作者: Atta, Aref ; Bajwa, Hammad ; Alrandi, Muneera ; Shaghouli, Amna ; El Baba, Sarah ; Nassar, Ayham ; Dhanwal, Dinesh ; Jabbar, Abdul ; Hatahet, Mohamed ; Alsaeed, Abdulghani ; Khudadah, Khaled ; Jallo, Mahir ; Aldossari, Khaled ; Bashier, Alaaeldin ; Ngome, Mary ; Nader, Rita ; Haroon, Abuljaboor ; Aly, Hazem ; Al Jammah, Anwar ; Mahmood, Dhafir ; Ajaz, Yasmeen ; Al Quraini, Hussain ; Zied, Nedal Abu ; AlKadhim, Ibrahim ; Hassanein, Mohamed ; Nafach, Jalal ; Steitieh, Habib ; Cinar, Tarhan ; Khader, Said ; Alawadi, Fatheya ; Muzaffar, Talal ; Bajawi, Dalila ; Rashid, Fauzia

INTRODUCTION:

Oral semaglutide, a glucagon-like peptide 1 receptor agonist, requires administration on an empty stomach with up to 120 mL of water, followed by no intake of food, beverages, or other oral medications for at least 30 min to ensure optimal absorption. These instructions can be challenging to adhere to during Ramadan when patients fast for extended periods. The O-SEMA-FAST study assessed the impact of fasting on adherence to oral semaglutide dosing instructions and its subsequent effects on glycaemic control and body weight.

METHODS:

O-SEMA-FAST was a non-interventional, prospective study conducted in 2023 in people with type 2 diabetes mellitus (T2DM) who fasted during Ramadan and were on oral semaglutide treatment in the United Arab Emirates, Saudi Arabia, and Kuwait. Patients were followed for 20 weeks. Glycated haemoglobin (HbA1c) and body weight were measured at baseline and at the end of the study (EOS); changes were analysed by mixed models for repeated measures.

RESULTS:

Among the 257 patients included in the final analysis, there was a significant reduction in HbA1c (- 0.2%-points, p = 0.01) and a notable decrease in body weight (- 2.6 kg, p < 0.0001) from baseline to EOS. Of the 215 patients who recorded administration details in their diaries, 68.4% (n = 147) adhered to dosing instructions for ≥ 80% of diary days. Baseline mean HbA1c was 6.7% in adherent patients and 7.0% in non-adherent patients. At EOS, the change in HbA1c was - 0.3%-points (95% confidence interval, CI - 0.4, - 0.2; p < 0.0001) for adherent patients and - 0.1%-points (95% CI - 0.4, 0.1; p = 0.3) for non-adherent patients. The change in body weight was - 3.2 kg (95% CI - 4.0, - 2.4; p < 0.0001) for adherent patients and - 1.6 kg (95% CI - 2.5, - 0.8; p = 0.0001) for non-adherent patients. An increase in self-reported hypoglycaemic events (HEs) was observed, but no severe events were reported. Gastrointestinal disorders were the most common adverse effects. Among patients with available data on self-reported HEs (n = 216), 67 (31.0%) experienced HEs. The mean age, HbA1c levels and T2DM duration of patients with vs without HEs were 51.0 vs 53.3 years, 6.99 vs 6.66% and 9.2 vs 7.9 years. A greater proportion of patients experiencing HEs were treated with oral antidiabetic drugs like biguanides (90.6% vs 86.7%), sodium glucose cotransporter 2 inhibitors (85.9% vs 80.7%), sulfonylureas (32.8% vs 25.9%) and dipeptidyl peptidase 4 inhibitors (20.3% vs 11.1%).

CONCLUSION:

The O-SEMA-FAST study demonstrated that most participants adhered to oral semaglutide instructions and experienced significant reductions in HbA1c and body weight. Overall, baseline characteristics were similar regardless of HEs; however, patients reporting HEs were younger, had higher HbA1c levels, longer T2DM duration and were under polypharmacy. Oral semaglutide is a suitable choice for individuals who fast during Ramadan, effectively controlling glycaemic levels and managing body weight while maintaining a favourable safety profile.

TRIAL REGISTRATION:

NCT05716724.

2025-04-01·Journal of Physiotherapy

Critically appraised paper: Once-weekly semaglutide in people with obesity and knee osteoarthritis [commentary]

Article

作者: Adie, Sam

2025-03-01·DIABETES OBESITY & METABOLISM

An exploratory analysis of glucagon‐like peptide‐1 (GLP‐1) agonists and biosimilars: A literature review

Review

作者: Razick, Adam ; How‐Volkman, Christiane ; Akhtar, Muzammil ; Truong, Alina ; Frezza, Eldo ; Razick, Daniel ; Nadora, Denise ; Wen, Jimmy ; Karabala, Muhammad ; Bernstein, Ethan

Abstract:

Glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) are at the forefront of treating the global health crisis of diabetes mellitus (DM) and obesity. However, the demand for GLP‐1 RAs has far outstripped its supply and comes with a high monthly cost. Thus, the development of GLP‐1 RA biosimilars can potentially address these barriers by providing greater access to medications that provide clinical outcomes similar to those of the reference products. A narrative review was conducted to examine the current and future developments for GLP‐1 RA biosimilars. Liraglutide and semaglutide are the predominant GLP‐1 RAs being investigated for the development of biosimilars. Preliminary liraglutide biosimilar comparisons to reference liraglutide have demonstrated similar clinical efficacy and safety profiles. Semaglutide and beinaglutide biosimilars are currently under investigation as well. With the growing popularity of GLP‐1 RAs, accessibility and affordability remain a challenge as monthly costs without insurance for liraglutide, semaglutide and tirzepatide are $1418, $892, and $974 respectively. This trend negatively impacts patients with obesity and DM as well as patients who can utilize it for off‐label indications for conditions that benefit from weight loss such as obstructive sleep apnoea and non‐alcoholic fatty liver disease. A substantial number of pharmaceutical and healthcare companies worldwide are conducting clinical trials on their GLP‐1 RA biosimilars. Preliminary results from liraglutide biosimilars are promising, and several semaglutide biosimilars are currently being investigated. Future research should focus on conducting comparative head‐to‐head trials to determine the clinical outcomes between biosimilars and reference products.

项与 Semaglutide(Vivani Medical) 相关的新闻（医药）

2025-06-11

·GlobeNewswire-Health Care

Vivani Medical Appoints Anthony Baldor as Chief Financial Officer

ALAMEDA, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, today announced the appointment of Anthony Baldor as Chief Financial Officer. Baldor succeeds Brigid A. Makes, who has decided to retire from Vivani to focus on her board appointments and personal projects after a distinguished career and significant contributions to the Company. Baldor brings more than 20 years of financial management experience in the biotechnology sector, with a proven record in fundraising, business development and corporate strategy. Prior to joining Vivani, Baldor was Chief Financial Officer at Diakonos Oncology Corp., where he led the company’s Series Seed and Series A financings, and Vice President of Corporate Strategy & Development at 4D Molecular Therapeutics, Inc., where he played a pivotal role in the company’s Series C financing, initial public offering and various key partnership activities. His experience also includes positions at Jefferies Group LLC, BioInnovation Capital, LLC, RMI Partners, and Cequent Pharmaceuticals, Inc. Baldor holds both an M.B.A. and a Master of Data Science from the University of California, Berkeley, and a B.A. from Vassar College. “Anthony’s deep expertise in financial strategy will be instrumental as Vivani advances its pipeline and scales its operations,” said Vivani Chief Executive Officer Adam Mendelsohn, PhD. “We are excited to welcome him to the leadership team at this pivotal time for the Company.” Dr. Mendelsohn continued: “On behalf of the Board and the entire Vivani team, I thank Brigid for her outstanding leadership and dedication. Her expertise and vision have been invaluable to our growth and success. This includes helping guide our company through a transformative period, including the successful completion of the merger of Nano Precision Medical and Second Sight Medical Products, and the advancement of our clinical and commercial strategy.” Makes will continue to serve in an advisory capacity during the transition. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani’s lead program, NPM-115, is a six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight patients. Vivani’s emerging pipeline includes NPM-139 (semaglutide implant), which is also under development for chronic weight management. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company’s six-month, subdermal, GLP-1 (exenatide) implant under development for the treatment of type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of oral and injectable medications. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments, face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani is confident that its highly differentiated portfolio of miniature, ultra long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. For more information, please visit: www.vivani.com. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “planned,” “positioned,” “potential,” “future,” ”allow,” “intended” and other similar expressions that are in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1™ trial and reporting of trial results, Vivani’s development plans for Vivani’s products, including NPM-115, NPM-139, NPM-119, and Vivani’s plans with respect to Cortigent, Inc. (“Cortigent”), a wholly owned subsidiary of the Company, and its proposed spin-off, technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks that the spin-off will not be completed in a timely manner or at all; risks of failure to satisfy any conditions to the spin-off; risks of failure of the spin-off to qualify for non-recognition of gain or loss for U.S. Federal Income Tax purposes, and approval with the U.S. Securities and Exchange Commission (“SEC”) and Nasdaq; uncertainty of whether the anticipated benefits of the spin-off can be achieved; risks of unexpected costs or delays; and risks and uncertainties associated with the development and commercialization of products and product candidates that may impact or alter anticipated business plans, strategies and objectives. Because forward-looking statements relate to the future, they are subject to additional inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani’s products, including NPM-115, NPM-139, and NPM-119; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical trials and the results therefrom; Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business; market conditions and the ability of Cortigent to complete its spin-off, Cortigent’s history of losses and its ability to access additional capital or otherwise fund Cortigent’s business and advance its product candidates and pre-clinical programs. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. There may be additional risks that the Company and Cortigent consider immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 31, 2025, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q and in other reports that the Company has filed with the SEC. Any forward-looking statements made by Vivani or Cortigent in this press release are based only on information currently available to the Company and Cortigent and assumptions that Vivani and Cortigent believe to be reasonable. Any forward-looking statement speaks only as of the date on which it is made. Neither the Company nor Cortigent undertake any obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time-to-time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact:Donald DwyerChief Business Officerinfo@vivani.com(415) 506-8462 Investor Relations Contact:Jami TaylorInvestor Relations Advisorinvestors@vivani.com(415) 506-8462 Media Contact:Sean LeousICR HealthcareSean.Leous@ICRHealthcare.com(646) 866-4012

高管变更

2025-06-06

·ETPharma

Roche's Tecentriq reduces recurrence, deaths for certain colon cancer patients

London: Adding Roche's immunotherapy drug Tecentriq to chemotherapy after surgery in certain patients whose colon cancer had spread to the lymph nodes led to a 50 per cent reduction in cancer recurrence and death compared to chemotherapy alone, according to trial data presented at recent medical meeting. Patients in the study had tumors with a genetic defect known as deficient DNA mismatch repair, or dMMR. About 15 per cent of colon cancer patients have dMMR tumors , which do not respond well to chemotherapy. "The findings from our study represent a major advance in the adjuvant treatment of dMMR stage 3 colon cancer and will now change the treatment for this type of cancer," study leader Dr. Frank Sinicrope of the Mayo Clinic in Rochester, Minnesota said in a statement. The data were presented at the ASCO meeting that concluded earlier this week. The trial enrolled 712 patients with dMMR stage 3 colon cancer that had been surgically removed and who had cancer cells in their lymph nodes. Half of the study participants received chemotherapy along with Tecentriq, which activates the immune system to attack and kill cancer cells, for six months, followed by the immunotherapy alone for another six months. The other half of the patients received chemotherapy for 12 months. The benefit of Tecentriq was seen even in the oldest patients and those at particularly high-risk. "It's extremely rewarding to be able to offer our patients a new treatment regimen that can reduce the risk of recurrence and improve their chances of survival," Sinicrope said. ASPIRIN MAY NOT BE BEST LONG-TERM OPTION AFTER HEART PROCEDURE As patients recover after a minimally invasive heart procedure, they might be better off continuing to take a certain type of blood-thinning drug to help prevent a heart attack or stroke, instead of continuing with the traditional aspirin, a new study suggests. Early after percutaneous coronary intervention (PCI) - a procedure to prop open blocked arteries either after a heart attack, or to prevent one - patients often receive dual anti-clotting therapy with both a P2Y12 inhibitor such as clopidogrel, the generic version of Plavix, or AstraZeneca's Brilinta (ticagrelor), and aspirin. After several months, patients are usually switched from dual therapy to lifelong daily aspirin use. But pooled data looking at patients who took part in five earlier clinical trials found that continuing to prescribe the P2Y12 inhibitors and stopping the aspirin was associated with lower rates of death, heart attack and stroke compared with continuing the aspirin, with no increased risk of major bleeding, researchers reported in The BMJ. Overall, the trials involved 16,117 patients who received either a P2Y12 inhibitor or aspirin after completing dual therapy following PCI. After an average follow-up period of around 4 years, P2Y12 inhibitor therapy was associated with a 23% lower risk of a composite of heart-related death, heart attack, or stroke, compared with aspirin, with no significant difference in major bleeding. That translates into one prevented cardiovascular death, heart attack, or stroke for every 46 patients taking a P2Y12 inhibitor instead of aspirin after dual therapy. Overall, the findings suggest that P2Y12 inhibitor drugs should be preferred over aspirin "due to reductions in major adverse cardiac and cerebrovascular events without increasing major bleeding in the medium term," according to an editorial published with the study. But the editorial said that since patients are advised to continue the post-PCI therapy for life, large trials directly comparing the different strategies with longer follow up are needed. LONG-TERM GLP-1 USE LINKED TO HIGHER RISK OF AGE-RELATED EYE DISEASE Some diabetes and weight-loss drugs from the class known as GLP-1 agonists were linked with a small but elevated risk for an age-related eye disease in patients with diabetes, according to a study published on Thursday in JAMA Ophthalmology. In 139,000 patients with diabetes, including 46,334 who had been using the GLP-1 drugs semaglutide or lixisenatide, researchers identified 181 new cases of neovascular age-related macular degeneration, also known as wet AMD. Wet AMD is a degenerative eye disease marked by the abnormal growth of blood vessels under the retina that leak fluid or blood and can lead to blindness. The risk of developing AMD during up to three years of follow-up was low, at 0.2% in GLP-1 users versus 0.1% in non-users. Still, the researchers point out, after accounting for patients' individual risk factors, the odds of AMD were doubled with at least six months of GLP-1 use and tripled in patients with the longest duration of use. Semaglutide is the active ingredient in the widely used Novo Nordisk drugs Ozempic and Wegovy, while lixisenatide is the main ingredient in Sanofi's discontinued Adlyxin. GLP-1 drugs have also been associated with higher risks for an eye condition known as nonarteritic anterior ischemic optic neuropathy, or NAION. Researchers did not have information about the dose, route of administration, or frequency of administration of the medications used in the study. Even with that information, the study could not have proved cause and effect. At least one earlier study with longer follow up reported that GLP-1 use was linked with a lower, rather than higher, risk for AMD. "Our findings are not directly contradictory" with that earlier report, said study leader Dr. Reut Shor of the University of Toronto. "Factors such as timing and duration of exposure, disease stage, and patient characteristics may all influence outcomes," Shor said. "Our results add another layer to the emerging understanding of this complex relationship and emphasize the need for further research to clarify these trends." (To receive the full newsletter in your inbox for free sign up here) (Reporting by Nancy Lapid; additional reporting by Shawana Alleyne-Morris; editing by Bill Berkrot)

临床结果免疫疗法临床研究

2025-06-06

·ETPharma

Novo's Ozempic, Wegovy linked to rare cases of dangerous eye disorder, EMA says

Bengaluru: The European Medicines Agency 's safety committee has concluded that the use of Novo Nordisk's popular weight-loss drug Wegovy and its treatments for type 2 diabetes may cause rare occurrences of a potentially dangerous eye condition. Called non-arteritic anterior ischemic optic neuropathy ( NAION ), the condition may affect up to 1 in 10,000 people taking semaglutide , the active ingredient in Wegovy and Novo's diabetes drugs Ozempic and Rybelsus, the regulator said on Friday. The EMA, which started its review in December, said the use of the drugs is linked to about twofold increase in the risk of developing the condition compared to people not taking the medicine. NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma. Studies have linked semaglutide to NAION in the past. But this is the first time a regulator has made the link. Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, which work by helping control blood sugar levels and triggering a feeling of fullness. A large study of nearly 350,000 diabetics published earlier this year had showed that the risk of developing NAION more than doubled after long-term use of semaglutide, compared to patients taking medicines from other classes. The EMA said it has reviewed all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials and post-marketing surveillance. It has recommended the drugmaker to update prescribing information for medicines containing semaglutide to include NAION as a side effect with a frequency of "very rare". The U.S. Food and Drug Administration did not immediately respond to a Reuters request for comment. (Reporting by Manas Mishra and Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)