Workflow
Bayer Begins Phase I/II Study on Cell Therapy for Eye Disease
BayerBayer(US:BAYRY) ZACKSยท2025-07-08 15:36

Core Insights - Bayer's subsidiary, BlueRock Therapeutics, has initiated the first patient treatment in the phase I/IIa CLARICO study with OpCT-001, an investigational iPSC-derived cell therapy for primary photoreceptor diseases [1][9] - OpCT-001 is the first iPSC-derived cell therapy tested in humans for inherited eye diseases, including retinitis pigmentosa and cone-rod dystrophy, which can cause vision loss [2][9] - The CLARICO study aims to evaluate the safety, tolerability, and clinical outcomes of OpCT-001, with a focus on safety in the phase I portion and additional safety and visual function data in the phase II part [4][9] Bayer's Stock Performance - Year-to-date, Bayer's shares have increased by 56.6%, contrasting with a 0.7% decline in the industry [7] Pipeline Developments - Bayer has expanded its pipeline to include cell therapy through the acquisition of BlueRock and gene therapy through AskBio, targeting various diseases including retinal disorders and Parkinson's disease [10] - The FDA has granted Fast Track designation to OpCT-001 for treating primary photoreceptor diseases, indicating potential for significant therapeutic advancements [11] Other Developments - Bayer is also developing bemdaneprocel (BRT-DA01) in a phase III study for Parkinson's disease, which has received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA [12]