READ THE FULL LGVN RESEARCH REPORT
- Longeveron (NASDAQ:LGVN) announced the publication of results from the Phase I trial of the company's signature treatment, Lomecel-B, on patients with Alzheimer's disease.
- The publication verified what we previously had reported in our research report—that Lomecel-B was well tolerated by patients and appeared to show the potential to slow cognitive decline (details below).
- We remain excited about the prospects for Lomecel-B and Longeveron and look forward to the results of various Phase 2 tests that are ongoing—detailed below.
- The Phase I Alzheimer's test was double-blinded, randomized and placebo-controlled and conducted on 33 patients.
- In addition to the results shown below, the publication revealed that the Quality of Life in Alzheimer's Disease, which is used to assess patients' well-being, showed a significantly better score in the Lomecel-B group versus the placebo group after six months.
- MRI's taken of the patients' brains showed an increase in the left hippocampus volume three months after a high-dose Lomecel-B infusion versus the placebo. The hippocampus is the region of the brain critical to memory formation.
One of the most feared aspects of aging among many is the prospect of not being able to recognize those who have been known for years nor remember crucial and beloved memories of a life lived—in short—the prospect of being diagnosed with Alzheimer's Disease. We don't need to go into too many details of the dreaded disease as most are all too familiar with it, but it is the most common cause of dementia, accounting for between 60-80% of cases and afflicting as many as 5.8 million Americans according to the CDC—projected to grow to 14 million by 2060. There is no cure and currently, according to the Alzheimer's Association, there is only one treatment—aducanumab (brand name Aduhelm produced by Biogen and Neurimmune)—which removed amyloid, one of the hallmarks of Alzheimer's Disease.
According to the CDC, Alzheimer's Disease is the 6th leading cause of death among US adults and the 5th leading cause for adults aged 65 or older. And the costs to society are almost immeasurable in certain terms but in monetary terms, a paper by Winston Wong, who is a Scholar in Resident at the UCLA Kaiser Permanente Center for Health Equity, estimated the cost is 2020 at $305 billion, and estimated by the CDC to growth to more than $500 billion by 2040.
It is these tragic facts that Longeveron is attempting to mitigate with Lomecel-B. The company is testing Lomecel-B as a treatment for Alzheimer's based on the hypothesis that multiple possible mechanisms of action (MOAs) can simultaneously address multiple features of Alzheimer's. Preclinical studies show that MSCs (Medicinal Signaling Cells) can potentially reduce Alzheimer's-associated brain inflammation, improve the function of blood vessels in the brain, and reduce brain damage due to Alzheimer's Disease progression and promote regenerative responses.
Longeveron has completed the Phase I safety study of subjects with mild Alzheimer's disease and based on the success is now enrolling subjects for the Phase 2a clinical trial, which is designed to evaluate the safety of single and multiple administrations of two different doses of Lomecel-B. The Phase I trial was supported by a Part the Cloud grant from the Alzheimer's Association, which could result in payments from the company to the Association should a therapy reach commercialization status. Based on the preliminary results—seen below in the form of measuring memory with a Mini Mental State Exam (MMSE)—Longeveron is hopeful Lomecel-B may prove to be a disease-modifying therapy for Alzheimer's Disease. Longeveron published the results from the Phase I trial in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, confirming the positive results.
Given the positive trial results to this point, but also recognizing the challenges that remain, we believe LGVN continues to be a good investment opportunity for investors who are willing to ride some inevitable volatility and have a relatively high risk tolerance.
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