NEW HAVEN, Conn. - Trevi Therapeutics, Inc. (NASDAQ: NASDAQ:TRVI), a clinical-stage biopharmaceutical company with a market capitalization of $214 million, announced today that its investigational therapy Haduvio (oral nalbuphine ER) has shown positive results in a human abuse potential (HAP) study. According to InvestingPro data, the company's stock has delivered an impressive return of ~113% year-to-date, reflecting growing investor confidence in its development pipeline. The study found statistically significant lower "Drug Liking" for the 81mg and 162mg doses of oral nalbuphine compared to intravenous (IV) butorphanol, covering the clinical dose range for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
The randomized, double-blind, placebo-controlled study evaluated the abuse potential of oral nalbuphine in recreational drug users. The primary endpoint measured the peak effect of "Drug Liking" on a 100-point visual analog scale. The 81mg and 162mg doses of oral nalbuphine demonstrated a significantly lower mean Emax for "Drug Liking" (71.2 and 74.5, respectively) when compared to 6mg IV butorphanol (82.3), with p-values of less than 0.0001 and 0.0008, respectively.
Secondary endpoints of the study included pharmacodynamic markers and patient reported outcomes, which generally aligned with the primary endpoint. No serious adverse events were reported, indicating a favorable safety profile. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 7.38, while holding more cash than debt on its balance sheet. Get access to 8 more key ProTips and comprehensive financial analysis with an InvestingPro subscription.
James Cassella, Ph.D., Chief Development Officer of Trevi Therapeutics, expressed satisfaction with the study results, highlighting the validity of the study design and its consistency with nalbuphine's known profile. Jack Henningfield, Ph.D., Vice President at Pinney Associates, emphasized nalbuphine's long-standing unscheduled status in the U.S. and its potential to address health needs without the public safety risks associated with opioids.
The results will contribute to the 8-factor analysis of nalbuphine's abuse potential to be included in a future new drug application (NDA) submission for regulatory review.
Trevi Therapeutics is developing Haduvio to address the unmet medical needs of patients with chronic cough associated with IPF and RCC, conditions affecting millions in the U.S. The company will host a conference call and webcast today at 5:00 p.m. ET to discuss these topline results.
This news article is based on a press release statement from Trevi Therapeutics, Inc. With analyst price targets ranging from $6 to $21, significantly above the current trading price of $2.78, investors seeking detailed insights can access the complete Pro Research Report, available exclusively on InvestingPro, which provides comprehensive analysis of the company's financial health, growth prospects, and market position.
In other recent news, Trevi Therapeutics reported its Q3 2024 financial results, including a net loss of $13.2 million, an increase from the previous year's $7.7 million. The company's research and development expenses were elevated due to ongoing clinical trials for its drug Haduvio. The cash and equivalents held by Trevi stand at $65.5 million, projected to last into the second half of 2026.
Trevi is currently conducting several clinical trials, including the CORAL Phase 2b trial for chronic cough associated with idiopathic pulmonary fibrosis (IPF) and the RIVER trial for refractory chronic cough (RCC). Results from these trials are expected by the first half of 2025. Additionally, the results of the Human Abuse Potential study for injectable nalbuphine are anticipated in December 2024.
Despite an increased net loss and a decrease in cash and equivalents from $83 million at the end of 2023 to $65.5 million, Trevi is making steady progress in its clinical trials. The company is optimistic about significant data readouts in the near future and has enough funds to support operations well into 2026. These are some of the recent developments within Trevi Therapeutics.
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