Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotech company aiming to address life-threatening and chronic aging-related conditions using cell therapies, continues to make positive progress. The company just reported positive top-line results from its phase 2a trial of Lomecel-B™, its investigational product, for the treatment of mild Alzheimer’s disease.
In the trial of 48 patients ages 60 to 85 years old with mild Alzheimer’s disease, Lomecel-B™ met its primary safety endpoint and also showed statistically significant evidence of slowing disease progression as compared to placebo.
“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B™ in the treatment of Alzheimer’s disease and provide a robust foundation for additional clinical trials in this and other indications,” Wa’el Hashad, Chief Executive Officer of Longeveron, said when announcing the phase 2a trial results. “We look forward to announcing additional biomarker data from this trial which may further characterize the clinical effects of Lomecel-B™ in this study population.”
Targeting Neurodegeneration And Inflammation
Lomecel-B™ is made from medical signaling cells (MSCs) derived from the bone marrow of young, healthy adult donors. It is believed that MSCs travel to sites of damage or inflammation in the body and may promote cellular regeneration.
The promising results of its phase 2a trial come as the world reaches an inflection point with Alzheimer’s disease. About 6.7 million people ages 65 and older in the U.S. suffer from the disease. It’s only expected to get worse as the population continues to age. By 2060, it has been projected that Alzheimer’s disease may affect 14 million people in the U.S.
Lomecel-B™’s Potential For Other Conditions?
That’s not the only opportunity for Longeveron and Lomecel-B™. The experimental therapeutic treatment is also in phase 2 trials to treat Hypoplastic Left Heart Syndrome (HLHS) and Aging-related Frailty.
HLHS is a rare congenital heart defect in which the left side of the heart fails to develop, leading to short-term mortality, delayed development and long-term organ failure. HLHS affects about 1,000 babies in the U.S. annually and requires a three-stage open-heart surgery to survive, and even with the surgeries, early mortality and need for heart transplantation are still extremely high due to right ventricle failure. As a result, there is an important unmet medical need to improve right ventricular function in these patients – and that’s where Lomecel-B™ may potentially be effective.
Administered directly into the cardiac tissue of the right ventricle during the second stage of the surgery – when the child is around four months old – the goal is to improve right ventricular function through the potential regenerative, pro-vascular and anti-inflammatory effects of MSCs. Results from Longeveron’s phase 1 ELPIS 1 trial showed 100% survival in Lomecel-B™ treated patients for up to five years. Based on the results achieved to date, Lomecel-B™ has received Rare Pediatric Disease Designation (RPD), Orphan Drug Designation (ODD), and Fast Track designation from the United States Food and Drug Administration (FDA). Longeveron’s 38-patient phase 2 trial is currently underway. In August, the trial passed the 50% enrollment threshold. To expedite the completion of the trial enrollment, an additional clinical site was also added.
Aging – A Growing Problem
Lomecel-B™ is also in phase 2 trial to treat Aging-related Frailty , which is characterized by mobility disability, weakness, fatigue, weight loss, slowness and low activity. People with Aging-related Frailty are also more prone to develop infections, suffer from falls and require hospitalization. There are no approved treatments for Aging-related Frailty, but Longeveron hopes that its experimental product may gain approval as a potential treatment. Lomecel-B™ is currently being tested in a phase 2 trial of 45 patients in Japan, where nearly a third of the population is over the age of 65.
In a previous phase 2b trial, a single intravenous (IV) infusion of Lomecel-B™ was shown to improve walking distance during a six-minute walk test after nine months. If greenlighted, Lomecel-B™ could become the first FDA-approved treatment in the U.S. for Aging-related Frailty, addressing an unmet need that appears likely to increase as the population ages.
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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, the anticipated use of proceeds from the offering, as well as 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; market and other conditions; 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 Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the third quarter of 2023 filed with the SEC on November 9, 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.
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