Latest news with #CORAL
Yahoo
7 days ago
- Business
- Yahoo
Trevi Therapeutics Announces Positive Topline Results from the Phase 2b CORAL Trial of Haduvio in Patients with Idiopathic Pulmonary Fibrosis Chronic Cough
Haduvio met the primary endpoint with statistically-significant reductions in 24-hour cough frequency across all dose groups (108 and 54 mg BID p<0.0001; 27 mg BID p<0.01); a -43.3% placebo-adjusted change from Baseline was achieved at the 108 mg BID dose group Patients saw a rapid reduction in 24-hour cough frequency at Week 2, the first time point measured Haduvio was generally well-tolerated at all doses; discontinuation rates due to adverse events were similar in the Haduvio and placebo groups, 5.6% and 5.0%, respectively Trevi plans to request an End-of-Phase 2 meeting with the FDA later this year and is planning to initiate the Phase 3 program in the first half of 2026 Company to host a conference call and webcast today at 8:30 a.m. ET and will be joined by the study's UK Lead Investigator, Professor Philip Molyneaux NEW HAVEN, Conn., June 2, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), is pleased to announce today positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF (N=165). The primary endpoint in the CORAL trial was achieved, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at Week 6. The 108 mg BID, 54 mg BID and 27 mg BID dose groups achieved reductions from Baseline of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01), respectively, compared to a placebo reduction from Baseline of 16.9%1. Statistically significant improvements were observed across secondary endpoints at Week 6 in the 108 mg BID and 54 mg BID dose groups. "The CORAL trial is the first positive Phase 2b parallel group study for the treatment of chronic cough in patients with IPF, a significant milestone for patients and Trevi," said Jennifer Good, President and CEO of Trevi Therapeutics. "Chronic cough is one of the most debilitating comorbidities for patients with IPF, impacting an estimated 85% of these patients. There are no approved therapies for chronic cough in this population and with these data, Trevi is one step closer to addressing this unmet need." "In my patients with IPF, chronic cough is one of the most challenging comorbidities I face clinically," said Philip Molyneaux, MD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London. "IPF treatments focus on slowing disease progression but have not shown benefit on chronic cough, which can lead to poor health outcomes and quality of life. I am excited about the CORAL data and the potential continued development of nalbuphine ER for this significant unmet need among IPF patients." Primary Endpoint – Relative Change from Baseline in 24-hour Cough Frequency (coughs per hour) at Week 6Placebo1 (N=39) Haduvio 27 mg BID (N=42) Haduvio 54 mg BID (N=43) Haduvio 108 mg BID (N=40) Baseline 24-hour Cough Frequency (coughs/hour) 29.4 24.6 28.0 31.5 Relative Change from Baseline in 24-hour Cough Frequency at Week 6 -16.9 % -47.9% (p<0.01) -53.4% (p<0.0001) -60.2% (p<0.0001) Placebo-adjusted difference - -30.9 % -36.5 % -43.3 %1One placebo patient with an extreme outlier value at Week 6 was excluded from the modified intent-to-treat (mITT) population. Inclusion of the patient in the placebo group would have resulted in an increased cough frequency from Baseline in the placebo group and much greater placebo-adjusted differences. The primary efficacy endpoint was the relative change in objective 24-hour cough frequency (coughs per hour) for the mITT population at the end of Week 6 versus Baseline for Haduvio compared to placebo. The mITT population consists of all randomized patients who received at least one dose of study drug or placebo. Additional Trial Results A rapid reduction was seen in 24-hour cough frequency at Week 2 with Haduvio, the first time point measured. A 50% reduction in 24-hour cough frequency at Week 6 vs Baseline was seen in 65% of patients on 108 mg BID Haduvio (p<0.001), 63% of patients on 54 mg BID Haduvio (p<0.001) and 60% of patients on 27 mg BID Haduvio (p<0.001) dose groups, compared to 19% of placebo patients. A statistically-significant response was observed on the cough-severity numerical rating scale (CS-NRS), a secondary endpoint, at Week 6 on Haduvio in both the 108 mg BID and 54 mg BID dose groups. There was a mean reduction on a 0 – 10 scale of 3.0 points on the 108 mg BID (p<0.05), 3.2 points on the 54 mg BID (p<0.01) and 2.0 points on the 27 mg BID (p=0.46) dose groups compared to a 1.5-point reduction on placebo at Week 6. The 108 mg BID and 54 mg BID dose groups were statistically-significant (p<0.01) on the patient-reported outcome E-RS®: IPF Cough Subscale, a secondary endpoint, with mean relative change from Baseline of -42.4% and -43.1%, respectively at Week 6, compared to -23% for those on placebo at Week 6. The 27 mg BID dose group was not statistically-significant with a mean relative change from Baseline of –31.6%. Discontinuation rates due to adverse events were similar in the combined Haduvio groups (5.6%) and placebo group (5.0%). The safety profile observed in the trial was generally consistent with the known safety profile of Haduvio from previous trials. The most common adverse events experienced included: nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth. Serious adverse events (all non-fatal) were reported for four patients (10.0%) in the placebo group and for two patients (1.6%) across all Haduvio doses combined. James Cassella, Ph.D., Chief Development Officer of Trevi Therapeutics added, "We are very pleased with the findings from the CORAL trial, which continue to demonstrate the robust cough suppressant activity of nalbuphine ER. The study has provided critical dose-ranging data to inform the planning of our Phase 3 program. We intend to request an End-of-Phase 2 meeting with the FDA to discuss our plans for initiating the Phase 3 program for the treatment of chronic cough in patients with IPF. I would like to take the opportunity to thank the patients, investigators and site staff for moving research forward for these patients. We look forward to advancing development of this program." Conference Call/Webcast The Company will host a conference call and webcast to review the topline results today, June 2nd, at 8:30 a.m. ET. The live webcast, including audio and presentation slides, will be accessible at the time of the meeting and can be accessed here. To participate in the live conference call by phone, please dial (877) 870 4263 (domestic) or (412) 317 0790 (international) and ask to join the Trevi Therapeutics call. No code is necessary for access. An archived replay of the webcast will also be available for 30 days on the Company's website following the event. About the CORAL TrialThe Phase 2b Cough Reduction in IPF with Nalbuphine ER (CORAL) trial was a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27 mg, 54 mg, and 108 mg twice daily) compared to placebo for the treatment of chronic cough in patients with IPF over a 6-week treatment period. 165 patients with IPF chronic cough were randomized 1:1:1:1 to one of three Haduvio doses or placebo with an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial was the relative change in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for the modified intent-to-treat (mITT) population at the end of Week 6 versus Baseline for Haduvio compared to placebo. The mITT population consisted of all patients who were randomized and received at least one dose of study drug or placebo. About Idiopathic Pulmonary Fibrosis (IPF) Chronic CoughChronic cough is a highly prevalent condition in patients with IPF, impacting up to 85% of the IPF population. There are ~140,000 patients in the U.S. with IPF. The impact of chronic cough is significant with patients coughing up to 1,500 times per day. This consistent cough and any associated damage may lead to worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in patients with IPF and current off-label treatment options provide minimal benefit to patients. About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials of patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit and follow Trevi on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended March 31, 2025 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Jonathan CarlsonTrevi Therapeutics, Inc.(203) 654 3286carlsonj@ Media Contact Rosalia Scampoli914-815-1465rscampoli@ 2Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis as collected in the EXACT® (EXAcerbation of Chronic pulmonary disease Tool). EXACT© 2013, Evidera, Inc. All rights reserved. View original content to download multimedia: SOURCE Trevi Therapeutics, Inc. 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
New Indian Express
25-04-2025
- Science
- New Indian Express
Ozone pollution puts essential crops in peril, reveals new study
The world's essential food grains wheat, rice and maize are facing a silent threat from escalating surface ozone pollution. A groundbreaking study by Professor Jayanarayanan Kuttippurath and his team at the Centre for Ocean, River, Atmosphere and Land Sciences (CORAL), IIT Kharagpur, has sounded the alarm on a growing but under-recognised threat to India's food security: surface ozone pollution. Published in the journal Environmental Research, the study titled 'Surface ozone pollution-driven risks for the yield of major food crops under future climate change scenarios in India' combines historical trends with future projections using data from the Coupled Model Intercomparison Project Phase-6 (CMIP6). According to the researchers, potential oxidant surface ozone is increasingly damaging crop productivity by infiltrating plant tissues and disrupting essential physiological functions, particularly photosynthesis. Under high-emission scenarios like SSP3-7.0 and SSP5-8.5, wheat yields could decline by up to 20, while rice and maize could see losses of around 7% each after 2050. The Indo-Gangetic Plain and Central India are identified as especially vulnerable, with ozone exposure during crop growth stages potentially exceeding safe limits by up to six times. The threat is compounded by what the study refers to as a 'climate penalty' during India's rabi and post-kharif seasons, which is expected to worsen surface ozone levels. Stating that the situation is deeply concerning, the study noted that findings have significant implications for our agricultural productivity and our progress toward the United Nations Sustainable Development Goals of zero hunger and no poverty. Despite the launch of the National Clean Air Programme (NCAP) to tackle urban air pollution, agricultural regions continue to be overlooked. The study stresses the urgent need for crop-specific air quality policies and the promotion of clean energy and low-emission farming techniques. The research also explores biological mechanisms of ozone damage, noting that about 45% of surface ozone is absorbed through plant stomata, generating harmful reactive oxygen species that degrade critical enzymes such as RuBisCO. This disruption in photosynthesis reduces crop yields significantly. While several previous studies in India have used short-term data to estimate yield loss from ozone exposure, this study stands out for its comprehensive assessment of future scenarios. It urges policymakers to transition from high-emission development pathways to more sustainable models such as SSP1-2.6, which could help limit crop damage and preserve national and global food security. As India remains a major exporter of food grains to Asia and Africa, any significant loss in agricultural output could have global repercussions. The researchers call for immediate and coordinated actions to integrate air quality management into agricultural policy frameworks.
Forbes
21-04-2025
- Entertainment
- Forbes
NYT Mini Crossword Hints, Clues And Answers For Monday, April 21
Answers for today's NYT Mini Crossword are just ahead. In case you missed Sunday's NYT Mini, you can find the answers here: Wondering what the beaklike teeth of a parrotfish are used to bite? Not sure which animator drew Bugs Bunny and Daffy Duck? Don't worry, because I'm here to help you with some extra clues and the answers for today's NYT Mini crossword. The NYT Mini is a quick and dirty version of the newspaper's larger and long-running crossword. Most days, there are between three and five clues in each direction on a five by five grid, but the puzzles are sometimes larger, especially on Saturdays. Unlike its larger sibling, the NYT Mini crossword is free to play on the New York Times website or NYT Games app. However, you'll need an NYT Games subscription to access previous puzzles in the archives. To help you avoid getting stuck and having to reveal missing letters, here are the NYT Mini Crossword hints, clues and answers for Monday, April 20. Spoilers lie ahead, so remember to scroll slowly: 1 Across: Type of reef that can form an atoll 6 Across: As _____, so below 7 Across: Popular Japanese dish that has broth and often a marinated egg 8 Across: Like the kinds of phones that Apple and Samsung make 9 Across: Some, without specifics 1 Down: Pixar series with Lightning McQueen as the main character 2 Down: 44 of 47 3 Down: Times New _____ 4 Down: It's _____ Merry Muppet Christmas Movie 5 Down: The 40 days before Easter Sunday 1 Across: What the beaklike teeth of a parrotfish are used to bite – CORAL 6 Across: On top of – ABOVE 7 Across: Noodle soup with "tonkotsu" and "shoyu" varieties – RAMEN 8 Across: Sharp as a tack – SMART 9 Across: "___ questions?" – ANY 1 Down: Dealership choices – CARS 2 Down: His presidential center is being built on Chicago's South Side – OBAMA 3 Down: Like Caesar and Cicero – ROMAN 4 Down: Tex ___, animator who drew Bugs Bunny and Daffy Duck – AVERY 5 Down: Gave for a short time – LENT Completed New York Times Mini crossword for Monday, April 20 It took me 0:32 to complete today's NYT Mini. A pretty easy one for me today. I didn't know the CORAL answer and SMART didn't click on my first pass, but I knew the rest of the Across answers. I did figure out all of the Down answers on my first attempt. See you tomorrow for more NYT Mini fun! Make sure to follow my blog for more coverage of the NYT Mini and other word games, as well as video game news, insights and analysis. It helps me out a lot! Want to chat about the Mini, Connections and other NYT games? Join my Discord community!
Yahoo
19-03-2025
- Business
- Yahoo
Trevi Therapeutics Inc (TRVI) Q4 2024 Earnings Call Highlights: Navigating Losses and Advancing ...
Net Loss: $11.4 million for Q4 2024, compared to $7.8 million in Q4 2023. R&D Expenses: $9.3 million in Q4 2024, up from $6.5 million in Q4 2023. G&A Expenses: $2.9 million in Q4 2024, compared to $2.4 million in Q4 2023. Cash, Cash Equivalents, and Marketable Securities: $107.6 million as of December 31, 2024. Cash Burn Guidance: Expected $12 million to $14 million per quarter in Q1 and Q2 2025. Fully Diluted Shares Outstanding: Approximately 137 million, including 10 million stock options. Warning! GuruFocus has detected 4 Warning Signs with TRVI. Release Date: March 18, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Trevi Therapeutics Inc (NASDAQ:TRVI) reported three positive data readouts in 2024, including the Human Abuse Potential study, the CORAL study in chronic cough patients with IPF, and the RIVER study in patients with refractory chronic cough. The company successfully conducted trials across 11 countries and approximately 75 different sites, demonstrating strong execution and commitment to high-quality trials. The Human Abuse Potential study showed statistically significant lower relative drug liking for nalbuphine doses compared to butorphanol, supporting its safety profile. The Phase 2a RIVER trial met its primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, showing promise for Haduvio in treating RCC. Trevi Therapeutics Inc (NASDAQ:TRVI) has a strong cash position with $107.6 million in cash, cash equivalents, and marketable securities, providing a cash runway into the second half of 2026. Trevi Therapeutics Inc (NASDAQ:TRVI) reported a net loss of $11.4 million for the fourth quarter of 2024, an increase from the $7.8 million loss in the same quarter of 2023. Research and development expenses increased significantly to $9.3 million during the fourth quarter of 2024, primarily due to increased clinical trial costs. General and administrative expenses also rose to $2.9 million during the fourth quarter of 2024, driven by increased stock-based compensation and personnel-related expenses. The company faces uncertainty regarding the final determination of nalbuphine's scheduling status, which will be made upon FDA and DEA approval. Trevi Therapeutics Inc (NASDAQ:TRVI) needs to conduct further studies and regulatory discussions to advance Haduvio's development, which may impact timelines and require additional resources. Q: Could you speak about the patients enrolled in the CORAL study and any differences observed in the first and second halves of the study? A: Jennifer Good, President and CEO, explained that no changes were made to the study as it was already 75-80% enrolled by December. The study statistics remained consistent, and no changes were communicated to the sites to ensure consistency in the study protocol. Q: Can you comment on the discontinuation rate in the CORAL study? A: Jennifer Good confirmed that the discontinuation rate remained in single digits throughout the study, indicating consistency and stability in the patient population. Q: What are your expectations for the placebo response in the IPF chronic cough Phase 2 study? A: Jennifer Good stated that placebo hasn't been a significant issue in IPF studies. The study assumed a 66% drug effect and a 30% placebo effect, with the SSRE confirming these assumptions. Placebo effects in prior IPF cough studies have ranged from 15% to 23%. Q: How do you see the RCC patient population being split between P2X3 and Haduvio if both are on the market? A: Jennifer Good mentioned that Haduvio would target patients who have failed prior therapies, potentially serving as a second or third-line treatment. The unmet need remains high, especially since P2X3 antagonists have shown efficacy primarily in severe coughers. Q: Regarding the RIVER RCC data, are there any plans to adjust dosing in future studies? A: Jennifer Good noted that the effective dose appears to be in the 27 to 54 mg range, and the 108 mg dose may not be necessary. This allows for more flexibility in dosing and potentially reduces adverse effects. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
07-03-2025
- Entertainment
- Yahoo
Mini Crossword: Crawley, Downton Abbey Countess & Other Hints for February 28
Are you ready to solve and find the answers to the for February 28, 2025, with the help of hints? This puzzle game is quite different from the traditional long crosswords. In mini crosswords, players work with a simple 5 x 5 grid and fill in words across and down. Additionally, there is in-game assistance available to help make the process smoother. Here are the hints and clues for the NYT Mini Crossword for February 28, 2025. These clues showcase intriguing themes like movies, shows, cartoon characters, celebrities, and daily-use items. Yesterday's puzzle featured hints related to messages to office staff, a calculator key, a renowned casino, so-so, a pronoun pair, and many others. ACROSS 1A Italian tourist city you might be 'inclined' to visit 5A Pink/orange shade 6A Green/yellow shade 7A Red/pink shade 8A Silver/gray shade DOWN 1D Many collared golf shirts 2D From Dublin or Derry 3D Command+S, on a Mac 4D Pint at a public house 5D _ Crawley, 'Downton Abbey' countess As the game has already concluded, let's uncover the answers for the NYT Mini Crossword from February 28, 2025. ACROSS 1A PISA 5A CORAL 6A OLIVE 7A ROSE 8A ASH DOWN 1D POLOS 2D IRIS 3D SAVE 4D ALE 5D CORA Today's game featured a captivating mix of clues, including references to an Italian tourist, various shades of color, collared gold shirts, and the Countess from Downton Abbey. The puzzle was relatively straightforward but still posed a challenge. For players who regularly engage with this puzzle game, today's edition may have felt easier due to the hints provided. This was all for today's NYT Mini Crosswords. Do come back again to check out a new puzzle with exciting clues. The post Mini Crossword: Crawley, Downton Abbey Countess & Other Hints for February 28 appeared first on - Movie Trailers, TV & Streaming News, and More.
