Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint
'We are very disappointed that our study did not meet its efficacy endpoints, and our greatest regret is that people living with inflammatory bowel disease will not, for now, have the opportunity to benefit from a new treatment option,' said Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences. 'The gut microbiome is a well-recognized driver of IBD, yet remains a facet of the disease untouched by current treatments. As a field, we have not yet succeeded in making a meaningful impact for people with IBD through microbiome-based approaches, but every study moves us closer to that goal. We are committed to sharing further analyses of this study at upcoming scientific meetings to help chart new paths forward.'
'Our priority at Vedanta remains the successful execution of our ongoing global pivotal study of VE303 for the prevention of recurrent C. difficile infection, with the goal of potentially delivering the first approved Live Biotherapeutic Product in any indication — and, in doing so, addressing a serious health condition with a significant unmet medical need,' concluded Dr. Olle.
In the randomized, placebo-controlled COLLECTiVE202 study, endoscopic and clinical responses were assessed using standardized criteria, and the observed response rates in the VE202 group were not statistically different from those in the placebo group. VE202 was generally safe and well tolerated — most adverse events were mild or moderate in intensity, with no reports of treatment-related serious adverse events. Analyses of bacterial colonization, histological findings, and immune responses are ongoing and will be shared in future scientific forums.
Vedanta remains focused on advancing its other pipeline programs:
VE303: Vedanta is currently enrolling patients into RESTORATiVE303, a registrational Phase 3 study of VE303 for the prevention of recurrent C. difficile infection (rCDI) at over 200 sites in 24 countries. The Phase 3 program is supported by results from a positive Phase 2 study, in which VE303 demonstrated potentially best-in-disease efficacy with a 30.5% absolute risk reduction compared with placebo and greater than 80% reduction in the odds of a CDI recurrence.
VE707: Vedanta is also advancing VE707 to prevent infections by multidrug-resistant organisms that affect a wide range of vulnerable populations in areas such as oncology, urology, transplantation, and critical care, with IND submission planned for 1H 2026.
About the COLLECTiVE202 Study
COLLECTiVE202 is a double-blind, placebo-controlled, randomized clinical trial conducted at sites in the United States, Europe, and Australia. The study enrolled 114 patients, between the ages of 18 and 75 years, with mild-to-moderate ulcerative colitis who had not been exposed to any biologic or advanced oral therapies. Either VE202 (N=57) or placebo (N=57) was added to a patient's stable background ulcerative colitis therapy. The primary endpoints were safety and Week 8 endoscopic response (defined as a reduction of at least 1 point on the Mayo endoscopic subscore). Secondary endpoints included clinical response and remission, endoscopic improvement and remission, as well as histological assessments and measures of colonization, quality-of-life and inflammatory biomarkers. For more information on COLLECTiVE202 (NCT05370885), visit clinicaltrials.gov.
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage biopharmaceutical company developing microbiome-based oral medicines for the treatment of gastrointestinal diseases. The company's lead asset is a potential first-in-class therapy, VE303, currently in a global Phase 3 registrational trial for prevention of recurrent C. difficile infection. Vedanta leverages its proprietary industry-leading product engine to develop therapeutic drug candidates based on defined bacterial consortia. The product engine is supported by broad foundational intellectual property and spans the development lifecycle from discovery to commercialization. It includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
22 minutes ago
- Business Wire
Alpha Cognition Inc. Reports Second Quarter 2025 Financial Results and Provides Operational Update
VANCOUVER, British Columbia & GRAPEVINE, Texas--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' or the 'Company') today announced its financial results for the second quarter ended June 30, 2025. 'The initial ZUNVEYL launch has been met with strong interest from both healthcare providers and patients. Early adoption in nursing homes and by geriatric specialists has created a solid foundation for future growth,' said Michael McFadden, Chief Executive Officer of Alpha Cognition. 'Clinician feedback continues to validate our belief that ZUNVEYL will become an important therapy in the long-term care segment.' Recent Business and Operational Highlights Completed the first quarter of ZUNVEYL commercialization, achieving approximately $2 million in net product revenues year-to-date. Received positive clinician feedback highlighting ZUNVEYL's impact on cognitive function, behavioral symptoms, and its safety profile. Secured the Company's first national Medicare Part D contract with no prior authorization required, ahead of schedule. Sales team engaged with more than 3,700 healthcare professionals and generated prescriptions in over 300 nursing homes. Concluded the Bomb Blast Study, demonstrating that ALPHA-1062 reduced neuroinflammation and neuropathology associated with blast trauma. Second Quarter 2025 Financial Results: ZUNVEYL net product revenues of $1.6 million for the quarter ended June 30, 2025. Research and development expenses for the three months ended June 30, 2025 were $317 thousand compared to $967 thousand for the same period in 2024. Selling, general and administrative expenses for the three months ended June 30, 2025 were $6.5 million compared to $1.4 million for the same period in 2024, driven primarily by commercial-readiness activities. Net operating loss for the three months ended June 30, 2025 were $5.7 million compared to $2.4 million for the same period in 2024. Net loss for the for the three months ended June 30, 2025 were $10.5 million compared to $2.1 million for the same period in 2024, primarily due to a $5.2 million non-cash change in the value of warrant liabilities. Cash and cash equivalents of $39.4 million as of March 31, 2025 compared to $48.6 million as of December 31, 2024. At current utilization rate, the Company expects a cash runway of approximately two years. Following the release, management will host a conference call to review financial and operating results. About Alpha Cognition Inc. 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. ZUNVEYL is a patented drug approved as a 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 an intranasal formulation for Cognitive Impairment with mTBI. INDICATION AND USAGE ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. WARNINGS AND PRECAUTIONS Serious Skin Reactions: 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. Anesthesia: See Drug Interactions Section Cardiovascular Conditions: 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. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Gastrointestinal Conditions: 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. Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Neurological Conditions: 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. Pulmonary Conditions: 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. ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: 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. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment: 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. Renal Impairment: 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. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Forward-looking Statements 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. 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 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 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 most recent Annual Report on Form 10-K filed with the SEC on March 31, 2025 and the Company's other filings with the SEC available at 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.
Business Wire
an hour ago
- Business Wire
Syncell Announces Strategic Co-Marketing Agreement to Advance
LIVERMORE, Calif., & TAIPEI, Taiwan--(BUSINESS WIRE)-- Syncell, Inc., a pioneer in subcellular spatial proteomics, announced a strategic co-marketing agreement with Thermo Fisher Scientific to bring a fully integrated, high-resolution spatial proteomics workflow to the market. The collaboration highlights the power of integrating Syncell's proprietary Microscoop® technology for spatial protein purification with Thermo Fisher's ultra-sensitive Orbitrap™ Astral™ mass spectrometer and newly released Orbitrap™ Astral™ Zoom mass spectrometer. 'The integration of the Syncell Microscoop technology with the Astral Orbitrap mass spectrometer has transformed our capacity to interrogate biology." Share With this collaboration, Thermo Fisher and Syncell will enable researchers to implement unbiased spatial proteomics with high subcellular resolution to investigate the location and organization of proteins across tissues and cells without relying on predefined targets. This marks a major advance from traditional antibody-based spatial methods and introduces new possibilities for comprehensive protein mapping and discovery across biological systems in oncology, neuroscience, drug discovery, immunology, cell biology, and more. 'The integration of the Syncell Microscoop technology with the Astral Orbitrap mass spectrometer has transformed our capacity to interrogate biology,' said Luisa Iruela-Arispe, PhD, chair of the Department of Cell and Developmental Biology at the Northwestern Medicine Feinberg School of Medicine. 'By uniting the nanometer-scale spatial resolution of the Syncell Microscoop technology with the ultra-sensitive detection of the Astral mass spectrometer, we have achieved an analytical capability that pushes the boundaries of cell signaling, revealing spatial and chemical detail that has never before been accessible.' The combined workflow integrates Syncell's Microscoop Mint — a high-precision system that performs real-time, microscopy-guided spatial protein purification — with the Orbitrap Astral mass spectrometer series, delivering unmatched acquisition speed, proteome depth, and spatial resolution. Together, these technologies unlock a hypothesis-free approach to subcellular proteome analysis in fresh and formalin-fixed, paraffin-embedded (FFPE) tissues as well as in cell culture samples. 'This collaboration with Thermo Fisher reinforces our mission to democratize access to high-resolution, unbiased spatial proteomics,' said Jung-Chi Liao, PhD, CEO and founder at Syncell. 'Microscoop's spatial purification technology is an excellent match with Thermo Fisher's Orbitrap Astral mass spectrometer series. By integrating our systems, we are setting a new gold standard for high-resolution proteomic discovery at the cellular and subcellular level.' About Syncell Syncell is a commercial-stage life science company focused on subcellular protein purification and unbiased spatial proteomics analysis. Syncell has commercialized its Microscoop® technology, helping researchers accurately discover new protein components from targeted regions of interest. To date, the company has raised $40 million from investors. To learn more, visit or follow us on Linkedin.
Business Wire
an hour ago
- Business Wire
Applauds Florida's Emergency Ban on Synthetic 7-OH, Reinforces Commitment to Safe, Natural Kratom
PHOENIX--(BUSINESS WIRE)--VIVAZEN ®, a leading botanical wellness brand, today praised the Florida Attorney General's emergency scheduling of synthetic 7-hydroxymitragynine (7-OH), calling the targeted action a public health win that protects consumers while preserving access to responsibly formulated kratom products. 'We welcome oversight that distinguishes real kratom from harmful counterfeits and synthetics,' said Curtis. 'Florida's action should be a national blueprint.' Share 7-OH at concentrations above 1% by total weight to Schedule I of Florida's controlled substances list. Crucially, the rule clarifies that 'This designation does not apply to mitragynine,' the naturally occurring alkaloid found in kratom leaf. This distinction mirrors recent federal recommendations to classify synthetic 7-OH, not kratom, as a Schedule I substance. 'Florida got this exactly right,' said Steve Curtis, CEO of VIVAZEN ®. 'Synthetic 7-OH is a chemically manipulated derivative with opioid-like risks. By targeting the synthetic drug without criminalizing the natural plant, Florida is protecting consumers and advancing a model of science-based regulation.' VIVAZEN ® has long advocated for regulatory clarity and quality assurance across the botanical category. All VIVAZEN ® products are derived from natural kratom leaf and extract, with no synthetic additives. As part of its quality commitment, VIVAZEN ® proactively tests every batch for 7-OH and confirms it is not detected. 'Every product we release undergoes rigorous third-party testing for alkaloid profile, microbial safety, heavy metals, and adulterants,' added Curtis. 'That includes routine testing for 7-OH, even though we don't use it. It's about trust.' This announcement comes amid heightened national concern over unregulated synthetic 7-OH. VIVAZEN ® supports state-level Kratom Consumer Protection Acts (KCPAs) and is actively involved in real-world evidence (RWE) studies to evaluate kratom's benefits in daily use. 'We welcome oversight that distinguishes real kratom from harmful counterfeits and synthetics,' said Curtis. 'Florida's action should be a national blueprint.'
