Longeveron Announces Achievement of Surpassing 50% Enrollment Threshold in Phase 2 ELPIS II Study of Lomecel-B™ in Hypoplastic Left Heart Syndrome

Rhea-AI Summary

Longeveron Inc. announced that the Phase 2 ELPIS II trial for the treatment of HLHS has surpassed the 50% enrollment threshold. An additional study location has been activated to expedite enrollment completion. A webinar will be held to discuss the potential of Lomecel-B™ in improving outcomes for HLHS patients.

Positive

• The Phase 2 ELPIS II trial for HLHS has surpassed the 50% enrollment threshold
• An additional study location has been activated to expedite enrollment completion
• Lomecel-B™ has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the FDA

Negative

• None.

Company Activates Additional Study Location to Expedite Enrollment Completion

Key Opinion Leader Webinar Highlighting the Potential for Lomecel-B™ in the Treatment of HLHS to be held Wednesday, August 16, 2023 at 10:00 AM ET

MIAMI, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, announced today the Phase 2 ELPIS II trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) and using the Company’s Lomecel-B™ asset in Hypoplastic Left Heart Syndrome (HLHS), has surpassed the 50% enrollment threshold. Additionally, the trial has activated its eighth clinical site location – one additional site beyond the seven originally planned -- in order to try to expedite the completion of the trial enrollment.

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow (blood circulation throughout the body), which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. While these children can now live into adulthood, early mortality is still extremely high in this population due to right ventricle failure, which is not meant for the increased load demanded by the systemic circulation. As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes.

“Surpassing the 50% enrollment threshold is a significant milestone for the trial and more importantly for HLHS patients who are in such critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We look forward to continuing to execute on our clinical program for Lomecel-B™ and to do all possible to expedite completing enrollment in the ELPIS II trial.”

Key Opinion Leader Webinar to be Held Wednesday, August 16, 2023 at 10:00 AM ET

Longeveron will host a virtual webinar to discuss the unmet medical need and current standard of care for patients suffering from HLHS, as well as the potential of medicinal signaling cells, such as those making up Lomecel-B™ for injection, in improving outcome for these patients. The event will feature Sunjay Kaushal, MD, PhD and Ram Kumar Subramanyan, MD, PhD.

For more information and to register for the event, click here.

ELPIS II (NCT04925024) is a 38-participant, randomized (1:1) blinded, controlled Phase 2 clinical trial evaluating 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 previously received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA). ELPIS II is being funded by grants from the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI; Grant numbers UG3HL148318, U24HL148316), in collaboration with Longeveron.

Note: the content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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 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 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.

Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 14, 2023 and its Quarterly Report on Form 10-Q for the first quarter of 2023 filed with the SEC on May 12, 2023. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com

FAQ

What is the Phase 2 ELPIS II trial?

The Phase 2 ELPIS II trial is evaluating the safety and efficacy of Lomecel-B™ in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery.

What is HLHS?

HLHS is a congenital birth defect in which the left ventricle of the heart is severely underdeveloped or missing.

What is Lomecel-B™?

Lomecel-B™ is a cellular therapy being developed by Longeveron for the treatment of HLHS.

What designations has Lomecel-B™ received from the FDA?

Lomecel-B™ has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the FDA.

What is the purpose of the webinar?

The webinar will discuss the unmet medical need for HLHS patients and the potential of Lomecel-B™ in improving outcomes for these patients.