PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis
Exceeds Halfway Enrollment Milestone
Phase 2 Chronic Cough Trial in Patients with IPF Enrolled First New Subject Post-COVID-19 Restrictions
Cash Position Expected to Fund Operations into the First Half of 2022
“We are pleased with the continued progress of our clinical development programs,” said Jennifer L. Good, President and CEO of Trevi Therapeutics. “We recently announced significant developments in both of our ongoing clinical trials by surpassing halfway enrollment in our PRISM trial and enrolling the first new subject in our chronic cough trial in IPF since the study resumed after pausing due to COVID restrictions. We are focused on completing enrollment in both trials and preparing for the next steps in the development of Haduvio.”
Key Business Updates
- Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis: The Company has enrolled approximately 190 subjects in the trial and reaffirms its guidance that it expects to complete enrollment in the third quarter of 2021 and to report top-line data in the fourth quarter of 2021.
- Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Company resumed screening and enrolling patients in the trial following the pause in the trial due to COVID-19. The Company amended the study protocol to require fewer in-person visits by subjects as well as fewer procedures in order to facilitate the completion of the trial in an at-risk patient population for COVID-19. Additionally, the Company is assessing additional study sites in
Germanywhich could potentially accelerate enrollment and reduce the risks inherent with single-country recruitment during the COVID-19 pandemic.
Third Quarter 2020 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the third quarter of 2020 were
General and administrative (G&A) expenses: G&A expenses for the third quarter of 2020 were
Net loss: For the third quarter of 2020, the Company reported a net loss of
As previously announced, the Company will host a conference call and webcast today,
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.
Haduvio 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 Trevi’s clinical trials, business and operations; the expected timing of enrollment and for reporting top-line data from, Trevi’s Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; 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, the impact of the COVID-19 pandemic on Trevi’s clinical operations 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 the United States and foreign countries; uncertainties inherent in estimating Trevi’s cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Selected Balance Sheet Data
(amounts in thousands)
|Cash and cash equivalents||$||53,293||$||57,313|
Selected Statement of Operations Data
(amounts in thousands)
|Three Months Ended
||Nine Months Ended
|Research and development||$||4,828||$||5,650||$||15,768||$||14,516|
|General and administrative||2,416||2,000||7,528||5,363|
|Total operating expenses||7,244||7,650||23,296||19,879|
|Loss from operations||(7,244)||(7,650)||(23,296)||(19,879)|
|Other income (expense), net||(145)||280||26||352|
|Loss before income tax benefit||(7,389)||(7,370)||(23,270)||(19,527)|
|Income tax benefit||11||5||35||14|