- Longeveron recently released topline results from its Phase 2a trial evaluating Lomecel-B(TM) as a potential treatment for mild AD
- The study met its primary safety endpoint across all four study groups and showed positive and statistically significant results in secondary endpoint involving the Composite Alzheimer’s Disease Score (“CADS”) for Lomecel-B(TM) and components of the CADS
- The positive results are expected to form the basis for further development of Lomecel-B(TM) as a potential treatment for mild AD
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions for which there is an unmet medical need, announced on October 5 its topline results from its Phase 2a trial, called the CLEAR MIND trial, investigating Lomecel-B(TM) for the treatment of mild Alzheimer’s disease (“AD”) (https://nnw.fm/nD0Yk). The announcement was featured in a recent NetworkNewsAudio (“NNA”) broadcast, which is part of an overall goal to deliver additional visibility, recognition, and brand awareness in the investment community (https://nnw.fm/UGTYL).
Lomecel-B(TM) is an allogeneic medicinal signaling cell (“MSC”). MSCs appear to possess anti-inflammatory, pro-vascular, and pro-regenerative properties.
The study met its primary safety endpoint across all study groups based on statistical and medical assessments, with the safety data consistent with an established safety profile with no incidence of hypersensitivity, no cases of Alzheimer Related Imagine Abnormalities (“ARIA”), no clinically asymptomatic microhemorrhages, and no notable changes in laboratory evaluations and electrocardiogram (“ECG”) reported. Moreover, the study revealed statistically significant improvements in the secondary endpoint Composite Alzheimer’s Disease Score (“CADS”) for Lomecel-B(TM) and specific components of the CADS.
“These study results with Lomecel-B(TM) are encouraging,” commented Dr. Jeffrey Cummings, MD, Vice Chair of Research at UNLV’s Department of Brain Health. “The study met its primary safety endpoint and is supported by lack of deterioration in cognitive or atrophy signals. The efficacy observations are encouraging, and these results should be used as a foundation for further studies.”
We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B(TM) in the treatment of Alzheimer’s Disease, and provide a solid foundation for additional clinical trials in this and other indications,” said Wa’el Hashad, CEO of Longeveron.
Longeveron initiated the CLEAR MIND trial in January 2021 with the aim of obtaining safety and efficacy data following single and multiple infusions of two different dose levels of Lomecel-B(TM) compared to placebo. The study employed a double-blind, 4-arm, parallel design in which 48 patients with mild AD were randomized into the four arms at an allocation ratio of 1:1:1:1, meaning each treatment arm had 12 patients (https://nnw.fm/Iua5H).
In an October 5 webcast during which the company discussed the topline results, Dr. Nataliya Agafonova, Chief Medical Officer of Longeveron, clarified that a total of 49 patients had been treated in the study, 22 being male, with the rest female (https://nnw.fm/aO5y9). The study was conducted over 45 weeks, which included a 6-week screening period, 12-week treatment period, and 27-week follow-up period.
The study built on positive Phase 1 data reported in 2021 following the completion of the Phase 1 study, which met its primary safety endpoint. Positive secondary efficacy assessments supported the potential therapeutic benefit of Lomecel-B(TM), according to an April 2021 news release (https://nnw.fm/bZM5V). Lomecel-B(TM) resulted in a slower decline in cognitive function in patients who received low dose Lomecel-B(TM) compared with placebo. Moreover, quality of life metrics appeared to improve with Longeveron’s Lomecel-B(TM) investigational product as compared to placebo. These results were published in a leading journal, Alzheimer’s and Dementia, the Journal of the Alzheimer’s Association, last year (https://nnw.fm/4L175).
Looking ahead, Longeveron plans to announce additional exploratory and biomarker data from the Phase 2a trial which may provide additional insights of the clinical effects of Lomecel-B(TM) in the study population, according to Mr. Hashad.
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 https://nnw.fm/LGVN
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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