Palm Beach, FL – May 9, 2023 – FinancialNewsMedia.com News Commentary – Alzheimer’s disease (AD) is a progressive and neurodegenerative disorder that attacks the brain’s nerve cells or neurons, which results in loss of memory, thinking and language skills, and behavioral changes. There is a rapid growth in the number of people living with Alzheimer’s disease, and only around one in four people with the disease get diagnosed. A report from Mordor Intelligence projected that the Alzheimer’s disease diagnostics and therapeutics market is expected to be valued at USD 9,639.23 million 2027, registering a growth with CAGR of 5.51% over the forecast period. The report said: “The major factors driving the growth of the Alzheimer’s disease diagnostics and therapeutics market are the increasing use of biomarkers in Alzheimer’s diagnosis and drug development and the rising prevalence of Alzheimer’s worldwide. For instance, in September 2022, a report by the WHO stated that about 55 million people around the world are living with dementia, and nearly 10 million cases are reported annually. WHO also said that Alzheimer’s is the most common form of dementia and constitutes about 60-70% of the total cases of dementia.  Also, with the growing prevalence of Alzheimer’s around the world, government and non-government entities are investing heavily in developing diagnostics and therapeutics for the disease, which may augment the market’s growth.”  Active biotechs in the markets today include:   Silo Pharma, Inc. (NASDAQ: SILO), Eli Lilly and Company (NYSE: LLY), Acorda Therapeutics, Inc. (NASDAQ: ACOR), Trevena, Inc. (NASDAQ: TRVN), Immuron Limited (NASDAQ: IMRN).

Mordor Intelligence continued: “Additionally, with the advancement in diagnostic technologies and ongoing research activities in the area, the companies are enhancing their product offering and launching new products coupled with other business expansion initiatives like mergers and acquisitions, strategic collaboration, and new investments into other companies are also expected to complement the growth of the Alzheimer’s disease diagnostics and therapeutics market over the forecast period.  Therapeutics development leads to better drugs for Alzheimer’s treatments, thereby driving the growth of the studied market… Thus, due to the use of biomarkers, increasing research and development, and advanced diagnostic technologies, the studied market is expected to witness healthy growth over the forecast period.   With the increasing number of research studies related to the diagnosis and management of Alzheimer’s disease and high investment in the country over Alzheimer’s by the government and private entities, the market is expected to grow in the United States over the forecast period… Therefore, due to the high burden of Alzheimer’s disease and huge investment in research and development activities, coupled with the launch of new products, the Alzheimer’s disease diagnostics, and therapeutics market is expected to grow over the forecast period in the region.”

Silo Pharma, Inc. (NASDAQ: SILO) BREAKING NEWS:  Silo Pharma’s SPC-15 Awarded U.S. Patent to Protect Ongoing R&D of Therapeutic for Stress-Induced Affective Disorder and Alzheimer’s Disease — Silo Pharma, Inc. (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent 11,622,948 titled “Biomarkers for Efficacy of Prophylactic Treatments Against Stress-Induced Affective Disorders.” The new patent claims cover the use of biomarkers in determining the efficacy of the Company’s portfolio drug SPC-15, a targeted prophylactic treatment utilizing ketamine compositions, as a method of treatment for a stress-induced affective disorder or stress-induced psychopathology.

“This patent is an important addition to our intellectual property, further protecting the key technology behind SPC-15 in which metabolomic biomarkers predict the response to pharmacological treatments and measure efficacy,” said Eric Weisblum, Chief Executive Officer of Silo Pharma. “Based on our latest research with Columbia University on SPC-15, this IP expands the claims of the original patent.”

Silo Pharma owns an option to license certain assets currently undergoing studies at Columbia University for stress-induced affective disorders and Alzheimer’s disease.  CONTINUED…  Read this full release for Silo Pharma at:  https://www.financialnewsmedia.com/news-silo/

Other recent biotech developments in the markets include:

Eli Lilly and Company (NYSE: LLY) recently announced positive results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. Donanemab met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer’s Disease Rating Scale (iADRS). The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events. All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits with similar magnitude. Based on these results, Lilly will proceed with global regulatory submissions as quickly as possible and anticipates making a submission to the U.S. Food and Drug Administration (FDA) yet this quarter. Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals.

“Over the last 20 years, Lilly scientists have blazed new trails in the fight against Alzheimer’s disease by elucidating basic mechanisms of AD pathology and discovering imaging and blood biomarker tools to track the pathology,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. “We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial. This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”

Acorda Therapeutics, Inc. (NASDAQ: ACOR) and Hangzhou Chance Pharmaceuticals Co. Ltd. recently announced that they have entered into distribution and supply agreements to provide INBRIJA^® in China. INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.

Under the terms of the agreements, Acorda will receive an up-front payment of $2.5 million, a near term milestone payment of up to $6 million, $3 million upon regulatory approval, up to $132.5 million in sales milestones, and a fixed fee for each carton of INBRIJA supplied to Chance. By 2030, it is estimated that China will have approximately 5 million people with Parkinson’s disease due to its aging population¹. Chance plans to seek regulatory authorization as quickly as possible.

Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, recently announced that its partner in China, Jiangsu Nhwa, received formal approval from the National Medical Products Administration for OLINVYK. It has been approved for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

“We are very pleased to see our partners, Jiangsu Nhwa, achieve this important milestone which will allow Chinese patients to benefit from OLINVYK,” said Carrie Bourdow, President and CEO of Trevena. “We have worked closely with our partners during their submission process, and look to our continued collaboration as they move forward with launch and full commercialization of OLINVYK in China.”

Immuron Limited (NASDAQ: IMRN) recently announced that the US Naval Medical Research Center (NMRC) has received approval from the US Food and Drug Administration (FDA) to proceed with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli(ETEC) developed in collaboration with Immuron. The FDA has removed a clinical hold on the Investigational New Drug (IND) application allowing the NMRC to proceed with its plans to evaluate the efficacy of the hyperimmune product to prevent infectious diarrhoea caused by Campylobacter and ETEC which is now active.

The safety and protective efficacy of the product will be tested utilising two controlled human infection-model clinical trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against ETEC infections, and the second trial focusing on moderate to severe campylobacteriosis. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the randomized, placebo-controlled trials and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. jejunicontrolled human infection models

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