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Business Wire
12 hours ago
- Business Wire
Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vedanta Biosciences, a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for gastrointestinal diseases, today announced that its candidate VE202 did not meet the primary endpoint of endoscopic response in the Phase 2 COLLECTiVE202 study for the treatment of patients with mild-to-moderate ulcerative colitis (UC). '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 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.
Medscape
2 days ago
- Medscape
Diet Rich in Ultraprocessed Grains Ups Risk for IBD
Diets high in packaged breads, cookies, and other highly processed grain products may raise the risk for inflammatory bowel disease (IBD), while minimally processed grain products may offer some protection, a large study has found. The sweeping analysis of 124,590 adults from 21 countries found that those eating at least 19 g of ultraprocessed grains a day were about twice as likely to be diagnosed with IBD as peers eating less than 9 g daily. 'Our study adds robust evidence from a large, diverse global cohort that frequent consumption of ultraprocessed grains is associated with an increased risk of developing inflammatory bowel disease,' Neeraj Narula, MD, MPH, gastroenterologist and associate professor of medicine, McMaster University, Hamilton, Ontario, Canada, told Medscape Medical News. The study also 'further clarifies that not all grains carry risk — minimally processed grains like fresh bread and rice were associated with lower risk even. These results build on and specify previous findings linking ultraprocessed foods more broadly to IBD,' Narula said. The study was published online on August 4 in The American Journal of Gastroenterology. Diet Matters to IBD Risk According to the latest US data (2021-2023), ultraprocessed foods made up 62% of daily calories for young people and 53% for adults in 2021-2023. The Prospective Urban Rural Epidemiology (PURE) study has followed participants aged 35-70 years for a median of nearly 13 years. At enrollment, volunteers completed country-specific food-frequency questionnaires, enabling researchers to quantify usual intake of more than 130 food items and track new cases of IBD reported at biennial follow-ups. The researchers classified packaged breads, sweet breakfast cereals, crackers, pastries and ready-to-heat pizza or pasta as ultraprocessed grains because they are refined and typically contain additives such as emulsifiers and preservatives. Fresh bakery bread and plain rice were analyzed separately as minimally processed grain references. During a median of 12.9 years, 605 participants developed IBD; 497 developed ulcerative colitis (UC) and 108 developed Crohn's disease. Increased intake of ultraprocessed grains was associated with a higher risk for IBD, with hazard ratios (HR) of 2.08 for intake of ≥ 50 g/d and 1.37 for 19-50 g/d compared to intake of < 19 g/d. The increased risk was largely driven by a significantly increased risk for UC (HR, 2.46) and not Crohn's disease (HR, 0.98). Among the different ultraprocessed grain products, packaged bread stood out: Consuming ≥ 30 g/d of packaged bread (a little more than one slice) was associated with a greater than twofold increased risk for IBD (HR, 2.11) compared to no intake of packaged bread. In contrast, greater consumption of fresh bread was associated with a reduced risk of developing IBD (HR, 0.61 for ≥ 65 g/d and 0.45 for 16-65 g/d compared to < 16 g/d). Increased intake of rice was also associated with a lower risk of developing IBD (HR, 0.63 for ≥ 1 serving/d and 0.99 for < 1 serving/d). When the researchers widened the lens to all ultraprocessed foods — from sodas to salty snacks — the risk for IBD climbed further. Participants eating at least five servings a day had nearly a fourfold greater odds of IBD than those eating fewer than one serving (HR, 3.95) — a finding consistent with other data from the PURE study cohort. What to Tell Patients? The authors acknowledged in their paper that it's difficult — if not impossible — to completely avoid ultraprocessed food in the Western diet. They said their findings support 'public health strategies to promote consumption of whole and minimally processed foods while reducing the consumption of highly processed alternatives.' 'I tell my patients that emerging literature shows an association between ultraprocessed food intake and IBD risk, but it's not yet clear whether simply cutting out those foods will improve disease activity once IBD is established,' Narula told Medscape Medical News . 'However, I still encourage patients to reduce ultraprocessed foods and to follow a Mediterranean-style diet — focusing on minimally processed grains, fruits, vegetables, healthy fats, and lean proteins — to support overall gut and general health,' Narula said. Reached for comment, Ashwin Ananthkrishnan, MD, MPH, associate professor of medicine, Massachusetts General Hospital, Boston, who wasn't part of the study, said it 'adds incrementally to the growing data on how ultraprocessed foods may affect the risk of IBD.' 'They (and others) have previously shown a link between general ultraprocessed food consumption and risk of IBD. Others have shown that some of this is mediated through refined grains. This study more specifically studies that question and demonstrates an association,' said Ananthkrishnan. 'This should not be used, however, to counsel patients. It does not study the impact of grain intake on patients with IBD. It may help inform population level preventive strategies (or in high-risk individuals) but requires more confirmation since there is significant heterogeneity between the various countries in this cohort. Countries that have high refined grain intake are also enriched in several other IBD risk factors (including genetics),' Ananthkrishnan told Medscape Medical News .
Yahoo
04-08-2025
- Yahoo
HCA Healthcare, Inc. (HCA): A Bull Case Theory
We came across a bullish thesis on HCA Healthcare, Inc. on Valueinvesting subreddit by DividendKing47. In this article, we will summarize the bulls' thesis on HCA. HCA Healthcare, Inc.'s share was trading at $334.32 as of July 25th. HCA's trailing and forward P/E were 14.04 and 13.32 respectively according to Yahoo Finance. A successful healthcare provider smiling confidently in a modern hospital facility. HCA Healthcare, the largest U.S. hospital operator, manages 190 hospitals nationwide and plans to expand further with $5.0–5.2 billion in 2025 capital expenditures to meet growing healthcare demand. Benefiting from a healthcare services industry projected to grow at a 4.9% CAGR through 2029, HCA targets raising its 27% market share to 29% by 2030. Its 2024 revenue reached $70.6 billion, with 2025 guidance of $74–76 billion, implying 6.2% growth at the midpoint, supported by $10.5 billion in free cash flow and a $140 billion enterprise value. Growth will be driven by facility upgrades, outpatient services expansion, and technological integration, including EHRs and AI-enabled diagnostics, enhancing efficiency and patient outcomes. HCA's strategic pivot toward outpatient care, alongside modernization of existing hospitals, positions it to capture an aging population's increasing needs while mitigating inpatient reimbursement risks. Consolidation trends favor HCA's acquisition-led growth, though competitive pressures from peers like Tenet Healthcare and Universal Health Services remain. A conservative DCF analysis, using a 9% WACC and 1.25% terminal growth, values the enterprise at $167 billion, with equity of $127.5 billion or $529.79 per share—representing 58.5% upside. Risks include regulatory changes, labor shortages, and public scrutiny that could pressure margins and volumes, as well as macroeconomic headwinds that may delay elective procedures. Nonetheless, HCA's scale, robust free cash generation, and focus on operational efficiency offer resilience. Even amid industry headwinds, its expansion strategy and strong positioning provide an attractive investment opportunity, with substantial upside potential underpinned by conservative growth assumptions and disciplined capital allocation. Previously, we covered a bullish thesis on Tenet Healthcare Corporation (THC) by BlackSwanInvestor in December 2024, which highlighted operational streamlining, debt reduction, and the rapid expansion of its high-margin Ambulatory Care segment. The company's stock price has appreciated by approximately 21.7% since our coverage, as the thesis played out. The thesis still stands as Ambulatory Care growth drives value creation. DividendKing47 shares a similar view but emphasizes HCA Healthcare's scale-driven expansion and capital allocation in the same healthcare services market. HCA Healthcare, Inc. is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 74 hedge fund portfolios held HCA at the end of the first quarter which was 81 in the previous quarter. While we acknowledge the potential of HCA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None.
