Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Phase 2a Randomized Placebo-Controlled Human Challenge Trial of the Respiratory Syncytial Virus L-Protein Inhibitor S-337395 for Respiratory Syncytial Virus Infection.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
backgroundS-337395 is a novel inhibitor of the respiratory syncytial virus (RSV) L-protein, and a potential oral antiviral against RSV. This phase 2a, randomized, double-blind, placebo-controlled, single-center, proof-of-concept trial conducted in the United Kingdom (April-October 2024) evaluated the efficacy, safety, and dose-response relationship of S-337395 against RSV infection in a human challenge model.
methodsHealthy adults aged 18-55 years meeting predefined eligibility criteria were inoculated with RSV-A Memphis 37b on Day 0. Nasal washes were collected for quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) assessment twice daily on Days 2-12 and once on Day 13. Participants were randomized 5:13:13:13:13 to receive S-337395 (1, 10, 30, or 300 mg) or placebo, once daily for 5 days upon evidence of infection. Efficacy analyses were conducted in participants with confirmed RSV infection in intent-to-treat infected (ITT-I) set. Safety was assessed in all randomized participants. Dose-response was evaluated across a wide dose range (1-300 mg).
resultsOf 114 randomized participants, 60 comprised the ITT-I set. Covariate-adjusted mean viral load area under the curve (VL-AUC) was significantly lower in the 30- and 300-mg groups by qRT-PCR (64.87% and 88.94% reductions, respectively, both P < .05) and by viral culture assay (72.32% and 86.17% reductions, respectively, both P < .05). Total symptom score AUC was 78.15% lower in the 300-mg group (P < .05). S-337395 was well-tolerated without any safety concerns.
conclusionsS-337395 significantly reduced viral load, viral titer, and symptoms, and was well-tolerated in this human challenge study. Clinical Trial Registration: ISRCTN24865912.
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