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Yahoo
02-06-2025
- 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
Yahoo
29-05-2025
- Business
- Yahoo
Trevi Therapeutics to Participate in Upcoming June Conferences
NEW HAVEN, Conn., May 29, 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), today announced that senior management will be participating in the following conferences in June. American Cough ConferenceJune 6 – 7, 2025, Dulles, VirginiaOral Presentation: June 6, 4:05 p.m. ETPresentation: Baseline demographics and characteristics from the RIVER trial evaluating nalbuphine extended-release tablets in patients with refractory chronic coughTrevi Representatives: Jennifer Good, President and CEO, James Cassella, Ph.D., CDO, Danine Summers, VP of Medical Affairs and Abbey Nakano, Pharm.D., AD of Medical AffairsRegister here CPDD 87th Annual Scientific MeetingJune 14 – 18, 2025, New Orleans, LouisianaPoster Presentation: June 18, 2:00 p.m. CTPoster: Assessment of Human Abuse Potential of Nalbuphine in Non-Dependent Recreational Drug UsersPoster Session: 4Trevi Representative: Thomas Sciascia, M.D., Co-Founder and CSORegister here BIO International ConventionJune 16 – 19, 2025, Boston, MassachusettsCorporate Presentation: June 17, 12:15 p.m. ETTrevi Representatives: Jennifer Good, President and CEO, and Farrell Simon, Pharm.D., CCORegister here About Trevi Therapeutics, 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 with IPF chronic cough patients and RCC patients. 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. Chronic cough is a highly prevalent condition in IPF patients, impacting up to 85% of the IPF population. There are ~150,000 U.S. IPF patients and 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. Refractory chronic cough has no approved therapies in the U.S. and is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) and includes unexplained chronic cough. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is a highly debilitating disease and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. 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. Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 carlsonj@ Media Contact Rosalia Scampoli 914-815-1465 rscampoli@ View original content to download multimedia: SOURCE Trevi Therapeutics, Inc. Sign in to access your portfolio
Yahoo
03-04-2025
- Health
- Yahoo
Trevi Therapeutics to Participate in Upcoming April Investor Conferences
NEW HAVEN, Conn., April 3, 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 refractory chronic cough (RCC), today announced that senior management will be participating in the following investor conferences in April. 24th Annual Needham Virtual Healthcare ConferenceApril 7-10, 2025Corporate Presentation: April 7, 11:00-11:40 a.m. ETTrevi Representatives: Jennifer Good, President and CEO, and Farrell Simon, CCORegister here to watch the live presentation. Jones Healthcare and Technology Innovation ConferenceApril 8-9, 2025, Las Vegas, NevadaCorporate Presentation: April 9, 11:00-11:20 a.m. PTTrevi Presenter: Jennifer Good, President and CEOPresentation available to in-person attendees. Piper Sandler Spring Biopharma SymposiumApril 16-17, 2025, Boston, MassachusettsTrevi Representatives: Jennifer Good, President and CEO, and James Cassella, CDO About Trevi Therapeutics, 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 refractory chronic cough (RCC). Haduvio is the first and only therapy in clinical development to show a statistically significant reduction in chronic cough across patients with both IPF and RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough is a highly prevalent condition in IPF patients, impacting up to 85% of the IPF population. There are ~140,000 U.S. IPF patients and 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. Refractory chronic cough has no approved therapies in the U.S. and is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) and includes unexplained chronic cough. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is a highly debilitating disease and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. 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. Investor ContactJonathan CarlsonTrevi Therapeutics, Inc.(203) 654 3286carlsonj@ Media ContactRosalia Scampoli914-815-1465rscampoli@ View original content to download multimedia: SOURCE Trevi Therapeutics, Inc. Sign in to access your portfolio
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.
