Sample Size Re-Estimation Analysis for PRISM Trial Expected in Mid-2020
New Patient Screening Re-Starting at PRISM Sites in the US and
Cash Position of
“We are pleased to announce that we have completed enrollment of the patients necessary to conduct the sample size re-estimation analysis in our PRISM trial and expect to announce the results of this analysis in mid-2020,” said
Key Product Pipeline Updates
- Phase 2b/3 PRISM trial of nalbuphine ER for severe pruritus in patients with prurigo nodularis: The pace of enrollment in the PRISM trial has been impacted by the COVID-19 pandemic with new patient screening and most patient enrollment temporarily halted. Patient screening restrictions have been lifted in
the United Statesand are in the process of being lifted in Europe. We expect many of our sites will restart patient screening and enrollment throughout May and June 2020. The protocol for the PRISM trial provides for a sample size re-estimation (SSRE) analysis once approximately 50% of the patients in the trial are evaluable for the primary endpoint. In light of the pandemic-related delays, we have decided to conduct the SSRE analysis once approximately 45% of the patients in the trial are evaluable for the primary endpoint. We have enrolled all the patients that will be included in the SSRE and will conduct the SSRE analysis once the last of these patients has completed the 14-week blinded treatment period. We expect the SSRE analysis will occur in mid-2020. We plan to provide guidance on our expected timing to report top-line data from the 14-week blinded treatment period of the PRISM trial when we report the results of the SSRE analysis in mid-2020 based on the results of the SSRE analysis and our progress in restarting patient screening and enrollment related to COVID-19.
- Phase 2 trial of nalbuphine ER for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): Due to the COVID-19 pandemic, and the specific at-risk nature of IPF patients, our clinical sites halted their enrollment and treatment of patients in this trial. We believe that enrollment may restart in the second half of 2020 and plan to provide guidance on the expected timing of top-line data from the trial in the second half of 2020.
First Quarter 2020 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the first quarter of 2020 were
General and administrative (G&A) expenses: G&A expenses for the first quarter of 2020 were
Net loss: For the first quarter of 2020, 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 and 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 impact of the COVID-19 pandemic on our clinical trials, business and operations, the expected timing of enrollment and the sample size 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 milestones for the Company’s other ongoing and planned clinical trials; 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 Trevi’s product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic and actions taken in response to the pandemic; 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||$||52,640||$||57,313|
Trevi Therapeutics, Inc.
Selected Statement of Operations Data
(amounts in thousands)
|Three Months Ended
|Research and development||$||6,019||$||3,338|
|General and administrative||2,620||1,474|
|Total operating expenses||8,639||4,812|
|Loss from operations||(8,639)||(4,812)|
|Other income (expense), net:||157||6|
|Loss before income tax benefit||(8,482)||(4,806)|
|Income tax benefit||9||4|