Health
Biotech Sector Working Fast to Combat Alzheimer’s Disease Cases That are Set to Explode
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FN Media Group Presents USA News Group News Commentary
VANCOUVER, B.C., March 15, 2023 /PRNewswire/ — March 15, 2023 – USA News Group – According to a 2022 study of more than 6 million patients 65 and older, the risk factor for developing Alzheimer’s disease increases by 50-80% in older adults who caught COVID-19. With Statista stating nearly 11.5 million COVID-19 cases of people over 65 years old as of November 23, 2022, and the Alzheimer’s Association forecasting global dementia cases to triple by 2050, society is about to get hit with a tsunami of this devastating disease. Thankfully the biotech sector is working diligently to try and combat this coming onslaught of Alzheimer’s and dementia, through new diagnostic methods and treatments, including work from companies such as Marvel Biosciences Corp. (TSXV:MRVL), Biogen Inc. (NASDAQ:BIIB), Prothena Corporation plc (NASDAQ:PRTA), Intra-Cellular Therapies (NASDAQ:ITCI), and Roche Holding AG (OTC:RHHBY).
In the case of Marvel Biosciences Corp. (TSXV:MRVL), the biotech company is moving forward with its lead asset MB-204 in targeting Alzheimer’s and depression. MB-204 is a novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a receptor antagonist used for the treatment of Parkinson’s disease.
Both Istradefylline and MB-204 are highly active derivatives of caffeine, the most widely consumed psychoactive drug in the world. Caffeine consumption has been associated with a reduced risk for developing Parkinson’s disease, Alzheimer’s disease and improving mood and concentration.
Through Marvel Biotechnology, its wholly-owned subsidiary, Marvel BioSciences initiated its 7-day dose-ranging, toxicology study, using rats, for MB-204, marking a vital step in preparation to initiate FDA Phase I human clinical trials.
“We have significantly de-risked the development of our lead drug candidate MB-204 and have a strong understanding of its safety and risk profile, as we have redeveloped this candidate from an existing FDA-approved drug Istradefylline,” said Rod Matheson, CEO of Marvel Biosciences. “We are on time and on budget to enter FDA Phase I human trials by early 2023. MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer’s Disease and Depression. Our studies, as noted in previous press releases, have been extremely encouraging and we look forward to introducing a novel product that we have full commercial rights to for a very large and growing market that is in real need of a new and effective approach to treatment.”
After completing the maximum tolerated single dose studies, the FDA requires another short study before entering the industry standard Good Lab Practice toxicology studies. This type of study requires toxicology studies in two species, typically rats and dogs, to test the safety of new drugs before being able to run trials on humans.
“This is the final milestone experiment we need to execute in order to identify the optimal doses for our upcoming 4-week GLP rat study, which in combination with our dog studies, will allow us to start human clinical testing of MB-204,” said Dr. Mark Williams, Chief Science Officer of Marvel BioSciences. “We are commencing the dog dose ranging study shortly and will update the market on our progress shortly thereafter.”
Through partners Eisai Co., biotech company Biogen Inc. (NASDAQ:BIIB) recently announced the full results from a Phase 3 Confirmatory Clarity Ad Study of Lecanemab for the treatment of Early Alzheimer’s Disease.
Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
What the closely watched trial showed was a slowing of cognitive decline, however also may carry a risk of serious side effects for certain patients, including bleeding in the brain.
“All of these amyloid-lowering drugs carry a risk for increased brain hemorrhage,” said Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota. “I think the primary outcomes, the secondary outcomes, the amyloid-lowering is pretty impressive.”
Prothena Corporation plc (NASDAQ:PRTA) is currently testing an amyloid-targeting shot, which RBC Capital Markets analyst Brian Abrahams says “from a profile standpoint (Prothena’s drug) is significantly more potent.”
Prothena’s Alzheimer’s disease portfolio spans next generation antibody immunotherapy, small molecule and vaccine approaches, geared toward building upon first generation treatments to advance the treatment paradigm.
The company has initiated a Phase 1 study of PRX012, a potential best-in-class, next-generation anti-amyloid beta (Aβ) antibody under investigation for the treatment of Alzheimer’s disease. Back in April, PRX012 was granted Fast Track designation by the FDA.
“With its substantially higher binding strength that allows for simple subcutaneous administration, PRX012 is positioned to potentially lead a paradigm shift in Alzheimer’s treatment,” said Gene Kinney, CEO of Prothena.
Dealing with the behavioral disturbances associated with dementia and Alzheimer’s Disease is a goal for Intra-Cellular Therapies (NASDAQ:ITCI). One of the company’s ongoing programs is its ITI-1284-ODT-SL program, which is a deuterated form of lumateperone.
Intra-Cellular expects to commence clinical conduct in Phase 2 clinical trials in agitation in patients with probable Alzheimer’s disease, in dementia-related psychosis and certain depressive disorders in the elderly in 2023. However, ITI- 1284 is still an investigational agent and has not been approved for use for any indication.
A Phase 1 program found that ITI-1284 ODT-SL was rapidly absorbed into the systemic circulation, was metabolically stable, and resulted in high systemic exposure.
“We are excited about our late-stage lumateperone programs in depressive disorders and the advancement of a long-acting injectable formulation into clinical trials as well as further expanding our pipeline with ITI-1284,” said Sharon Mates, PhD, Chairman and CEO of Intra-Cellular Therapies.
Helping to diagnose Alzheimer’s disease more accurately and in a more timely fashion, Roche Holding AG (OTC:RHHBY) received FDA clearance for its Elecsys Alzeheimer’s disease (AD) CSF assays. Currently, the diagnosis of Alzheimer’s is a diagnosis of exclusion, largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan).
Clinical criteria are currently limited and lead to an accurate diagnosis in only 70-80% of cases, whereas the Elecsys AD CSF assays achieve 90% concordance with the Amyloid PET scan imaging, and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid in the brain.
“Globally, up to 75% of people living with Alzheimer’s disease have not been diagnosed, and those who have, often report a long and complicated process,” said Thomas Schinecker, CEO of Roche Diagnostics. “The Elecsys AD CSF assays have the potential to guide more people with suspected Alzheimer’s disease towards a diagnosis than ever before. As we are starting to see exciting results for new potential Alzheimer’s treatments, reliable tests that have been clinically validated will be critical in ensuring the right patients are identified and able to benefit from them.”
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Health
High-risk places affected by respiratory outbreaks | Local News | chroniclejournal.com – The Chronicle Journal
A respiratory virus outbreak has been declared at Southbridge Lakehead long-term care home.
The outbreak is facility-wide at the Vickers Street home. Restrictions are in place on admissions, transfers, discharges, social activities and visitation until further notice.
There are now four active respiratory outbreaks in high-risk settings in the Thunder Bay district, including at Hogarth Riverview Manor on the first floor and 2 North and on Plaza 1 at Pioneer Ridge.
A facility-wide COVID-19 outbreak is also ongoing at the Manitouwadge Hospital.
There are no active influenza outbreaks in the district.
The Thunder Bay District Health Unit reports that emergency department visits because of respiratory-related complaints have decreased and are at seasonal levels in its catchment area and the influenza A surge overall has subsided with the peak in cases and hospitalizations having taken place in November of 2022.
COVID-19 does continue to circulate with 104 new lab-confirmed cases in the last seven days.
Hospitalization numbers are stable with 23 people in the hospital with COVID in the district, including three in intensive care units.
The health unit continues to stress the importance of precautions like getting the annual flu vaccine and latest COVID booster as well as wearing a face mask, particularly indoors and crowded places. Also, stay home when sick.
Health
WHO advisers to consider whether obesity medication should be added to Essential Medicines List
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Advisers to the World Health Organization will consider next month whether to add liraglutide, the active ingredient in certain diabetes and obesity medications, to its list of essential medicines.
The list, which is updated every two years, includes medicines “that satisfy the priority health needs of the population,” WHO says. “They are intended to be available within the context of function health systems at all times, in adequate amounts in the appropriate dosage forms, of assured quality and at prices that individuals and the community can afford.”
Jeremy Mitchell and family
Courtesy Jeremy Mitchell
The list is “a guide for the development and updating of national and institutional essential medicine lists to support the procurement and supply of medicines in the public sector, medicines reimbursement schemes, medicine donations, and local medicine production.”
The WHO Expert Committee on the Selection and Use of Essential Medicines is scheduled to meet April 24-28 to discuss revisions and updates involving dozens of medications. The request to add GLP-1 receptor agonists such as liraglutide came from four researchers at US institutions including Yale University and Brigham and Women’s Hospital.
These drugs mimic the effects of an appetite-regulating hormone, GLP-1, and stimulate the release of insulin. This helps lower blood sugar and slows the passage of food through the gut. Liraglutide was developed to treat diabetes but approved in the US as a weight-loss treatment in 2014; its more potent cousin, semaglutide, has been approved for diabetes since 2017 and as an obesity treatment in 2021.
The latter use has become well-known thanks to promotions from celebrities and on social media. It’s sold under the name Ozempic for diabetes and Wegovy for weight loss. Studies suggest that semaglutide may help people lose an average of 10% to 15% of their starting weight – significantly more than with other medications. But because of this high demand, some versions of the medication have been in shortage in the US since the middle of last year.
The US patent on liraglutide is set to expire this year, and drugmaker Novo Nordisk says generic versions could be available in June 2024.
The company has not been involved in the application to WHO, it said in a statement, but “we welcome the WHO review and look forward to the readout and decision.”
“At present, there are no medications included in the [Essential Medicines List] that specifically target weight loss for the global burden of obesity,” the researchers wrote in their request to WHO. “At this time, the EML includes mineral supplements for nutritional deficiencies yet it is also described that most of the population live in ‘countries where overweight and obesity kills more people than underweight.’ “
WHO’s advisers will make recommendations on which drugs should be included in this year’s list, expected to come in September.
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“This particular drug has a certain history, but the use of it probably has not been long enough to be able to see it on the Essential Medicines List,” Dr. Francesco Blanca, WHO director for nutrition and food safety, said at a briefing Wednesday. “There’s also issues related to the cost of the treatment. At the same time, WHO is looking at the use of drugs to reduce weight excess in the context of a systematic review for guidelines for children and adolescents. So we believe that it is a work in progress, but we’ll see what the Essential Medicines List committee is going to conclude.”
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Re-emerging levels of respiratory illness have caused increased patient numbers at the HSC Children’s pediatric intensive care unit over the last week, and some non-urgent procedures may be postponed, Shared Health says.
On Thursday morning, there were 17 pediatric patients in the intensive care unit, and a considerable number of which were already experiencing health issues that were aggravated by respiratory illness. The unit’s normal baseline is nine, Shared Health said in a Thursday media release.
The release said patient volumes at the children’s emergency department are stable but more children with flu-like symptoms have been recorded coming in over the last two weeks, going from a low of 22 in mid-March to 47 on Wednesday.
A variety of respiratory illnesses are spreading through the community and have contributed to the increased level of patients in the pediatric intensive care unit, according to Shared Health.
Meanwhile, the number of patients in the neonatal intensive care unit was at 51 on Thursday morning, which is slightly above the unit’s normal baseline capacity of 50.
Ten staff are being temporarily reassigned to the pediatric intensive care unit to deal with the increased level of patients, the release said.
Some staff are being pulled from the pediatric surgical and recovery units, which means non-urgent procedures may be postponed due to the reassignments, Shared Health said.
Families of patients impacted by the postponements will be contacted, they said, and all urgent and life-threatening surgeries will go unhindered.
Families can protect their children from respiratory illnesses by limiting their contact with people exhibiting cold-like symptoms, washing their hands frequently and staying up to date on vaccinations, Shared Health said.
Patient volumes increased last month
While overall wait times at emergency and urgent care centres were stable in February, Shared Health said daily patient volumes in the province went up.
The daily average of patients seeking care was 750 last month, which is an increase from 730.4 in January, according to a separate Thursday news release.
The average length of stay for patients in emergency or urgent care units to be transferred to an inpatient unit went down to 21.77 hours last month, which is an improvement from 22.5 hours in January, the release said.
The overall number of people who left without being seen went down last month, from 13 per cent in January to 12.1 per cent in February, according to Shared Health. It also decreased at the HSC emergency department, from 25 per cent in January to 23.4 per cent last month.
Shared Health is reminding Manitobans to continue to call 911 in case of an emergency, and said the sickest and most injured patients will remain their priority.
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