Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Study Data at Alzheimer's Association International Conference
VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' or the 'Company'), a commercial-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced it will present new clinical data on ZUNVEYL at the Alzheimer's Association International Conference (AAIC), taking place July 27–31, 2025, in Toronto, Canada. The Company will share the following poster presentations:
Article content
Bioequivalence of ZUNVEYL
Article content
Article content
, a Galantamine Prodrug to Galantamine Hydrobromide Extended-Release Demonstrated Under
Article content
Steady State
Article content
Conditions (Poster #107147) – July 27
Article content
Bioequivalence of ZUNVEYL
Article content
, a Galantamine Prodrug to Galantamine Hydrobromide Immediate-Release Demonstrated Under
Article content
Fed and Fasting Conditions
Article content
(Poster#107030) – July 28
Article content
, a Galantamine Prodrug, Over a Dosage Range of Five to Fifteen Milligrams Demonstrated Under Fasting Conditions (Poster #107255) -July 30
Article content
'We are excited to present data demonstrating ZUNVEYL's bioequivalence and dose proportionality,' said Dr. Denis Kay, Chief Scientific Officer of Alpha Cognition. 'Given the high unmet need and challenges with current treatments, ZUNVEYL has the potential to offer physicians a well-tolerated therapy with compelling clinical benefits.'
Article content
AAIC is the world's largest forum for dementia research, convening global leaders in basic and clinical science to advance prevention, diagnosis, and treatment of Alzheimer's disease.
Article content
About Alpha Cognition Inc.
Article content
Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options.
Article content
ALPHA-1062 formulated as a delayed release oral tablet (ZUNVEYL), is an FDA approved new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI.
Article content
ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults.
Article content
IMPORTANT SAFETY INFORMATION
Article content
CONTRAINDICATIONS
Article content
ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred.
Article content
WARNINGS AND PRECAUTIONS
Article content
Serious Skin Reactions
Article content
: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered.
Article content
Anesthesia
Article content
Cardiovascular Conditions:
Article content
Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.
Article content
Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope.
Article content
Gastrointestinal Conditions
Article content
: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
Article content
Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL.
Article content
Genitourinary Conditions:
Article content
Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction.
Article content
Neurological Conditions:
Article content
Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL.
Article content
Pulmonary Conditions:
Article content
Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions.
Article content
ADVERSE REACTIONS
Article content
The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
Article content
DRUG INTERACTIONS
Article content
Use with Anticholinergics:
Article content
Galantamine has the potential to interfere with the activity of anticholinergic medications.
Article content
Use with Cholinomimetics and Other Cholinesterase Inhibitors:
Article content
A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.
Article content
USE IN SPECIFIC POPULATIONS
Article content
Pregnancy:
Article content
Based on animal data may cause fetal harm.
Article content
Hepatic Impairment:
Article content
In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended.
Article content
Renal Impairment:
Article content
In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended.
Article content
These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information.
Article content
Forward-looking Statements
Article content
This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the, the long-term benefits of ZUNVEYL, the Company's timing and planned activities and business strategy to launch ZUNVEYL, the potential timing for the availability of ZUNVEYL, the potential future developments of ZUNVEYL, the market size and demand for ZUNVEYL and the Company's potential growth opportunities, capital requirements. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks related to our focus on the long-term care market, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on January 10, 2025 and available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.
Article content
Article content
Article content
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CBC
42 minutes ago
- CBC
This cancer survivor celebrated her birthday by paying strangers' hospital parking fees
Krystyna Locke decided to celebrate her 63rd birthday in a very familiar place — the cancer clinic at her local hospital. The London, Ont., lymphoma survivor spent the last year fundraising to cover cancer patients' parking fees, one of the many out-of-pocket costs related to health care that can add up over time and become a burden. On Tuesday, she set up near an entrance at the London Health Sciences Centre with a stack of parking vouchers and a banner that reads: "Happy birthday to me. Your parking is free." "Today, I received hugs. I received kisses on the cheek. I shared tears with people. I shared laughter. There was joking. It just completely lightens the mood," Locke told As It Happens guest host Aarti Pole. "They're walking very heavy because they're carrying a burden, right? And when they saw my sign, they would walk up to me and, right away, a big smile on their face and they were so thankful." Locke's long cancer journey Locke can recognize that heaviness in strangers because she's experienced it herself. In 2004, she was diagnosed with non-Hodgkin lymphoma. "Walking into the cancer clinic, especially for the first time, you're terrified, you are anxious, it's unknown, and the carpet's been ripped out from under your feet," she said. "You have no idea if you're going to even survive the next year." Soon after her initial diagnosis, she says, doctors removed 26 lymph nodes from one side of her neck. But that was only the beginning of her cancer journey. Over the next two decades, she would return to the cancer clinic for regular checkups so doctors could monitor her health, until 2023, when a much more aggressive form of lymphoma developed on the other side of her neck. After that, she says, she had to undergo chemotherapy, and make more frequent visits to the London hospital's Verspeeten Family Cancer Centre. But, today, she is cancer-free. "When I was done my treatments, I just felt like I needed to do something more," she said. "I wanted to do something that would directly go to the patient. And what better way than covering their parking for the day?" Cancer's hidden costs Parking fees have long put a financial strain on patients in Canada, where health-care is free, but the associated non-medical costs are not. A Canadian Cancer Society report in December estimated cancer patients face on average almost $33,000 in out-of-pocket cancer-related costs in their lifetime, a number that's expected to rise with the cost of living. These costs, the report notes, include things like medication, lost wages, travel, caregiving, lodgings, food, and, yes, parking fees. "I've been going to the cancer clinic for over two decades, and when you're there … you do strike up conversations with other patients," Locke said. "The common theme was how long we're waiting [and] we know that that means our parking is going to cost more." At the London Health Sciences Centre, the maximum daily parking fee is $12. But at hospitals in downtown Toronto, those daily rates can be more than twice as much. A London Health Sciences Centre spokesperson acknowledged the financial burden that comes with parking fees, especially for long-term patients, but said the revenue collected goes towards the hospital's operational costs. In fact, hospitals in Ontario have to re-invest their parking fees under provincial regulations, put in place in 2016. Those rules also require institutions that charge more than $10 a day to offer patients, their family members and visitors five-day, 10-day and 30-day passes at a 50 per cent discount off the daily maximum rate. But when hospitals don't own parking lots, nearby private parking isn't subject to the rules. WATCH | The out-of-pocket costs of cancer care: Cancer costs Canadian patients $33K on average 8 months ago An NDP motion to eliminate hospital parking fees for patients, families, and health-care workers in Ontario — and cover revenue shortfalls for hospitals — was voted down in June. Nova Scotia started covering the cost of hospital parking in May for patients, health-care workers and visitors. Quebec, since 2020, has offered free parking for the first two hours at public health institutions for patients and visitors, and capped hospital parking fees at $10 a day. British Columbia ended its two-year free hospital parking in 2022, saying that too many drivers abused the system for non-health-care-related reasons. The province still covers the cost for patients receiving dialysis or cancer treatment in acute-care programs, and for parents or caregivers of children staying in the hospital overnight. While Locke says free hospital parking would be the ideal scenario, she says people who want to help ease patients' burden can do so right now by following her lead. She raised $3,700 throughout the year, first by collecting empty beer and liquor bottles from friends and family, and later by teaming up with the hospital to create a fundraising page. On Tuesday, she was able to cover parking for roughly 300 patients. "A lovely surprise," said Trish Eagleson, one of the people who received a free parking pass from Locke. "It's a wonderful initiative." While she's giving back to others, Locke says it's also a birthday gift for herself. "They brought me as much joy as I was bringing to them, because I know how they're feeling at that moment when they're walking into the clinic," she said. "It's just a wonderful feeling knowing that I was making someone happy." Locke, whose actual birthday is in July, plans to return next summer to celebrate her 64th.
CTV News
an hour ago
- CTV News
Mysterious object seen above southern Ontario puzzles stargazers
Professor Jesse Rogerson says the strange bowtie-shaped light which captured the attention of stargazers was the spent stage of a rocket which launched in Fla.
Globe and Mail
an hour ago
- Globe and Mail
When 90% Isn't an A+: Elevance's Cost Crunch and Carelon's Cushion
Elevance Health, Inc. ELV, like most peers in the health benefits space, is contending with pressure from rising medical cost trends in ACA plans, slower Medicaid rate recovery, and higher utilization, prompting a reduction in its 2025 outlook. In the first half of the year, benefits expense surged nearly 18% to more than $72 billion, while cost of products sold climbed almost 19% to $10.3 billion. The second-quarter benefit expense ratio reached 88.9%, up 260 basis points year over year. Elevance now projects a full-year ratio of about 90%, versus 88.5% in 2024. This leaves a smaller share of premiums after paying claims, compressing margins. However, growth in the commercial segment and Carelon operations should offer support. Commercial individual memberships rose 9.7% in the first half of 2025, following a 25.6% increase in 2024. The broader commercial business, typically enjoying higher margins, is expected to sustain its expansion. Carelon's expanding value-based care model and pharmacy services will also provide a stabilizing influence. In the CarelonRx unit, growing adjusted scripts and acquisitions should drive performance, while operational gains in Carelon Health will aid the Carelon Services arm. Diversification efforts have boosted Carelon's overall revenue contribution, with segment growth of 12.4% in 2024 and a 36.8% jump in the first half of 2025. For full-year 2025, we expect it to advance nearly 30%, fueled by about 60% growth in Carelon Services alone. Together, Elevance's commercial strength and Carelon's diversified growth could help counterbalance margin pressures from elevated medical costs and funding challenges in government programs. How ELV's Peers Are Suffering? Companies like UnitedHealth Group Incorporated UNH and Centene Corporation CNC are also facing the brunt of rising medical costs. UNH's medical care ratio was 89.4% in the second quarter, which deteriorated 430 bps from the year-ago period. UnitedHealth reported Q2 adjusted EPS of $4.08, which missed the Zacks Consensus Estimate of $4.84. Meanwhile, Centene's health benefits ratio of 93% deteriorated 540 basis points year over year in the second quarter and came above the consensus mark of 90.82%. Centene reported adjusted loss per share of 16 cents in the second quarter, which missed the Zacks Consensus Estimate of earnings of 68 cents. Elevance's Price Performance, Valuation and Estimates Shares of ELV have lost 20.7% in the year-to-date period compared with the industry 's decline of 3.9%. From a valuation standpoint, Elevance trades at a forward price-to-earnings ratio of 9.19, down from the industry average of 14.57. ELV has a Value Score of A at present. The Zacks Consensus Estimate for Elevance's 2025 earnings is pegged at $30.59 per share, implying a 7.4% decline from the year-ago period. Image Source: Zacks Investment Research The stock currently carries a Zacks Rank #5 (Strong Sell). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. See our %%CTA_TEXT%% report – free today! 7 Best Stocks for the Next 30 Days Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report UnitedHealth Group Incorporated (UNH): Free Stock Analysis Report Centene Corporation (CNC): Free Stock Analysis Report Elevance Health, Inc. (ELV): Free Stock Analysis Report This article originally published on Zacks Investment Research (
