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Hearth chat can be held on Tuesday, April 12, 2022, from 8:00 a.m. to eight:40 a.m. EDT
NEW HAVEN, Conn., April 5, 2022 /PRNewswire/ — Trevi Therapeutics, Inc. (Nasdaq: TRVI) is a clinical-stage biopharmaceutical firm growing an investigational oral remedy Haduvio™ (nalbuphine ER) for pruritus in prurigo nodularis (PN) and power cough in idiopathic pulmonary fibrosis (IPF). In the present day, Trevi introduced that Jennifer Good, President and Chief Govt Officer, together with Dr. Invoice Forbes, Chief Growth Officer, will take part in a hearth chat on the 21st Annual Needham Digital Healthcare Convention on Tuesday, April 12, 2022, at 8:00 a.m. ET.
A stay webcast of the fireplace chat can be accessible from the ‘Traders & Information’ part on the Firm’s web site at www.TreviTherapeutics.com. An archived replay of the webcast can even be accessible for 30 days on the Firm’s web site following the occasion.
About CANAL
Interim evaluation outcomes from the Part 2 Cough And NALbuphine (CANAL) trial had been statistically important on the first efficacy endpoint with a 77% discount in daytime cough frequency from examine baseline for Haduvio, demonstrating a 52% placebo-adjusted discount within the geometric imply p.c change (p<0.0001) (N=26). The secondary endpoints supported the profit seen within the main endpoint. Primarily based on the power and consistency of the efficacy knowledge, Trevi stopped recruitment and expects top-line knowledge for the complete set of topics within the third quarter of 2022. This interim evaluation was particularly to evaluate efficacy. There have been no reported deaths within the CANAL trial and 1 reported Critical Opposed Occasion (pneumonia) which was not thought-about remedy associated. The CANAL trial is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and security examine of nalbuphine ER for power cough in sufferers with IPF happening within the United Kingdom. The examine consists of two remedy durations of three weeks, with a washout interval of two weeks after every remedy interval. The first efficacy endpoint is to judge the impact of nalbuphine ER tablets on the imply daytime cough frequency at day 22 in comparison with placebo as measured by an goal cough monitor. Extra details about the CANAL trial is on the market at www.clinicaltrials.gov: NCT04030026
About PRISM
The Part 2b/3 Pruritus Aid by means of Itch Scratch Modulation (PRISM) trial is a randomized, double-blind, placebo-controlled examine to judge the efficacy and security of Haduvio for extreme pruritus in sufferers with PN. Within the trial, topics are randomized equally throughout two remedy teams (oral Haduvio 162 mg or placebo, twice each day together with an preliminary 2-week blinded titration interval). The first endpoint of the trial is the proportion of topics attaining a better than or equal to 4-point enchancment within the weekly imply Worst Itch Numerical Ranking Scale (WI-NRS) rating at Week 14 in comparison with baseline. The deliberate enrollment for the trial was roughly 360 topics. Prime-line knowledge is anticipated within the second quarter of 2022. Extra details about the PRISM trial is on the market at www.clinicaltrials.gov: NCT03497975
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical firm centered on the event and commercialization of the investigational remedy Haduvio to deal with critical neurologically mediated circumstances. Trevi is conducting a Part 2b/3 scientific trial of Haduvio for the remedy of power pruritus related to prurigo nodularis (PN) and a Part 2 trial for power cough in sufferers with idiopathic pulmonary fibrosis (IPF). These circumstances share a standard pathophysiology that’s mediated by means of opioid receptors within the central and peripheral nervous techniques.
Based in 2011, Trevi Therapeutics is headquartered in New Haven, CT.
About Haduvio
Haduvio, an investigational remedy, is an oral extended-release (ER) formulation of nalbuphine. Nalbuphine is a combined ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been accredited and marketed as an injectable for ache indications for greater than 20 years in the US and Europe. The ĸ- and µ-opioid receptors are recognized to be essential mediators of itch, cough and sure motion problems. Nalbuphine’s mechanism of motion can also mitigate the chance of abuse related to µ-opioid agonists as a result of it antagonizes, or blocks, µ-opioid receptors. Parenteral nalbuphine isn’t presently labeled as a managed substance by the DEA in the US or by regulatory authorities in most of Europe. Trevi intends to suggest Haduvio because the commerce title for nalbuphine ER. Nalbuphine ER (Haduvio) is an investigational remedy that has been granted Quick Observe designation by the FDA for the proposed indication of discount of average to extreme pruritus in sufferers with prurigo nodularis. Its security and efficacy haven’t been evaluated by any regulatory authority.
Ahead-Trying Statements
Statements contained on this press launch concerning issues that aren’t historic information are “forward-looking statements” throughout the that means of the Non-public Securities Litigation Reform Act of 1995. Such statements are topic to dangers and uncertainties and precise outcomes could differ materially from these expressed or implied by such forward-looking statements. Such statements embody, however should not restricted to, statements concerning the anticipated timing of reporting top-line knowledge from Trevi’s Part 2b/3 PRISM trial of Haduvio in topics with PN and the anticipated timing of reporting top-line knowledge from the complete set of topics’ knowledge from Trevi’s Part 2 CANAL trial of Haduvio in IPF topics with power cough; Trevi’s enterprise plans and goals, together with future plans or expectations for Trevi’s product candidates; expectations concerning Trevi’s makes use of and sufficiency of capital; and different statements containing the phrases “believes,” “anticipates,” “plans,” “expects,” and comparable expressions. Dangers that contribute to the unsure nature of the forward-looking statements embody: uncertainties concerning the success, value and timing of Trevi’s product candidate growth actions and ongoing and deliberate scientific trials, together with with respect to the timing of reporting top-line knowledge from each Trevi’s Part 2b/3 PRISM trial and Part 2 CANAL trial; uncertainties concerning Trevi’s means to execute on its technique; the chance that optimistic interim or top-line outcomes from a scientific trial could not essentially be predictive of the outcomes of the finished trial or different future or ongoing scientific trials; potential regulatory developments in the US and overseas international locations; uncertainties concerning quick monitor designation and the impact such standing might have on the regulatory evaluate or approval course of; uncertainties inherent in estimating Trevi’s money runway, future bills and different monetary outcomes, together with Trevi’s means to proceed as a going concern, adjust to its obligations below its mortgage facility and fund future operations; ; uncertainties concerning the scope, timing and severity of the COVID-19 pandemic, the affect of the COVID-19 pandemic on Trevi’s scientific operations and actions taken in response to the pandemic; in addition to different dangers and uncertainties set forth within the annual report on Type 10-Okay for the 12 months ended December 31, 2021 filed with the Securities and Change Fee and in subsequent filings with the Securities and Change Fee. All forward-looking statements contained on this press launch converse solely as of the date on which they had been made. Trevi undertakes no obligation to replace such statements to replicate occasions that happen or circumstances that exist after the date on which they had been made.
Investor Contact
Katie McManus
Trevi Therapeutics, Inc.
203-304-2499
[email protected]
Media Contact
Rosalia Scampoli
914-815-1465
[email protected]
SOURCE Trevi Therapeutics, Inc.
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