Enanta Pharmaceuticals Announces Data from its Phase 2 Study of Zelicapavir in Children with Respiratory Syncytial Virus to be Presented at the 43rd Annual ESPID Meeting
WATERTOWN, Mass.--(BUSINESS WIRE)--May 22, 2025--
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that data from the Company's Phase 2 study of zelicapavir in young children infected with respiratory syncytial virus (RSV) will be available as an E-Poster at the 43 rd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) 2025, being held May 26-30, 2025 at the Bucharest International Conference Centre in Bucharest, Romania and online.
The E-Poster will highlight results from a Phase 2 study of zelicapavir, an oral, non-nucleoside small-molecule RSV-replication-inhibitor (N-protein), which were announced in December 2024, and include new data on the population PK/PD and time to viral load negativity.
E-Poster Title : 'Antiviral Treatment of RSV in Children: Virology and PK Results of a Randomized Double-Blind Placebo-Controlled International Trial of Zelicapavir (EDP-938)'
E-Poster Number : ID 1767
Date and Time : Available starting on May 26, 2025, at 8:00 a.m. Eastern European Summer Time/ 1:00 a.m. Eastern Daylight Time
E-Poster Location : Level 0, Main Floor or on the conference portal and the conference app
Presenter : John DeVincenzo, M.D.
A copy of the E-Poster will be available on Enanta's website here . The scientific program for ESPID 2025 can be found here .
About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta's clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition.
Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET ® (U.S.) and MAVIRET ® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta's royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta's operations. Please visit www.enanta.com for more information.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250522937132/en/
CONTACT: Media and Investor
Jennifer Viera
617-744-3848
[email protected]
KEYWORD: EUROPE ROMANIA UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: HEALTH INFECTIOUS DISEASES CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY
SOURCE: Enanta Pharmaceuticals, Inc.
Copyright Business Wire 2025.
PUB: 05/22/2025 07:00 AM/DISC: 05/22/2025 06:59 AM
http://www.businesswire.com/news/home/20250522937132/en
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
10 hours ago
- Yahoo
Coherus BioSciences, Inc. (CHRS): A Bull Case Theory
We came across a bullish thesis on Coherus BioSciences, Inc. (CHRS) on Steve Wagner's Substack. In this article, we will summarize the bulls' thesis on CHRS. Coherus BioSciences, Inc. (CHRS)'s share was trading at $0.77 as of 30th May. CHRS's trailing P/E was 1.77 according to Yahoo Finance. Scientist in a lab working on a research project, focusing on biotechnology and healthcare advancements. Coherus BioSciences (CHRS), long overlooked by Wall Street, is taking a bold step into innovative oncology by partnering with UK-based STORM Therapeutics to test a novel cancer treatment strategy. The collaboration brings together Coherus's immunotherapy toripalimab (LOQTORZI) and STORM's first-in-class RNA-modifying enzyme inhibitor STC-15 in a Phase 1b/2 clinical trial. This unexpected pairing represents a fresh approach to immuno-oncology, targeting cancer through dual mechanisms that could produce synergistic effects. Toripalimab, already approved in the U.S. for nasopharyngeal carcinoma and under review for broader indications, offers proven checkpoint inhibition, while STC-15 introduces a cutting-edge method of disrupting RNA methylation processes linked to tumor growth and immune evasion. If this combo demonstrates efficacy, it could represent a completely new class of cancer therapy and place Coherus at the forefront of next-generation immuno-oncology innovation. Importantly, this partnership shows strategic vision from CHRS's management as they seek to differentiate the company beyond biosimilars and move deeper into proprietary immunotherapy. With the trial still in early stages and little market attention so far, the risk/reward profile for investors is potentially skewed to the upside. Should the data prove positive, the impact could be significant for both companies, especially for CHRS as it repositions itself as a serious player in oncology innovation. This under-the-radar development deserves close monitoring, as it could catalyze a major reevaluation of Coherus's valuation and growth trajectory. Previously, we have covered CHRS in March 2025 wherein we summarized a by the same author. Coherus BioSciences (CHRS) posted a strong turnaround in 2024 with $267M in revenue and $28.5M net income, driven by Loqtorzi's growth and the planned $250M Udenyca divestiture. The company pivoted fully to oncology, trimmed costs, and advanced its pipeline, yet management expressed frustration over the stock's undervaluation, hinting at potential M&A. Since our last coverage, the stock is down 38% as of 30th May. We don't trust CHRS' management as the stock lost more than 95% of its value in recent years and is still losing a ton of money. The market agrees with us and thinks this stock is going to go bankrupt. We believe CHRS should stop wasting shareholder's money, sell valuable assets, and liquidate the company. We don't think that's a likely outcome. Coherus BioSciences, Inc. (CHRS) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 10 hedge fund portfolios held CHRS at the end of the first quarter which was 10 in the previous quarter. While we acknowledge the potential of CHRS as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, 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. This article was originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
a day ago
- Yahoo
RenovoRx (RNXT) PT Raised to $11.50 by Ascendiant on Strong Q1 2025 Results
On Thursday, Ascendiant analyst Edward Woo raised the price target on RenovoRx Inc. (NASDAQ:RNXT) to $11.50 from $11, while maintaining a Buy rating on the shares. This adjustment follows the company's strong revenue growth reported in its Q1 2025 results. Woo indicated that the commercialization of RenovoCath and anticipated positive clinical data in Q3 will serve as strong catalysts for the stock. A clinical researcher in a lab examining a new biopharmaceutical product. The Q1 result includes ~$200K in revenue from commercial sales of RenovoCath alone. RenovoCath is an FDA-cleared and dual-balloon catheter device for the targeted isolation of blood flow and delivery of fluids. R&D expenses increased to $1.7 million, up from $1.3 million in Q1 2024, which was driven by higher employee compensation and manufacturing costs during the quarter. The company's Phase 3 TIGeR-PaC clinical trial showed promising results, with patients experiencing a median overall survival of 16 months using their targeted approach compared to 10 months with standard chemotherapy. There was also a 65% reduction in adverse events like nausea and fatigue. This trial is evaluating the company's proprietary TAMP therapy platform for the treatment of Locally Advanced Pancreatic Cancer. RenovoRx Inc. (NASDAQ:RNXT) is a clinical-stage biopharmaceutical company that develops targeted combination therapies to enhance therapeutic outcomes for cancer patients undergoing treatment. While we acknowledge the potential of RNXT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
2 days ago
- Medscape
Sibeprenlimab Halves uPCR in IgA Nephropathy Trial
VIENNA — Sibeprenlimab, a novel selective immune antibody, reduced the urine protein-to-creatinine ratio (uPCR) by more than half in patients with immunoglobulin A (IgA) nephropathy, according to an interim analysis of the VISIONARY trial. Beyond this clinical effect, a notable observation was the lack of safety concerns, especially given that, although sibeprenlimab is a selective agent, there may have been unexpected off-target effects. 'Safety's been a key consideration with these drugs,' study presenter Vlado Perkovic, MD, PhD, provost and scientia professor, University of New South Wales, Sydney, Australia, told Medscape Medical News . Sibeprenlimab represents a new mechanism of action and 'we don't yet fully understand the profile, so we've been looking at that data very carefully,' explained Perkovic. 'In particular, the infection risk has been my biggest concern, given we know that infections are dramatically increased in people with steroid therapy for example, in IgA nephropathy.' The results of the trial — the largest to date in the field — were presented at the 62nd European Renal Association Congress 2025 on June 6 and drew a warm applause from the audience. An Underestimated Condition IgA nephropathy is estimated to affect 2.5 per 100,000 people per year, although 'it's possible that that number is a significant underestimate,' said Perkovic. Diagnosis typically occurs between 20 and 40 years of age. And, despite supportive care, the majority of patients have a high lifetime risk of end-stage kidney disease (ESKD), with up to 50% of patients progressing to ESKD within 20 years of their clinical presentation. 'It's quite likely we've underestimated just how important this condition is,' said Perkovic, but 'we're fortunate that we're in the middle of something of a golden age of developing new treatments.' A number of therapies have been shown to reduce the risks associated with the disease, although they do not necessarily address the immunological basis of the condition. In addition to newer treatments, 'corticosteroids have long been used for people with IgA nephropathy,' Perkovic said, 'but of course, corticosteroids also have a range of different effects across the immune system,' which can lead to adverse outcomes. Sibeprenlimab is a selective IgG2 antibody that binds to and inhibits the biological activity of APRIL (a proliferation-inducing ligand), which is produced by mucosal epithelial and myeloid cells and binds to B cells. APRIL regulates B-cell-mediated immune responses and mediates IgG and IgA class switching in mature B cells. It is these two actions that make APRIL a key factor in the so-called 4-Hit process in the pathogenesis of IgA nephropathy, which results in the deposition of immune complexes in the glomerulus, leading to proteinuria and loss of kidney function. Phase 3 VISIONARY TRIAL Following on from the successful phase 2 ENVISION trial of sibeprenlimab, the researchers undertook the phase 3 VISIONARY trial, an ongoing study involving patients with biopsy-confirmed IgA nephropathy from 240 sites in 31 countries, who were randomized to sibeprenlimab or placebo for 100 weeks and followed up for a further 12 weeks. All patients were required to have a uPCR of ≥ 0.75 g/g or urine protein excretion of ≥ 1.0 g/day, an estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m2, and to have been on a stable dose of either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, with or without a SGLT2 inhibitor, for ≥ 3 months prior to screening. For the current pre-specified interim analysis, Perkovic reported the efficacy and safety results in the first 320 randomized patients (152 in the sibeprenlimab group and 168 in the placebo group), focusing on the primary endpoint of 24-hour uPCR at 9 months vs baseline, with eGFR and other data expected to be presented in 2026. The median age of the patients was 42-43 years. There were proportionally fewer females in the sibeprenlimab group (34.2%) vs the placebo group (40.5%). The majority of the patients were Asian, at 61.8% and 56.5%, respectively. Compared with a rise in uPCR at the 9-month follow-up in the placebo group, sibeprenlimab was associated with a 50.2% reduction in uPCR, giving a highly significant placebo-adjusted treatment effect of 51.2% ( P < .0001). Importantly, the benefit of sibeprenlimab on uPCR was seen as early as 4 weeks after initiating treatment and continued to accrue throughout follow-up. Ronald T. Gansevoort, MD, PhD, professor of medicine and a nephrologist at the Department of Nephrology, University Medical Center Groningen, Netherlands, who co-chaired the session, told Medscape Medical News that the results look 'very promising.' 'Recently, we have had several agents working in different ways that all show proteinuria lowering,' he continued, but the results from those studies show that the improvements seen in VISIONARY are 'the best proteinuria lowering' seen so far. Gansevoort noted, however, that this remains an interim analysis, and that he is really looking forward to seeing the kidney function results, adding: 'It was a little bit of a pity that they were not allowed to show at least the 9-month interim data on kidney function, which would have been so interesting.' Safety Results In terms of safety, the proportion of patients experiencing a treatment-related treatment-emergent adverse event (TEAE) was marginally lower with sibeprenlimab, at 32.9% vs 31.0% with placebo. The proportion of patients having a TEAE that led to treatment discontinuation was 0.7% vs 2.4%, respectively, and there were fewer severe and serious TEAEs with the experimental drug. 'If we focus on the infection-related adverse events,' Perkovic said, 'we can see that rates were numerically slightly higher in the sibeprenlimab than the placebo group, with a pattern that was broadly consistent, but with perhaps a slight excess of COVID 19.' He noted that this was 'the reverse of the pattern we've seen in the phase 2 trials, suggesting a chance' outcome. 'The data so far look remarkably encouraging,' he added. There's really no suggestion of an increased risk of infection,' with no opportunistic infections identified, 'and certainly no deaths.' More data is required from the ongoing follow-up to support what has been observed so far, but if the final results do bear out both the efficacy and safety outcome, it will show that sibeprenlimab is 'a precision approach to the fundamental abnormality in IgA nephropathy: that's the really exciting part,' said Perkovic. The study was funded by Otsuka Pharmaceutical Development and Commercialization. Perkovic declares relationships with Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Chinook Therapeutics, Eli Lilly & Company, Gilead Sciences, GlaxoSmithKline, Guard Therapeutics, Incyte, Janssen, Merck, Mitsubishi Tanabe Pharma, Mundipharma, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi, Shaanxi Micot Technology, Travere Therapeutics.
