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Longeveron® Announces U.S. FDA Grants Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer’s Disease
- Lomecel-B™ appears to be the first cellular therapeutic candidate to receive RMAT designation for Alzheimer’s Disease MIAMI, July 10, 2024 (GLOBE NEWSWIRE)
About this update from Longeveron Inc.
[{"type":"text","content":"- Lomecel-B™ appears to be the first cellular therapeutic candidate to receive RMAT designation for Alzheimer’s Disease\nMIAMI, July 10, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for certain life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for the treatment of mild Alzheimer’s Disease. Lomecel-B™ is a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimer’s Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-B™ is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer’s Disease. “The RMAT designation is an important milestone for Longeveron and the Lomecel-B™ program that recognizes the potential of our cellular therapy to have a positive impact on patients afflicted with this devastating disease,” said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. “Alzheimer’s Disease is a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. In the CLEAR MIND Phase 2a clinical trial, Lomecel-B™ demonstrated an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B™ groups compared to placebo.” Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results on December 20, 2023. Full study results for CLEAR MIND will be reported in a Featured Research Oral Presentation at the 2024 Alzheimer’s Association International Conference (AAIC) on July 28, 2024. “We are thrilled to receive the RMAT designation for Lomecel-B™ for the treatment of mild Alzheimer’s Disease and we look forward to meeting with the F...