Trevi Therapeutics Shares Progress on Chronic Cough Trials

Trevi Therapeutics Updates on Clinical Trials

Trevi Therapeutics, Inc. (NASDAQ: TRVI), a clinical-stage biopharmaceutical company, is making strides in its clinical trials aimed at treating chronic cough related to idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). This progress comes as the company prepares to participate in the 14th Annual LifeSci Partners Corporate Access Event, coinciding with the J.P. Morgan Healthcare Conference. Recently, the final patient completed their visit in the Phase 2a RIVER trial for RCC, with dense expectations for topline results to be released shortly.

Highlights from the RIVER and CORAL Trials

The RIVER trial focused on treating RCC and prompts optimism since the trial was anticipated to involve around 60 patients. Following the last patient visit early this month, the topline results are now expected in the first quarter of the upcoming year. Furthermore, significant progress has been reported in the Phase 2b CORAL trial targeting chronic cough in IPF patients. Currently, about 80% of the enrollment is concluded, and the company remains on track for topline results to emerge in the first half of the next year.

Positive Developments and Milestones

Jennifer Good, President and CEO of Trevi Therapeutics, shared enthusiasm regarding the anticipated readouts from both the RCC and IPF trials. Trevi's robust performance in clinical operations throughout the preceding year has laid a solid groundwork for achieving meaningful milestones. Particularly notable was the positive outcome from the sample size re-estimation analysis of the CORAL trial, which confirmed the existing sample size, allowing for a more definitive approach to data interpretation.

Strong Financial Position

As of the end of the last year, Trevi's financial health appears promising, with estimates of cash, cash equivalents, and marketable securities reaching $107.6 million. This solid financial footing is poised to sustain the company through its ongoing trials and into the second half of 2026, enabling it to remain focused on developing therapies that target chronic cough conditions.

Understanding Chronic Cough in IPF Patients

Chronic cough is a prevalent issue for patients suffering from IPF, with some studies estimating that it affects up to 85% of this population. Typically, IPF patients experience debilitating cough episodes that can occur up to 1,500 times daily, significantly impairing their quality of life. The desire for effective treatments is critical, as existing options provide minimal relief. The absence of approved therapies further heightens the urgency for innovations like Haduvio™.

Innovation in Therapy Development

Haduvio™, an investigational drug developed by Trevi, aims to address chronic cough through a unique mechanism of action. As a kappa agonist and mu antagonist, this therapy targets both central and peripheral pathways of the cough reflex, indicating a multifaceted approach to relief. As of now, no equivalent approved therapies exist for chronic cough in IPF or RCC patients, underlining the potential impact of Haduvio™ if proven effective.

Future Outlook for Trevi Therapeutics

Looking ahead, Trevi Therapeutics is committed to showcasing Haduvio as the preferred name for oral nalbuphine extended-release. Notably, Trevi's ongoing efforts and commitment to clinical excellence propose a path forward for patients enduring chronic cough, who currently find their options limited. The attention at forthcoming conferences, along with a strategic focus on trial outcomes, marks an optimistic trajectory for Trevi and its objectives.

Frequently Asked Questions

What is Trevi Therapeutics focused on?

Trevi Therapeutics is focused on developing novel therapies for patients suffering from chronic cough, particularly in the context of idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).

What are the key trials Trevi Therapeutics is conducting?

The key trials include the Phase 2a RIVER trial for refractory chronic cough and the Phase 2b CORAL trial for chronic cough in patients with IPF.

What is Haduvio and how does it work?

Haduvio is an investigational therapy under development for chronic cough, functioning as a kappa agonist and mu antagonist, targeting cough reflex pathways.

What financial standing does Trevi Therapeutics have?

As of the end of the last year, Trevi holds approximately $107.6 million in cash, cash equivalents, and marketable securities, ensuring a promising cash runway for upcoming clinical activities.

Why is chronic cough a critical area of focus?

Chronic cough significantly impacts the quality of life for affected patients, with no approved therapies currently available specifically targeting this condition, intensifying the need for effective treatments.

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