Trevi Therapeutics Maps Haduvio Chronic Cough Push, Sees Cash Runway Into 2030

Key Points

• Trevi Therapeutics is moving Haduvio into multiple chronic cough indications, starting with idiopathic pulmonary fibrosis (IPF) cough, and plans to begin its Phase 3 OCEAN program this quarter. The company also expects to advance programs in non-IPF ILD cough and refractory chronic cough (RCC), both of which it says remain largely untreated markets.
• The company’s clinical timeline calls for OCEAN 1 to start this quarter, OCEAN 2 in the third quarter, and data readouts in the second half of 2027 and first half of 2028. Its RCC study, LAKE, is also slated to begin this quarter, with a readout expected in the second half of 2027.
• Trevi said a recent $162 million financing extends its cash runway into 2030, enough to fund the lead IPF trials through NDA filing and potentially FDA approval. Management also outlined a specialty respiratory commercial strategy and said a U.S. launch could come in late 2029 if development stays on track.

Trevi Therapeutics NASDAQ: TRVI outlined plans to advance Haduvio, its extended-release formulation of nalbuphine, across multiple chronic cough indications, with management emphasizing upcoming clinical trial starts, a specialty commercial strategy and an extended cash runway following a recent financing.

At a company event, President and CEO Jennifer Good said Trevi is focused on building a leadership position in chronic cough, beginning with idiopathic pulmonary fibrosis, or IPF, cough. Good said the company believes nalbuphine ER has a “dual mechanism of action” targeting both central and peripheral components of the cough reflex arc.

Good said Trevi plans to initiate its Phase 3 IPF cough program this quarter and is also preparing development programs in non-IPF interstitial lung disease, or ILD, and refractory chronic cough, or RCC. She described the markets as large and underserved, with no approved therapies for the chronic cough indications Trevi is targeting.

Clinical Programs Moving Toward Multiple Readouts

Chief Development Officer James Cassella described Trevi’s IPF cough program, named OCEAN, as consisting of two Phase 3 trials. OCEAN 1 is expected to include a two-week titration period followed by 52 weeks of fixed-dose treatment and a three-week safety follow-up. OCEAN 2 is expected to include a 12-week fixed-dose period, also followed by safety follow-up.

Cassella said OCEAN 1 is expected to begin this quarter, with OCEAN 2 to follow in the third quarter. He said data readouts are expected in the second half of 2027 and the first half of 2028. The primary efficacy endpoint in both studies will be 24-hour objective cough count.

Trevi’s RCC program, named LAKE, is also expected to begin this quarter. Cassella said the study will evaluate placebo and three active dose regimens: 27 milligrams once daily, 27 milligrams twice daily and 54 milligrams twice daily. The trial is expected to include a sample size re-estimation, with a readout in the second half of 2027.

For non-IPF ILD cough, Cassella said Trevi plans an adaptive Phase 2b/3 program and expects to discuss the design with the FDA in the third quarter. He said the company is considering an sNDA approach that would follow a potential IPF approval.

Experts Highlight Burden of Cough in IPF, ILD and RCC

Toby Maher, professor of clinical medicine and director of interstitial lung disease at the Keck School of Medicine of USC, said cough is a major quality-of-life burden for patients with IPF and other ILDs. He said current antifibrotic therapies may slow disease progression but do not meaningfully improve symptoms such as cough.

Maher said patients with pulmonary fibrosis often reduce travel, restaurant visits and other social activities because of coughing. He also said cough occurs with similar frequency across different forms of ILD and that the mechanisms driving cough are “virtually identical” across these diseases.

Peter Dicpinigaitis, professor of medicine at Albert Einstein College of Medicine, said RCC is often underappreciated and can be “life-destroying” for patients. He said chronic cough is defined as cough lasting more than eight weeks, while RCC refers to chronic cough that has not responded to appropriate treatment for common causes such as upper airway cough syndrome, eosinophilic airway disease and reflux.

Dicpinigaitis said there are currently no FDA-approved drugs for chronic cough in the United States. He cited off-label use of neuromodulators such as amitriptyline and gabapentin, but said his experience with those options has been limited by tolerability and efficacy.

Commercial Strategy Focuses on Specialty Respiratory Launch

Chief Commercial Officer Farrell Simon said Trevi is pursuing a specialty commercial model centered on pulmonologists, with a potential sales force of 50 to 75 representatives. He said the company expects IPF and non-IPF ILD to be addressed through the same infrastructure because patients are treated by many of the same specialists and care centers.

Simon said Trevi estimates total addressable markets of $5 billion to $12 billion for IPF cough, $7 billion to $15 billion for non-IPF ILD cough and more than $20 billion for treatment-resistant RCC. He said the company believes Haduvio could become a $6 billion peak sales franchise across the three indications, based on internal market assumptions.

Simon said physician and payer research conducted by Trevi showed recognition of high unmet need in IPF and ILD cough. He said Trevi tested annual pricing ranges of $75,000 to $125,000 with payers for IPF and did not see significant differences across that range, though he said payers would likely use utilization management such as prior authorization and step-through requirements.

Financing Extends Runway Into 2030

Chief Financial Officer David Hastings said Trevi raised $162 million in net proceeds through an April follow-on offering. Combined with the $72 million the company reported as of March 31, Hastings said the financing extends Trevi’s cash runway into 2030.

Hastings said the runway is expected to fund the two IPF Phase 3 studies through NDA filing and potentially FDA approval in the lead indication, as well as the Phase 2b and potentially Phase 3 work in non-IPF ILD and Phase 2b data in RCC. He said the proceeds do not fund commercial expenses or other clinical trials.

Good also said Trevi is investing in intellectual property protection around Haduvio, including method-of-treatment patents and potential claims tied to dosing, titration and formulation. She said the company is working to build beyond a patent estate it believes protects the IPF cough opportunity through 2039.

Good said Trevi’s current plan could lead to an FDA submission roughly six months after the OCEAN 1 readout, with a potential launch in late 2029 if development and regulatory timelines proceed as expected.

About Trevi Therapeutics NASDAQ: TRVI

Trevi Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel non-opioid therapies for the management of chronic and acute pain. The company leverages proprietary drug delivery platforms and targeted molecular approaches to address high unmet needs in cancer-related pain, chemotherapy-induced neuropathy and other severe pain conditions.

Its lead product candidate is a proprietary formulation of tetrodotoxin (TTX), a sodium-channel blocking agent being evaluated in early-stage clinical trials for moderate-to-severe pain associated with advanced cancer and peripheral neuropathy.

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