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FDA Grants Fast Track Designation to Shionogi's Novel Anti-RSV Drug Candidate S-337395

• The FDA has granted Fast Track designation to Shionogi's S-337395, a novel oral anti-RSV drug candidate, to expedite its development and review process. • S-337395 targets a protein essential for RSV replication, demonstrating a dose-dependent reduction of RSV in the lungs in preclinical trials. • A Phase 2 trial is currently underway to assess the efficacy and safety of S-337395 in patients with RSV infection. • Fast Track designation allows for more frequent FDA consultations and staged submission of application materials, potentially accelerating its availability.

Shionogi & Co., Ltd. and UBE Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to S-337395, a novel, oral anti-respiratory syncytial virus (RSV) drug candidate. This designation aims to accelerate the development and review of S-337395 for treating RSV infections, addressing a significant unmet medical need, particularly in newborns, infants, and the elderly.

Significance of Fast Track Designation

The FDA's Fast Track program is designed to expedite the development and review of new drugs that treat serious conditions and fill unmet medical needs. For S-337395, this designation allows Shionogi and UBE to have more frequent consultations with the FDA and submit application materials in stages, potentially shortening the overall development timeline.

Mechanism of Action and Preclinical Data

S-337395 is an investigational oral drug that inhibits RSV replication by targeting a key protein essential for the virus's proliferation. Preclinical trials have demonstrated a dose-dependent reduction of RSV in the lungs, indicating its potential as an effective antiviral treatment.

Clinical Development: Phase 2 Trial

Currently, S-337395 is undergoing a Phase 2 clinical trial to evaluate its efficacy and safety in patients infected with RSV. The outcomes of this trial will be crucial in determining the drug's potential for regulatory approval and eventual clinical use.

RSV: An Unmet Medical Need

RSV is a common respiratory virus that affects most children by the age of two, with many experiencing recurrent infections. While generally causing mild, cold-like symptoms, RSV can lead to severe lower respiratory tract infections, such as bronchiolitis and pneumonia, particularly in vulnerable populations like newborns, infants, and the elderly. Effective antiviral treatment options for RSV are limited, highlighting the urgent need for new therapies.

Collaboration between Shionogi and UBE

Shionogi and UBE entered a strategic research collaboration in 2018 to develop novel anti-RSV drug candidates. In 2022, they announced the progression of S-337395 based on promising non-clinical study results. The companies are combining their expertise to expedite the development of S-337395 and make it available to patients as quickly as possible.
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Reference News

[1]
Receives U.S. FDA Fast Track Designation for the Novel Anti-Respiratory Syncytial Virus ...
shionogi.com · Oct 24, 2024

Shionogi & UBE announced FDA Fast Track designation for S-337395, an oral anti-RSV drug targeting RSV replication protei...

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