Trevi Therapeutics (TRVI)

[Monksdream]

Already banked
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[subslover]

Trevi Therapeutics Announces Positive Topline Results from the Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough
Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline

Haduvio showed similar efficacy in patients with moderate or severe cough counts (p<0.0001)

Haduvio is the first and only therapy to show a statistically-significant reduction in chronic cough across both RCC and IPF patients

Patient reported and other secondary outcomes were statistically significant and consistent with the primary endpoint

Company to host a conference call and webcast today at 8:30 a.m. ET and will be joined by key opinion leader, Professor Jacky Smith

NEW HAVEN, Conn., March 10, 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), is pleased to announce today positive topline results from its Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66). Haduvio met the primary endpoint with a statistically-significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p<0.0001).


"I am happy to share these robust positive results from our Phase 2a RIVER trial in refractory chronic cough which has been a difficult-to-treat indication with no approved therapies in the U.S.," said Jennifer Good, President and Chief Executive Officer of Trevi Therapeutics. "The RIVER trial demonstrated that Haduvio was highly effective, and worked quickly at the lowest dose tested across a broad range of cough counts. These results, coupled with our existing IPF chronic cough results, are further evidence of the effectiveness of Haduvio's central and peripheral KAMA mechanism in treating these difficult neurological cough conditions which are so disruptive to patients' lives."

James Cassella, Ph.D., Chief Development Officer of Trevi Therapeutics added, "The results from the RIVER trial were highly statistically significant with consistent outcomes across the primary and analyzed secondary endpoints as well as for patients with moderate or severe baseline cough frequency. We look forward to advancing development of nalbuphine ER in the hopes of providing relief for the significant unmet need for these chronic cough patients. Based on these results, we plan to discuss next steps with the FDA and anticipate initiating the next study after we receive their input. Thank you to all the patients and investigators who contributed to our trials and continue to advance clinical research to find a treatment for chronic cough."

"I am excited to see the positive results from the Phase 2a RIVER trial and the potential role nalbuphine ER could have in therapy for RCC patients," said Professor Jacky Smith, Professor of Respiratory Medicine at the University of Manchester. "RCC significantly impacts patients' lives both physically and psychologically, resulting in chest pain, urinary incontinence, depression, exhaustion, dizziness and much more. Therapies are desperately needed as patients continue to suffer from this debilitating disease."

The Phase 2a Refractory Chronic Cough Improvement Via Nalbuphine ER (RIVER) trial was a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety and tolerability of Haduvio for the treatment of patients with RCC. Each treatment period lasted 21 days, separated by a 21-day washout period. During the Haduvio treatment period, patients were titrated with assessments at 27 mg twice daily (BID), 54 mg BID and 108 mg BID, with objective cough and other assessments at each dose. The primary endpoint of the trial was the mean change in 24-hour cough frequency, as determined by an objective cough monitor, for the full analysis set (FAS) population at Day 21. The FAS population included all patients who received at least one dose of study drug and have objective cough count data on both Baseline and Day 21 in at least one treatment period.

Primary Endpoint


Change from Baseline in 24-hour Cough Frequency at Day 21

Haduvio 108 mg BID

-67 %

Placebo BID

-10 %

Difference from placebo

57% (p<0.0001)

Additional Endpoints

Haduvio demonstrated a statistically-significant reduction in 24-hour cough frequency of 66% in the severe cough (20+ coughs/hour) subgroup (p<0.0001) and 68% in the moderate cough (10-19 coughs/hour) subgroup (p<0.0001).
84% of Haduvio patients had at least a 30% reduction in 24-hour cough frequency vs. baseline, as compared to 29% of placebo patients, a difference of 55% (p<0.0001).
A statistically-significant reduction in 24-hour cough frequency, as measured by an objective cough monitor, was seen as early as Day 7 (27 mg BID) for patients on Haduvio (p<0.0001).
Patients on Haduvio experienced a statistically-significant improvement in patient reported outcomes compared to placebo as early as Day 7 (27 mg BID) in the Cough Severity Visual Analog Scale and the Patient-Reported Cough Frequency.
The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials. The most common adverse events experienced included: constipation, nausea, somnolence, headache, dizziness, and fatigue and there were no treatment emergent serious adverse events.
Conference Call
The Company will host a conference call and webcast to review the topline results today, March 10th, 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 conference call by phone, please dial [phone] (domestic) or [phone] (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 Refractory Chronic Cough (RCC)
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.

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 highly prevalent 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.

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
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

[Monksdream]

TRVI , under $5

[glenn1919]

trvi........................https://stockcharts.com/h-sc/ui?s=trvi&p=W&b=5&g=0&id=p86431144783

[subslover]

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

[glenn1919]

trvi..............................
https://stockcharts.com/h-sc/ui?s=trvi&p=W&b=5&g=0&id=p86431144783




.lostintheshuffle.....................................4

[tw0122]

Cough it's way back above $4 +60% 40m
Floater 

[Monksdream]

TRVI under $4

[Monksdream]

TRVI under $3

[Monksdream]

TRVI under $3

[TrendTrade2016]

TRVI...BREAK OUT BIO BEAST

[Monksdream]

TRVI new 52 week low

[glenn1919]

TRVI....................................https://stockcharts.com/h-sc/ui?s=TRVI&p=W&b=5&g=0&id=p86431144783

[starkd748]

I want 2.75s

[starkd748]

Come on keep moving

[starkd748]

Held after gap fill...Glad I loaded Fri

[starkd748]

https://www.tradingview.com/x/TC0syZyI/

Yup no reversal after gap fill then it's toast falling more like a 1,000lb hemorrhoid...Covered my short thanks pumpers on stock wits

[starkd748]

Gap fill time making lower lows...I'll wait

[subslover]

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 [phone] (domestic) or [phone] (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

[7zienza7]

Thanks

[TrendTrade2016]

private placement pops are different then offerings, offerings always come at top...all out....3.13 resistance.

[7zienza7]

I'm a bit confused...the news was about dilution, right? And yet the price shot up. Can you explain?

[wile.e.coyote]

EOD near HOD ... news today .... $10 PT .... we'll see what happens tomorrow ....

[TrendTrade2016]

TRVI ready to rock!!!!!!

[TrendTrade2016]

TRVI low floater taking off!!

[$oldier Hard]

Seriously overbought, all out at $1.73

[$oldier Hard]

$TRVI, this works!

[$oldier Hard]

$TRVI 5 times it's avg 10 day volume, so far today.

[$oldier Hard]

You still here with me?

[$oldier Hard]

I agree.

[ttottip]

Very interesting here.

[frugalNorwegian]

Brand new Reddit forum discussion TRVI.

https://www.reddit.com/r/TRVI_Stock/

[Long_Holder]

TRVI
Updated information from the most recent corporate presentation.
I love this stock, been accumulating for about a year.

Prurigo Nodularis – PRISM Trial Update (main indication)
• Approximately 155 subjects enrolled as of 8/13/2020
• COVID-19 screening restrictions lifted in May/June for sites and had
strong enrollment since
• Positive sample size re-estimation read-out this summer. Trial moving
forward with an increase in the sample size to maintain the power
(n=360)
• We have opened more than 60 sites in the US and Europe
• Guidance: Complete Enrollment - Q3 2021
Top-line Data - Q4 2021
• More than 95% of subjects have continued into the one-year open label
extension study

This is a small float, under valued ticker, with Cash position to fund operations into the first half of 2022.

Float 12.0M Shares
Outstanding 18.2M
Institutions Holding Shares 16
% Held by Institutions 79.72%

[BioSpecialist]

UPPPP 13%+

[BioSpecialist]

RALLYYYYYYYYYYYYYYYYYYYYYYyyy

[BioSpecialist]

Up 7%+ on no volume so once we get good news here this extreme low float gem will go through the roof

[BioSpecialist]

Major breakout to $5+ could start anytime now

[BioSpecialist]

One of the cheapest biotech you can get at this time .STRONG BUY