment options. • Recent initiatives including a $100 million Biden administration investment in women's health research signal potential progress, though experts emphasize the need for non-hormonal treatment approaches.

FDA Accepts Sumitomo Pharma's sNDA for Vibegron in Men with OAB and BPH

a year ago

• The FDA has accepted Sumitomo Pharma's sNDA for vibegron (GEMTESA) to treat OAB symptoms in men receiving BPH pharmacological therapy. • The sNDA is based on Phase 3 trial results showing statistically significant reductions in daily micturition and urgency episodes with vibegron. • If approved, vibegron will be the first beta-3 agonist for OAB in men undergoing BPH treatment, addressing a significant unmet need. • The FDA's target action date for the decision on vibegron's approval is set for Q3 of FY2024 under the PDUFA.

Imeglimin's Impact on Glycemic Control and Erythrocytes in Type 2 Diabetes: INFINITY Study

2 years ago

• The INFINITY study investigates imeglimin's effects on glycemic control markers and erythrocytes in type 2 diabetes patients over six months. • Researchers will compare HbA1c, glycoalbumin (GA), and 1,5-anhydroglucitol (1,5-AG) to assess imeglimin's glucose-lowering effect and potential impact on erythrocyte lifespan. • The study will also evaluate imeglimin's influence on erythrocyte deformability and its potential to improve peripheral arterial disease, a complication of type 2 diabetes. • This single-arm, open-label trial aims to determine if HbA1c accurately reflects imeglimin's efficacy and explore the drug's broader effects on erythrocyte function.