– Expects to enroll first patient in Phase 2 clinical trial of Lomecel-B™ for Aging-Related Frailty in Japan in 1Q23 –
– Extended cash runway into 2H24 –
MIAMI, Jan. 06, 2023 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today provided a corporate update highlighting the Company’s strategic priorities and anticipated milestones for 2023.
“This past year Longeveron made robust progress advancing our lead investigational product Lomecel-B™ in multiple indications, achieving key regulatory and clinical development milestones across our programs,” said Chris Min, M.D., Ph.D., Longeveron’s Interim Chief Executive Officer and Chief Medical Officer. “In the first quarter, we look forward to enrolling the first patient in our Phase 2 Aging-Related Frailty trial in Japan, where we believe we are in a strong position to help deliver a much-needed therapy to the country’s aging population. In 2023, we will focus our Aging-Related Frailty efforts in Japan, while continuing to build on our progress in HLHS and Alzheimer’s Disease. Additionally, we have extended our cash runway into the second half of 2024, placing us in a strong position to execute on our corporate objectives.”
2023 Pipeline Updates and Anticipated Milestones
- Hypoplastic Left Heart Syndrome (HLHS): The ELPIS II trial continues to enroll at 7 clinical sites.
- ELPIS II is a Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-B™ in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery.
- Lomecel-B™ for HLHS has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA). Longeveron expects to publish the full data from the Phase 1 ELPIS I trial in a peer-reviewed publication in 1Q23. Top-line data from ELPIS I were previously announced in 2021.
- Aging-Related Frailty: Longeveron expects to enroll the first patient in the Company’s Phase 2 clinical trial of Lomecel-B™ for Aging-Related Frailty in Japan.
- The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind single-infusion study of two different dose levels of Lomecel- B™. The primary objective of the study is to evaluate the safety of Lomecel-B™ as a treatment for Aging-Related Frailty. The trial is expected to enroll 45 patients. The Phase 2 trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG; Nagoya) and Juntendo University Hospital (Tokyo) and the clinical sites have been activated and patients are being screened for participation.
- After consultation with the United States Food and Drug Administration (FDA), Longeveron may advance a parallel program in the United States. In the near-term, Longeveron is focusing its Aging-Related Frailty resources on clinical development in Japan.
- Alzheimer’s Disease: In November 2022, Longeveron announced the completion of enrollment in a Phase 2a trial of Lomecel-B™ in patients with mild Alzheimer’s Disease (AD). Longeveron expects to release topline data from the Phase 2a trial in early 2024.
- The Phase 2a trial is a clinical trial of Lomecel-B™ designed to evaluate the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild AD.
- Longeveron ended 2022 with approximately $20 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated expenses and capital expenditure requirements into the second half of 2024.
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™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple mechanisms of action encompassing pro-vascular, pro-regenerative, and anti-inflammatory, promoting tissue repair and healing with broad potential applications across a spectrum of disease areas. Longeveron is advancing Lomecel-B™ through clinical trials in three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer’s Disease, and Aging-Related Frailty. Additional information about the Company is available at www.longeveron.com.
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Source: Longeveron Inc