Enanta to update on R&D at JP Morgan

 

• Plans to Initiate First-in-Human Study of EDP-235, an Oral 3CL Protease Inhibitor Specifically Designed for the Treatment of COVID-19, in February 2022

• Completes Enrollment for RSVP, a Phase 2 Study of EDP-938 in Community-Acquired Respiratory Syncytial Virus (RSV) Infection in an Adult Population; Plans to Report Topline Data in the Second Quarter of 2022

• Announces RSV L-Protein Inhibitor, EDP-323, With Plans to Initiate a Phase 1 Study in the Second Half of 2022

Jay R. Luly, Ph.D., Enanta’s President and Chief Executive Officer, will provide an update across its pipeline of virology programs and plans for 2022 during Enanta’s presentation at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022 at 3:00 p.m. ET.

Pipeline Update and Business Review

Respiratory Syncytial Virus

• EDP-938, an N-protein inhibitor, is being evaluated in a broad clinical development program, consisting of three ongoing Phase 2 trials: RSVP, RSVPEDs and RSVTx.

• RSVP, which is designed to study the effect of EDP-938 on community-acquired RSV infection in an adult population, has completed enrollment and the company plans to report topline data in the second quarter of 2022.

• For RSVPEDs, a global, multi-center Phase 2 double-blind, placebo-controlled, dose-ranging study of EDP-938 in children aged 28 days to 24 months designed to enroll hospitalized and non-hospitalized infants and children with RSV, and RSVTx, a global, multi-center Phase 2b, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of EDP-938 in adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract, Enanta expects enrollment to continue into 2023.

• EPD-323, Enanta’s newest clinical candidate for RSV, is a novel oral, direct-acting antiviral selectively targeting the RSV L-protein, a viral RNA-dependent RNA polymerase that contains multiple enzymatic activities required for RSV replication. EDP-323 has shown nanomolar potency against RSV-A and RSV-B in vitro and is not expected to have cross resistance to other classes of inhibitors. EDP-323 has the potential to be used alone or in combination with other RSV mechanisms, such as EDP-938, to broaden the treatment window or addressable patient populations. Additional preclinical data will be shared at the Conference. Enanta expects to initiate a Phase 1 study in the second half of 2022.

COVID-19 (SARS-CoV-2)

• Enanta is initiating a Phase 1 study of EDP-235, its oral 3CL (or main) protease inhibitor (3CLpro or Mpro) specifically designed for the treatment of COVID-19, in February 2022. Recently presented data demonstrated that EDP-235 potently blocked the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells where an EC90 of 33 nanomolar was observed, positioning EDP-235 among the most potent direct-acting antivirals currently in development for SARS-CoV-2 infection. Preclinical studies showed that EDP-235 has good oral bioavailability without ritonavir boosting and favorable distribution into lung cells as well as other key target tissues, with expected once-daily human dosing. Importantly, EDP-235 has potent antiviral activity across a range of currently circulating SARS-CoV-2 variants, as well as other human coronaviruses.

Hepatitis B Virus

• In November 2021, Enanta announced positive final data from both Phase 1b studies of EDP-514 in viremic and NUC-suppressed chronic HBV patients. EDP-514 has Fast Track Designation from the FDA and the company is focused on identifying other compounds to develop with EDP-514 in combination regimens as a functional cure for chronic HBV.

Human Metapneumovirus (hMPV)

• Enanta is continuing the development of nanomolar inhibitors of human metapneumovirus, a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma. Clinical candidate selection is targeted for the second half of 2022.

Webcast Information
Enanta’s presentation will take place on January 11, 2022 at 3:00 p.m. ET. A live webcast of the presentation will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta’s website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 60 days.

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