- Longeveron recently released its full-year results for the period ended December 31, 2023, and provided a corporate update
- The update outlined the company’s plans to prioritize the development of Lomecel-B(TM) in Hypoplastic Left Heart Syndrome (“HLHS”), a rare, pediatric congenital heart condition characterized by an underdeveloped left side of the heart
- Longeveron plans to complete the enrollment in the ELPIS II trial for HLHS in 2024
- The company also reported that it is exploring opportunities to advance its Alzheimer’s disease program through potential partnerships or other sources of funding
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing regenerative medicine for life-threatening conditions with unmet medical needs, recently released its full-year results for the period ended December 31, 2023, and provided a corporate update (https://ibn.fm/iORBu). Results from multiple studies using Longeveron’s lead investigational therapeutic candidate, Lomecel-B(TM), were announced by the company last year.
“In 2023 we made significant strides advancing studies of our investigational product, Lomecel-B(TM), in Hypoplastic Left Heart Syndrome (“HLHS”) and Alzheimer’s disease, with long-term survival data from ELPIS I trial presented at the American Heart Association (‘AHA’) annual meeting and clinically meaningful results announced from our Phase 2a CLEAR MIND clinical trial of Lomecel-B(TM) in the treatment of mild Alzheimer’s disease,” said Longeveron CEO Wa’el Hashad.
The ELPIS I trial was an open-label Phase 1 study designed to investigate the safety and potential efficacy of the intramyocardial injection of Lomecel-B(TM) administered to 10 infants with HLHS during the Glenn procedure, the second of three open-heart surgeries performed to correct HLHS, at about 4-5 months of age. (HLHS is a congenital condition characterized by the underdevelopment of the left side of the heart.) The final results from the study, announced in September 2021, showed that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected rate of growth one year after treatment (https://ibn.fm/nTsZs).
Nonetheless, after ELPIS I came to its planned end, investigators elected to extend the follow-up of the 10 infants for a total period of five years. It is the data from this ongoing extended long-term follow-up that the company presented as a poster at the 2023 annual AHA meeting. The company also summarized this data in its recent corporate update, noting that children in the ELPIS I trial had 100% transplant-free survival up to five years of age after receiving Lomecel-B(TM) compared to about 20% mortality rate observed from historical control data. This data, the update continued, reinforces the potential survival benefit of Lomecel-B(TM) for patients with HLHS.
The update also emphasized Longeveron’s prioritization of the development of Lomecel-B(TM) in HLHS. “For 2024 our main strategic priority will be focused on our lead clinical program in HLHS, our most important near-term value driver. Accordingly, we made the strategic decision to discontinue our Phase 2 clinical program in Aging-related Frailty in Japan,” explained Hashad.
The company is expecting to complete enrollment in the ELPIS II trial, a Phase 2 controlled clinical trial, in the fourth quarter of calendar 2024. (The company announced in August last year that it had surpassed 50% enrollment threshold) (https://ibn.fm/eBxKN). To achieve this target, Longeveron plans to implement additional measures that the company’s management outlined during the conference call that accompanied the release of the financial results (https://ibn.fm/vVij1).
For instance, Longeveron is in the process of activating new sites to add to its existing seven sites. Additionally, the company is working with advocacy groups to increase awareness among patients and is planning to hold an investigator meeting during which the company intends to take additional measure with the goal of expediting study enrollment.
“We are also exploring opportunities to advance our Alzheimer’s disease program through potential partnerships or other sources of funding. These steps will allow us to focus our available resources on completing enrollment in our follow-on ELPIS II study in 2024. HLHS patients are in critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication,” Hashad continued.
Longeveron’s focus on its Alzheimer’s disease program comes on the back of positive results from the Phase 2a CLEAR MIND trial of Lomecel-B(TM) for the treatment of mild Alzheimer’s disease. According to the corporate update, the study met its primary safety and secondary endpoints. These results, Longeveron stated, support the therapeutic potential of Lomecel-B(TM) in treating mild Alzheimer’s disease and provide evidence-based support for potential further clinical development.
Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com
For more information, visit the company’s website at www.Longeveron.com.
NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at http://ibn.fm/LGVN
