subslover
2年前
Trevi Therapeutics Announces Positive Outcome from Sample Size Re-estimation Resulting in No Change to the Current Sample Size for the Phase 2b CORAL Trial in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough
Independent Data Monitoring Statistician reaffirmed current sample size to remain at N=160
The trial has reached 75% of the targeted enrollment, and topline results continue to be expected in the first half of 2025
NEW HAVEN, Conn., Dec. 12, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced the positive outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in IPF patients with chronic cough, which requires no change to the current sample size for the trial (N=160). The trial has reached 75% of the targeted enrollment, and topline results from the full trial continue to be expected in the first half of 2025.
The SSRE analysis was conducted on the highest dose (108mg twice daily) in the trial after 50% of the initial targeted trial enrollment, or 80 patients, completed the six weeks of treatment. Based on the SSRE analysis, it was recommended that the CORAL trial should continue as planned to maintain the pre-specified conditional power of 80% or greater. The other two potential pre-specified outcomes of the SSRE analysis were an increase in the sample size or futility.
"We are pleased that the SSRE outcome supports the continued execution of the CORAL trial with the total number of patients as originally planned," said Jennifer Good, President and CEO of Trevi Therapeutics. "This positive SSRE outcome is reassuring and confirms the key powering assumptions of the trial design. We believe this is additional confirmation of the strong efficacy observed in the Phase 2a CANAL trial in IPF cough and is an important milestone reaffirming our belief in Haduvio's best-in-class and first-in-class potential for patients with IPF chronic cough where there are no approved therapies."
Phase 2b IPF Chronic Cough Trial Design (CORAL):
The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) compared to placebo in IPF patients with chronic cough. Approximately 160 IPF patients with chronic cough will be randomized 1:1:1:1 to one of three Haduvio doses or placebo for a period of 6 weeks. This includes an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at the end of Week 6 versus baseline for Haduvio compared to placebo, as measured with an objective cough monitor (VitaloJAK®). The trial will also explore secondary endpoints, including patient reported outcome measures for cough.
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 refractory chronic cough (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 disease 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 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 IPF and current off-label treatment options provide minimal benefit to patients.
Refractory chronic cough affects approximately 2-3 million adults in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is highly disruptive 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. Haduvio is being developed for the treatment of moderate to severe RCC. There are also no approved therapies for RCC in the U.S.
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 www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
subslover
4年前
Trevi Therapeutics Reports Positive Results from the Ph2b/3 PRISM Trial of Haduvio™ in the Treatment of Prurigo Nodularis
Haduvio (oral nalbuphine ER) demonstrated statistically significant results on the primary efficacy endpoint as measured by a 4-point reduction in the Worst Itch – Numerical Rating Scale (WI-NRS) (p=0.0157)
The trial also met key secondary endpoints, with a safety profile consistent with prior studies
Topline data will be presented by management and study investigator, Jennifer L Parish, MD, on a conference call and webcast on June 29, 2022, at 8:30 am EDT
NEW HAVEN, Conn., June 29, 2022 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ (oral nalbuphine ER) for prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis (IPF), today announced positive results from its Phase 2b/3 Pruritus Relief through Itch-Scratch Modulation (PRISM) trial of Haduvio in treating prurigo nodularis.
Trevi Therapeutics Ph2b/3 PRISM trial of Haduvio achieves statistical significance for the treatment of Prurigo Nodularis
"We are very pleased to announce the statistically significant results for Haduvio from the PRISM trial, the first and only oral therapy to demonstrate in a clinical trial a positive result in treating prurigo nodularis," said Jennifer Good, President and CEO of Trevi Therapeutics. "This positive trial in prurigo nodularis, along with the highly statistically significant data from the interim analysis of our Phase 2 trial in IPF chronic cough that we presented earlier this year, further supports our belief that Haduvio could potentially benefit patients across a broad range of refractory chronic pruritic and cough conditions."
Prurigo nodularis is a chronic disease characterized by severe pruritus and the presence of nodules, lesions, and excoriations. Chronic pruritus is a key contributing cause of prurigo nodularis and manifests in an itch-scratch cycle, which is difficult to disrupt. There are no approved therapies for prurigo nodularis where a large unmet need exists due to its impact on patients' quality of life, function, and emotional well-being.
"Prurigo nodularis is one of the most challenging dermatologic diseases for clinicians to manage," said Jennifer L Parish, MD, Dermatologist at Parish Dermatology and study investigator for the PRISM trial. "Patients suffer not only from the itching and the resulting excoriations, but many also suffer from anxiety often caused by the lack of effective treatments. It is exciting to see therapeutic options in development for this potentially devastating condition."
In the Phase 2b/3 PRISM trial, results comparing subjects randomized to Haduvio monotherapy (n=168) or placebo (n=176) showed:
25% of Haduvio subjects evaluated at week 14 met the primary endpoint of a 4-point reduction in WI-NRS from baseline compared to 14% of placebo subjects (p=0.0157).
Haduvio subjects experienced significantly greater improvements in ItchyQoL vs. placebo (p=0.0002) at week 14, which was statistically significant across each of the three domains (symptoms, functional limitations, and emotions). ItchyQoL is used to measure how pruritus impacts a subject's quality-of-life.
55% of Haduvio subjects saw at least a 1-category improvement in the 5-point scale in their Prurigo Activity Scale (PAS) (pruriginous lesions with excoriations), vs. 38% on placebo (p=0.006) as evaluated at week 14.
"In this study, Haduvio demonstrated an early onset of effect to reduce itch, which we believe improved quality of life for the patient as well as the underlying skin healing," said Dr. Bill Forbes, Chief Development Officer at Trevi Therapeutics. "We believe the ability of Haduvio to work both centrally and peripherally helps to break the ingrained itch-scratch cycle, which leads to the difficulty in treating prurigo nodularis. We look forward to analyzing these data further, along with the open label extension data, to help inform continued development in this area of high unmet need."
The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials. During the double-blind titration period (weeks 1-2) Treatment-Emergent Adverse Events (TEAE) were more common in the Haduvio-treated subjects (66.1%) vs. placebo-treated subjects (31.3%). During the 12-week fixed-dose period, the occurrence of TEAEs were generally similar between Haduvio and placebo groups (48% Haduvio, 45% placebo). Discontinuations during the 14 weeks of the trial were 36.9% in Haduvio-treated subjects vs. 19.3% in placebo-treated subjects. During the 14-week double-blind portion of the PRISM trial, 8 subjects on Haduvio and 6 subjects on placebo experienced at least one treatment emergent Serious Adverse Event (SAE). None of the SAEs were considered by the investigator to be treatment-related. Adverse events most commonly observed with Haduvio were nausea, dizziness, headache, and constipation.
Conference Call Details
To participate in the live conference call by phone, please dial (888) 317 6003 (domestic) or (412) 317 6061 (international) and provide access code 8601030. A live audio webcast and presentation will be accessible from the 'Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast and the presentation will also be available for 60 days on the Company's website following the event.
About PRISM
The Phase 2b/3 Pruritus Relief through Itch Scratch-Modulation (PRISM) trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Haduvio in prurigo nodularis. In the trial, subjects are randomized equally across two treatment groups (oral Haduvio 162 mg or placebo, twice daily including an initial 2-week blinded titration period). The primary endpoint of the trial is the proportion of subjects achieving a greater than or equal to 4-point improvement in the weekly mean Worst Itch Numerical Rating Scale (WI-NRS) score at Week 14 compared to baseline. Subjects that complete week 14 are eligible to roll into an additional 38-week open label extension trial. More information about the PRISM trial is available at www.clinicaltrials.gov: NCT03497975
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio for the treatment of prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.
About Haduvio
Haduvio, an investigational therapy, is an oral extended-release (ER) formulation of nalbuphine. Nalbuphine is a mixed ?-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ?- and µ-opioid receptors are kno
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