Longeveron Announces Completion of Enrollment in Phase 2a Trial of Lomecel-BTM for the Treatment of Alzheimer’s Disease
Miami, Florida—November 10, 2022— Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced the completion of enrollment in its Phase 2a trial of Lomecel-BTM in patients with mild Alzheimer’s Disease (AD).
“We are pleased to have completed enrollment in our Phase 2a study of Lomecel-BTM for Alzheimer’s Disease. We look forward to building on our Phase 1b study, which met its primary endpoint of safety and was published in a leading journal, Alzheimer’s and Dementia, the Journal of the Alzhiemer’s Association this year. We are excited to advance our program designed to assess the therapeutic potential of Lomecel-BTMin patients with AD,” said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer of Longeveron
The Phase 2a trial follows the previously announced positive results of Longeveron’s Phase 1b clinical trial of Lomecel-BTMfor Alzheimer’s Disease. In that trial, the primary endpoint of safety was met. That trial was a randomized, placebo-control design and measured endpoints in several domains, including measures of cognitive function and quality of life, brain volumetry using magnetic resonance imaging, and circulating biomarkers.
The Phase 2a trial, called the CLEAR MIND Trial, is a 48 patient, 4-arm, parallel design, randomized (1:1:1:1) Phase 2a clinical trial of Lomecel-BTM to evaluate the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild Alzheimer’s Disease (AD). The primary endpoint is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after administration of Lomecel-BTM. Secondary and exploratory endpoints include brain volumetry by magnetic resonance imaging (MRI), biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function.
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 a multi-modal mechanism of action that is 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 Frailty. Additional information about the Company is available at www.longeveron.com.
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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 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; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan and other jurisdictions; 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 the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditures 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, 2021, filed with the SEC on March 11, 2022, and the Company’s Quarterly Reports on Form 10-Q for the periods ended March 31, and June 30, 2022. 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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