This Phase 2a study is intended to build on encouraging preliminary Phase 1 data that were announced in 2021. Additionally, the Phase 2a trial is designed to measure brain anatomy using MRI, and include detailed assessments of the inflammatory and vascular systems thought to contribute to the worsening of AD. The study, which will be conducted at a minimum of 6 centers, is led by
“This is an important next step in the progress of our Alzheimer’s disease clinical program,” said
Dementia resulting from AD is associated with vascular function decline and involves a pro-inflammatory state. In Longeveron’s prior Phase 1 trial, Lomecel-B treatment met the primary safety endpoint, with no safety concerns – including no evidence of Alzheimer’s-related imaging abnormality, known as ARIA. In addition, the levels of certain pro-vascular and anti-inflammatory biomarkers increased in the Lomecel-B treated subjects compared to placebo.
The Phase 2a trial is a double-blind, randomized, placebo-controlled design investigating safety and tolerability, as well as secondary endpoints that include cognitive function and biomarkers, following single or multiple infusions of Lomecel-B compared to placebo, in individuals with mild AD. The study consists of 4 treatment arms of 12 patients each, for a total target enrollment of 48 patients.
About
Forward-Looking and Other Statements
Certain statements in this press release that are not historical facts are forward-looking statements that 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. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results, including achievement of primary endpoints; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. 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
Contact:
Stern Investor Relations
Tel: (212) 362-1200
Email: Brendan.payne@sternir.com
Source:
Source: LGVN
Source:
Source:
2022 GlobeNewswire, Inc., source