– FDA designation enables expedited clinical development and regulatory review timelines for Lomecel-B™ –

– Second designation received for Lomecel-B™ for the treatment of mild Alzheimer’s Disease after Regenerative Medicine Advanced Therapeutics (RMAT) Designation announced on July 9, 2024 –

Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Lomecel-B™ for the treatment of mild Alzheimer’s Disease. Lomecel-B™ is a proprietary, scalable, allogeneic, investigational cellular 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 ongoing).

“Fast Track designation is another important milestone for Longeveron and Lomecel-B™, which, along with the recent granting of Regenerative Medicine Advanced Therapy (RMAT) designation, recognizes the critical need to quickly advance novel, safe and effective investigational treatments for Alzheimer’s Disease, which has a devastating impact on patients and their families,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “Alzheimer’s Disease is a neurodegenerative disorder that leads to progressive memory loss and death, and its tremendous impact on our aging population is exacerbated by a lack of therapeutic options that slow disease progression or improve cognitive function. We believe that Lomecel-B™, which demonstrated an overall slowing/prevention of disease worsening compared to placebo in the CLEAR MIND Phase 2a clinical trial, has the potential to become an important treatment option for physicians and patients, and we look forward to sharing the latest data with the Alzheimer’s Disease research and patient communities at AAIC 2024.”

The FDA’s Fast Track designation process is designed to facilitate the development and expedite the review of new therapies intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Investigational therapies that receive Fast Track designation may be eligible for Priority Review if relevant criteria are met at the time of application submission to FDA, and rolling FDA review.

The Fast Track designation granted to the Lomecel-B™ Alzheimer’s Disease program is the fifth special regulatory designation received for Lomecel-B™. The Lomecel-B™ Alzheimer’s Disease program has also been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, while the Lomecel-B™ HLHS program has received three FDA designations: Orphan Drug designation, Fast Track designation and Rare Pediatric Disease designation.

Source: https://investors.longeveron.com/news/News/news-details/2024/Longeveron-Announces-U.S.-FDA-Grants-Fast-Track-Designation-for-Lomecel-B-for-the-Treatment-of-Mild-Alzheimers-Disease/default.aspx