NEW HAVEN, CT – Trevi Therapeutics, Inc. (NASDAQ:TRVI), whose shares have surged over 110% year-to-date according to InvestingPro data, announced today positive outcomes from its human abuse potential (HAP) study for oral nalbuphine.
The study, which is part of the development process for the company's drug candidate, is a crucial step in assessing the abuse risk of new pharmaceuticals.
While the company maintains a strong liquidity position with a current ratio of 7.38, analysts have set ambitious price targets ranging from $6 to $21.
The randomized, double-blind, and controlled study evaluated the "Drug Liking" of oral nalbuphine in recreational drug users. The main goal was to compare the drug's likability to an active comparator and placebo. Oral nalbuphine demonstrated a statistically significant lower "Drug Liking" at clinical doses when compared to intravenous butorphanol, an active comparator.
The study's secondary endpoints, which included pharmacodynamic markers and patient-reported outcomes, supported the primary findings. Importantly, no serious adverse events were reported during the trial. These results are expected to be included in the 8-factor analysis for nalbuphine ER to inform scheduling considerations in any future new drug application submissions.
This announcement comes as the company continues to focus on the development of Haduvio, its extended-release formulation of nalbuphine. While Trevi Therapeutics provided forward-looking statements about its expectations for Haduvio and its development timeline, the company also acknowledged the inherent uncertainties in clinical trial outcomes and regulatory approval processes.
The positive findings from the HAP study mark a significant milestone for Trevi Therapeutics as it advances its clinical program. The company's shares are traded on The Nasdaq Stock Market LLC under the ticker symbol TRVI. The information in this article is based on a press release statement filed with the Securities and Exchange Commission.
In other recent news, Trevi Therapeutics has released its Q3 2024 financial results, revealing an increased net loss of $13.2 million, up from the previous year's $7.7 million. This increase is primarily due to the elevated research and development expenses for their ongoing clinical trials for the drug Haduvio. Despite this, the company's cash and equivalents stand at $65.5 million, projected to last into the second half of 2026.
Furthermore, Trevi announced positive results from a human abuse potential study for Haduvio, showing statistically significant lower "Drug Liking" for the 81mg and 162mg doses of oral nalbuphine. This information is expected to contribute to a future new drug application submission for regulatory review.
Simultaneously, Trevi is conducting several clinical trials, including the CORAL Phase 2b trial for chronic cough associated with idiopathic pulmonary fibrosis, and the RIVER trial for refractory chronic cough. Results from these trials are anticipated by the first half of 2025.
These are some of the recent developments within Trevi Therapeutics, as the company continues to progress in its clinical trials and maintains a stable financial position.
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