Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and 2024 Outlook at the 42nd Annual J.P. Morgan Healthcare Conference - Seite 2

• Enanta plans to pursue any future COVID-19 efforts in the context of a collaboration, including the development of EDP-235, an oral, once-daily, Phase-3-ready, 3CL protease inhibitor which has been granted Fast Track designation by the FDA.

Hepatitis B Virus

• Enanta’s goal is to achieve a functional cure for chronic Hepatitis B infection by identifying additional mechanisms for development in a combination regimen with EDP-514, its potent core inhibitor which has Fast Track designation from the FDA. Advancing this program depends upon accessing an additional mechanism through a licensing or partnership agreement.

Immunology

Chronic Spontaneous Urticaria

• Today, Enanta announced its expansion into immunology with its first program in chronic spontaneous urticaria (CSU), a severely debilitating, chronic inflammatory skin disease. CSU is estimated to affect 0.5% to 1% of the global population, and there is a substantial unmet need for an efficacious oral agent.¹ Currently, approximately half of patients are not controlled with antihistamines, and a minority of those patients are treated with one indicated biologic.² Enanta’s approach is to treat CSU by depleting mast cells through KIT inhibition, addressing a primary driver of the disease. The company has developed novel, potent and selective oral inhibitors of KIT, which are now being optimized in preclinical development. Enanta’s prototype inhibitors potently inhibit activity in both binding and cellular function assays and are highly selective for KIT versus other kinases. These inhibitors also demonstrate strong in vitro and in vivo ADME properties.
• Enanta will present new preclinical data on its prototype KIT inhibitor at the J.P. Morgan Conference and is targeting the selection of a development candidate in 2024.

The Company expects the following milestones across its pipeline in 2024:

• 3Q 2024:
  • Report topline data for one or both of the Phase 2 studies of zelicapavir, if this winter continues to be a more normal RSV season in the Northern Hemisphere
  • Report topline data from the Phase 2a challenge study of EDP-323
• 2024:
  • Select a KIT inhibitor development candidate for CSU
  • Introduce a second immunology program

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