Palm Beach, FL – April 13, 2022 – FinancialNewsMedia.com News Commentary – Dementia is the loss of cognitive functioning, thinking, remembering, reasoning, and behavioral abilities to such an extent that it interferes with a person’s daily life and activities. These functions include memory, language skills, visual perception, problem-solving, self-management, and the ability to focus and pay attention. Alzheimer’s is the most common cause of dementia. The outbreak of the COVID-19 pandemic is expected to have a considerable impact on the dementia drugs market. According to a study titled, “The effects of the COVID-19 pandemic on people with dementia”, published in the National Library of Medicine, in January 2021, the population with dementia is at high risk of contracting COVID-19 infection as the cognitive symptoms cause difficulty to abide by the safety guidelines that were proposed to contain the viral spread. The study also stated that research from 2020 showed that these people have a relatively high risk of contracting severe COVID-19 and are also at risk of neuropsychiatric disturbances as a result of lockdown measures and social isolation. A report from Mordor Intelligence projected that the dementia drugs market was valued at approximately USD $13,459.39 million in 2021, and it is expected to witness a revenue of USD $21,332.59 million in 2027, with a CAGR of 8.28% over the forecast period. It said: “Further, the major factors fueling the market growth are the increasing prevalence of target diseases, the introduction of new and innovative technologies and drugs, and increased government funding and awareness programs for dementia.” Active Companies in the markets today include Longeveron Inc. (NASDAQ: LGVN), Sanofi (NASDAQ: SNY), Bristol Myers Squibb (NYSE: BMY), Takeda (NYSE:TAK), Johnson & Johnson (NYSE: JNJ).
Mordor Intelligence continued: “The increased government funding and awareness programs are the major factors driving the market growth. For instance, as per a February 2022 update, a new initiative by McGill University’s Dementia Education Program is among the 15 projects that will receive funding from the Public Health Agency of Canada to raise awareness of dementia and promote dementia-inclusive communities. Additionally, in October 2021, the Government of Kerala, India, launched the Dementia-Friendly District program, ‘Udbodh’. This initiative has been taken with a collaboration between Cochin University of Science and Technology’s NeuroScience department, the Ernakulam district administration as well as Kochi Municipal Corporation. Moreover, in January 2021, LSP, the leading European life sciences investor, launched the LSP Dementia Fund, a fund dedicated to combating neurodegenerative diseases. Such initiatives will boost the awareness of dementia drugs, thereby contributing to market growth.”
Longeveron Inc. (NASDAQ: LGVN) BREAKING NEWS: Longeveron Enters into Cooperative Research and Development Agreement with the US Department of Veterans Affairs for its Phase 2 Alzheimer’s Trial – Longeveron Inc. (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic, aging-related and life-threatening conditions, announced today a Cooperative Research and Development Agreement (CRADA) with the United States Department of Veterans Affairs (VA) for the addition of a Miami VA clinical site to its ongoing Phase 2 Alzheimer’s Disease (AD) trial.
As recently reported in a peer reviewed article in Alzheimer’s & Dementia,® The Journal of the Alzheimer’s Association, Longeveron’s Phase 1 trial met its primary endpoint, demonstrating that its drug Lomecel-B was well tolerated in Alzheimer’s patient. In addition, the data provided indications supporting further exploration of Lomecel-B, particularly the therapeutic potential to slow cognitive decline and improve quality of life in patients with AD.
“After meeting the rigorous requirements of the VA, we are pleased to announce the addition of this particular Miami VA site to our ongoing trial,” said Geoff Green, Chief Executive Officer at Longeveron. “This continued collaboration between Longeveron and the Miami VA reflects our ongoing dedication to finding a cure for this severe disease in the vital setting of the VA health system.”
This marks the third separate CRADA agreement between the VA and Longeveron, including an Aging Frailty study and an ongoing study on Covid-19, further cementing the strong partnership and focus on the Veteran population. The VA Miami Healthcare System provides primary and specialty health care services to approximately 63,000 Veterans in three south Florida counties – Miami-Dade, Broward and Monroe. The lead trial investigator at the Miami VA is Dr. Jorge G. Ruiz, the Associate Director of the VA’s Department of Geriatric Research Education and Clinical Center (GRECC).
“The Miami VA Healthcare System GRECC is, once again, pleased to be partnering with Longeveron on another important study,” Dr. Ruiz stated. “We share the goal of caring for our Veteran’s with Alzheimer’s disease, which is affecting many older Veterans and the overall older population,” he added.
The CLEAR MIND Trial, a Phase 2a study, 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 four treatment arms of 12 patients each, for a total target enrollment of 48 patients. CONTINUED… For more information about Longeveron, please visit https://investors.longeveron.com/news/default.aspx
Other recent developments in the biotech industry include:
Sanofi (NASDAQ: SNY) released new preclinical data demonstrated that tolebrutinib, Sanofi’s investigational oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of multiple sclerosis (MS), was the only BTK inhibitor with sufficient central nervous system (CNS) exposure and potency to modulate BTK signaling pathways within the CNS, as compared with evobrutinib and fenebrutinib. These results are being presented in a live poster presentation at the 7th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum.
Disability accumulation, or worsening of neurologic function, remains a reality for many people living with MS. Inhibition of BTK, an important intracellular signaling pathway within the CNS, is being investigated as an MS treatment strategy. However, to effectively inhibit BTK within the CNS, investigational therapies must cross the blood-brain barrier with sufficient exposure to engage targets and modulate signaling.
Bristol Myers Squibb (NYSE: BMY) recently announced results from the Phase 3 CheckMate -816 trial, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) in combination with chemotherapy significantly improved event-free survival (EFS), a primary endpoint, compared to chemotherapy alone in patients with resectable non-small cell lung cancer (NSCLC). With a minimum follow-up of 21.0 months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 37% (Hazard Ratio [HR] 0.63; 97.38% Confidence Interval [CI]: 0.43 to 0.91; p=0.0052) across randomized patients when administered before surgery. In patients receiving the combination, median EFS was 31.6 months, compared to 20.8 months for patients treated with chemotherapy alone.
Additionally, while the data are still immature and the analysis did not reach statistical significance, favorable early overall survival (OS) results were observed with Opdivo in combination with chemotherapy (HR 0.57; 99.67% CI: 0.30 to 1.07). At two years, 83% of patients treated with neoadjuvant Opdivo and chemotherapy were alive, compared to 71% with chemotherapy alone. OS will continue to be followed for upcoming analyses.
Takeda (NYSE:TAK) recently announced that the Phase 3 SHP643-301 study (NCT04070326) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events and no dropouts due to adverse events.
The study also successfully reached the secondary objective evaluating the clinical activity/outcome of TAKHZYRO in preventing hereditary angioedema (HAE) attacks as well as characterizing the pharmacodynamics of TAKHZYRO in pediatric subjects 2 to <12 years of age.
Johnson & Johnson (NYSE: JNJ) recently announced results for fourth-quarter and full year 2021. “Our 2021 performance reflects continued strength across all segments of our business. Guided by Our Credo, I am honored to assume the role of CEO, leading our global teams in continuing our work to deliver life-changing solutions to consumers, patients, and health care providers” said Joaquin Duato, Chief Executive Officer. “Given our strong results, financial profile, and innovative pipeline we are well positioned for success in 2022 and beyond.” Read the full announcement at https://finance.yahoo.com/news/johnson-johnson-reports-q4-full-112500666.html
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