Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease

Summary

A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.

Timeline

Start

2021-02-16

Primary completion

2021-12-28

Completion

2021-12-28

Outcome

Met primary endpoint

Stopped: “Part A complete; corporate decision made to cancel Part B.”

release “Phase 2 part of Phase 2/3 study of once-daily oral RHB-107 in symptomatic COVID-19 successfully met the study's primary endpoint” redhillbio.com ↗

release “The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results” redhillbio.com ↗

Publications

• Results Plasse TF, Delgado B, Potts J, Abramson D, Fehrmann C, Fathi R, McComsey GA. A randomized, placebo-controlled pilot study of upamostat, a host-directed serine protease inhibitor, for outpatient treatment of COVID-19. Int J Infect Dis. 2023 Mar;128:148-156. doi: 10.1016/j.ijid.2022.12.003. Epub 2022 Dec 19.
• Results Plasse TF, Fathi R, Fehrmann C, McComsey GA. Upamostat: a serine protease inhibitor for antiviral, gastrointestinal, and anticancer indications. Expert Opin Investig Drugs. 2023 Jul-Dec;32(12):1095-1103. doi: 10.1080/13543784.2023.2284385. Epub 2023 Dec 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Upamostat	Small molecule	200 mg	Oral
Subject	Upamostat	Small molecule	400 mg	Oral

Indications