Enanta Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Inanta Pharmaceuticals first quarter financial results conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to end the conference. Over to Ms. Carol Mussolini, Director of Investor Relations. Please go ahead, ma'am.

Thank you, Erica, and thanks for joining us this afternoon. The news release with our fiscal first quarter financial results was issued today and is available on our website. On the call today is Dr. Jay Luly, President and CEO, Paul Mallett, our Chief Financial Officer, and other members of the NANTA Senior Management Team. Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those statements. A description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC. An answer does not undertake any obligation to update any forward-looking statements made during this call. I'd now like to turn the call over to Dr. Jay Luly, President and CEO.

Thank you, Carol. Good afternoon, everyone. On today's call, I will discuss our recent clinical development progress on our lead RSV, NASH, and HPV compounds and upcoming milestones to look for in 2020. I'll begin with ADP938, the only N inhibitor for RSV in clinical development today. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults, and a condition for which there is currently no safe and effective therapy. At the end of 2019, we initiated our Phase IIb study named RSVP, which is a randomized, double-blind, placebo-controlled study of UDP938 Designed to enroll approximately 70 subjects up to the age of 75 years, randomized to receive either 800 milligrams of EDP938 or placebo for five days. The primary objective of the study is to evaluate the effect of EDP938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14-day study observation period. Antiviral efficacy will be evaluated as a key secondary endpoint. We're pleased to report that we've been able to identify many adult outpatients who have had cold-like symptoms that started within 48 hours of their visit to an RSVP study site. Identification of RSV patients in this group has been aided by the prompt on-site confirmation of RSV infection, which we have been providing by PCR testing. Unfortunately, it appears that the North American RSV season this winter peaked in December, which is approximately one to two months earlier than in most years. As a result, we have seen fewer RSV cases than expected, and therefore we are planning to continue the study into the southern hemisphere and have enrollment continue in all sites, with the goal now to have data in the first half of 2021. In addition to this study, we have also announced plans to initiate additional Phase II studies in pediatric patients and transplant patients by the end of this year concurrent with the RSVP study. We continue to believe that our end-protein inhibitor approach represents the best chance for success against RSV because it attacks the virus's replication machinery. Building on our success with viral infections such as HCV and our ongoing program with RSV, Last month, we introduced our newest drug discovery program, which is seeking therapeutics for human metapneumovirus, also known as HMPV. HMPV is a pathogen identified in 2001 that causes upper and lower respiratory tract infections in young children and the elderly, as well as in COPD, asthma, and immunocompromised patients. During 2020, we will continue to perform optimization of our current nanomolar inhibitor leads against this virus.