Initiated Phase 2 Clinical Trial for Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)
“The successful completion of our IPO enables Trevi to continue development of nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF), and levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease,” said
First Quarter 2019 Highlights and Recent Events
- Activated clinical sites in
Europefor the PRISM trial: During the first quarter of 2019 Trevi commenced activation of clinical sites in Europeand have begun enrolling patients in the PRISM trial in Europe.
- Initiated Phase 2 trial of nalbuphine ER for chronic cough in patients with IPF in
June 2019: The Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in up to 56 patients with IPF in the United Kingdom. The primary endpoint for the study is the mean change in daytime cough frequency as measured by a cough monitor. The study will also examine various secondary endpoints. Trevi plans to report top-line data from this trial in the first half of 2020.
- Completed initial public offering (IPO): In
May 2019, Trevi announced it had completed its IPO of 5,500,000 shares of common stock and a concurrent private placement of 1,500,000 shares of common stock, resulting in combined net proceeds to the Company of approximately $62.6 millionafter deducting underwriting discounts and commissions and estimated offering expenses. Shares outstanding immediately after the IPO and private placement were approximately 17.8 million.
- Licensed patents for use of nalbuphine ER for treatment of LID in Parkinson’s disease: In
February 2019, Trevi announced it had entered into exclusive license agreements with Rutgers, The State University of New Jerseyand MentiNova, Inc.for intellectual property and data supporting the development of nalbuphine ER for LID in patients with Parkinson’s disease. Based on feedback from the Food and Drug Administration( FDA) in a pre-IND meeting earlier this year, Trevi plans to submit an IND in preparation for a Phase 2 trial of nalbuphine ER in this indication expected to commence in the second half of 2019.
First Quarter 2019 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the first quarter of 2019 were
General and administrative (G&A) expenses: G&A expenses for the first quarter of 2019 were
Net loss: For the first quarter of 2019, Trevi reported a net loss of
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.
About Nalbuphine ER
Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-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
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, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the expected timing of the re-estimation analysis for, and for reporting top-line data from, Trevi’s Phase 2b/3 PRISM trial of nalbuphine ER in patients with prurigo nodularis; the expected timing of commencement of Trevi’s planned Phase 2 clinical trial of nalbuphine ER for treatment of LID in Parkinson’s disease; Trevi’s business plans and objectives, including future plans or expectations for Trevi’s product candidates and expectations regarding Trevi’s uses and sufficiency of capital; and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost, and timing of the Trevi’s product candidate development activities and planned clinical trials; uncertainties regarding Trevi’s ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in
Trevi Therapeutics, Inc.
Selected Balance Sheet Data
(amounts in thousands)
|Cash and cash equivalents||$||12,946||$||7,202|
Trevi Therapeutics, Inc.
Selected Statement of Operations Data
(amounts in thousands)
|Three Months Ended
|Research and development||$||3,338||$||2,363|
|General and administrative||1,474||779|
|Total operating expenses||4,812||3,142|
|Loss from operations||(4,812)||(3,142)|
|Other income (expense), net:||6||(934)|
|Loss before income tax benefit||(4,806)||(4,076)|
|Income tax benefit||4||25|