Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and 2024 Outlook at the 42nd Annual J.P. Morgan Healthcare Conference

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs with an emphasis on indications in virology and immunology, today announced that Jay R. Luly, Ph.D., Enanta’s President and Chief Executive Officer, will provide an update across its pipeline and plans for 2024 during Enanta’s presentation at the 42^nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 at 9:45 a.m. PT.

“Entering 2024, Enanta is poised to achieve significant value creation, starting with advancement of our robust RSV program which has multiple clinical catalysts expected over the year, and continuing with our expansion into immunology. Our foundational capabilities in virology and small molecule drug development transition well to immunology, an adjacent field where we can leverage our core strengths. We are excited to announce our first immunology program developing oral KIT inhibitors for the treatment of CSU, a severely debilitating chronic inflammatory skin disease characterized by hives, with limited effective treatment options” said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. “This program has the potential to bring an efficacious oral treatment to the millions of patients affected by CSU worldwide, and potentially other mast cell driven indications, and we are eager to make an impact in this field. Additionally, we are progressing our RSV program of zelicapavir, also known as EDP-938, with enrollment ongoing in RSVPEDs, a Phase 2 study in pediatric RSV patients, and RSVHR, a Phase 2 study in high-risk adults with RSV. Assuming the Northern Hemisphere RSV season continues on a more normal course, we expect to have data in one or both of these trials in the third quarter of this year. We are also advancing EDP-323, our L-protein inhibitor, in a human challenge study and are targeting topline data in the third quarter of this year. Finally, with our strong cash reserves, we are well-positioned to build value by delivering highly differentiated oral therapeutics through innovative drug discovery.”

Pipeline Updates

Virology

Respiratory Syncytial Virus

• Enanta is progressing multiple clinical programs targeting populations at high-risk for serious outcomes from RSV infection. Its lead candidate, zelicapavir, an oral, N-protein inhibitor, is being evaluated in two ongoing Phase 2 clinical trials, RSVPEDS and RSVHR.

• RSVPEDs is a Phase 2, randomized, double-blind, placebo-controlled study in hospitalized and non-hospitalized pediatric RSV patients, and RSVHR is a Phase 2b randomized, double-blind, placebo-controlled study in adults with RSV infection who are at high risk of complications, including the elderly and/or those with congestive heart failure, chronic obstructive pulmonary disease, or asthma.
• Enanta expects to complete enrollment in one or both of these ongoing Phase 2 studies of EDP-938 and to report data in the third quarter of 2024, if this winter continues to be a more normal RSV season in the Northern Hemisphere.

• Enanta’s second RSV candidate, EDP-323, an oral, L-protein inhibitor, is on track to report topline data from its ongoing Phase 2a challenge study in the third quarter of 2024. This randomized, double-blind, placebo-controlled, human challenge study is designed to assess safety, pharmacokinetics (PK), and changes in viral load measurements and baseline symptoms in up to 114 healthy adult subjects who will be infected with RSV. The advancement of EDP-323 into a challenge study follows positive Phase 1 data which demonstrated favorable safety, tolerability, and PK supportive of once-daily dosing, with high exposure multiples.

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