Longeveron (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(TM) for the treatment of mild Alzheimer’s disease. To the company’s knowledge based on publicly available information, Lomecel-B, a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer’s. “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.”
To view the full press release, visit https://ibn.fm/tuqXb
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The company’s lead investigational product is Lomecel-B(TM), an allogeneic medicinal signaling cell (“MSC”) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (“HLHS”), Alzheimer’s disease, and Aging-related Frailty. The Lomecel-B HLHS program has received three separate and distinct FDA designations: Orphan Drug, Fast Track and Rare Pediatric Disease designations. For more information about the company, visit www.Longeveron.com.
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