NEW HAVEN, Conn., Aug. 9, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of Lisa Delfini, CPA, as Chief Financial Officer and Danine Summers, as Vice President, Medical Affairs. Ms. Delfini will lead the accounting and finance operations. Ms. Summers will be responsible for educating the medical community on Haduvio's data and development programs through publications, congresses and relationship building with key opinion leaders.
"We are thrilled to welcome Lisa and Danine to our skilled senior leadership team," said Jennifer L. Good, President and Chief Executive Officer of Trevi. "Their knowledge and experience will be instrumental as we move towards enrollment completion and topline data in our Phase 2b/3 PRISM trial and Phase 2 CANAL trial and preparing for the next stage of growth at Trevi."
Ms. Delfini joins Trevi with 30 years of experience in the financial sector. Her background includes helping public and private companies with finance transformation and preparing for and executing capital raising activities, acquisitions, and other complex financial and accounting matters. As a Financial Accounting and Advisory Services Partner at Marcum LLP, Ms. Delfini led a team of professionals who provided advisory services on financial activities to companies. In this role, she served as interim CFO, CAO or controller for companies in multiple sectors, including pharmaceuticals. Previously, Ms. Delfini worked at General Electric where she was the Global Controller for the GE Corporate Technical Center of Excellence (TCOE) and then became the Global Controller for GE Industrial Solutions. Ms. Delfini began her career at Deloitte & Touche LLP where she worked for 16 years and completed her time there as a Client Service Partner. She holds a B.S. in Accounting from Lehigh University and is a Certified Public Accountant in the State of Connecticut.
Ms. Summers is an accomplished Medical Affairs executive whose success in leading medical affairs operations, key opinion leader communication and new market development spans throughout start-up, growth, turnaround, and acquisition phases. Ms. Summers has spent the majority of her career working in dermatology-focused companies. Before joining Trevi, she held varying senior management roles in medical affairs and marketing at companies such as Anacor Pharmaceuticals, Menlo Therapeutics, Medicis Pharmaceutical, Connetics Corporation, VICOM/FCB and Roche Pharmaceuticals. Ms. Summers was instrumental in the development of Medical Affairs departments and demonstrated her ability to connect with healthcare professionals to educate them on their products' profiles. Ms. Summers holds an M.B.A. in Marketing from the Golden Gate University and a B.A. in Psychology, Business Minor from San Jose State University.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis (PN) and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.
Haduvio, an investigational therapy, 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 the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Parenteral nalbuphine is not currently classified as a controlled substance by the DEA in the United States and by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for nalbuphine ER. Haduvio is an investigational therapy that has been granted Fast Track designation by the FDA for the proposed indication of reduction of moderate to severe pruritus in patients with PN. Its safety and efficacy have not been evaluated by any regulatory authority.
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 Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates, 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 regarding fast track designation and the effect such status could have on the regulatory review or approval process; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to continue as a going concern and its obligations under its loan facility; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended March 31, 2021 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.
Trevi Therapeutics, Inc.
SOURCE Trevi Therapeutics, Inc.