Announced Positive Outcome of Sample Size Re-Estimation Analysis for PRISM Trial
Strong Enrollment in PRISM Trial After Lifting of COVID-19 Restrictions
“We are pleased with how the Trevi team was able to manage the continued execution of the PRISM trial in the face of the COVID-19 pandemic restrictions. The Company announced the positive outcome of the sample size re-estimation analysis and continued to activate clinical sites virtually,” said
Key Business Updates
- Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis: The Company completed the pre-specified sample size re-estimation (SSRE) analysis in July and based on the recommendation of the independent Data Monitoring Committee, we increased the trial size from the initial target enrollment of 240 to 360 subjects to maintain statistical power for the primary endpoint. The pace of enrollment has accelerated since the removal of most COVID-19 screening and enrollment restrictions and approximately 155 subjects have been enrolled in the study. We expect to complete enrollment in the third quarter of 2021 and 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 is amending the study protocol to reduce the number of in-person visits to facilitate this study being completed in an at-risk patient population for COVID-19. The Company is planning for a restart of this trial in the second half of 2020.
- Entered into
$14 millionterm loan with Silicon Valley Bank: The Company entered into a $14 millionterm loan with Silicon Valley Bankon August 13, 2020which will bolster our balance sheet and extends our cash runway into the first half of 2022. The term loan requires monthly interest-only payments through February 28, 2022, followed by monthly payments of principal and interest until February 1, 2024. Interest on the term loan initially accrues at a floating per annum rate of the greater of (i) the prime rate plus 1.0% and (ii) 4.25%. Other material terms related to the term loan can be found in the Company’s Form 10-Q.
Second Quarter 2020 Financial Highlights
Cash position: As of
Research and development (R&D) expenses: R&D expenses for the second quarter of 2020 were
General and administrative (G&A) expenses: G&A expenses for the second quarter of 2020 were
Net loss: For the second 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 our 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; 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, 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
Trevi Therapeutics, Inc.
Selected Balance Sheet Data
(amounts in thousands)
|Cash and cash equivalents||$||44,180||$||57,313|
Selected Statement of Operations Data
(amounts in thousands)
|Three Months Ended
||Six Months Ended
|Research and development||$||4,921||$||5,528||$||10,940||$||8,866|
|General and administrative||2,492||1,889||5,112||3,363|
|Total operating expenses||7,413||7,417||16,052||12,229|
|Loss from operations||(7,413)||(7,417)||(16,052)||(12,229)|
|Other income (expense), net||14||66||171||72|
|Loss before income tax benefit||(7,399)||(7,351)||(15,881)||(12,157)|
|Income tax benefit||15||5||24||9|