SIR1-365 / Sironax - LARVOL DELTA

Safety and efficacy of selective RIPK1 inhibitor SIR1-365 in hospitalized patients with severe COVID-19: A multicenter, randomized, double-blind, phase 1b trial. (PubMed, J Intensive Med) - P1 | "Compare to placebo, SIR1-365 significantly increased arterial oxygenation from baseline to day 7 (least-squares mean change [standard error]: 109.4 [26.4] vs. -24.2 [23.6]; P=0.0095), significantly reduced hospitalization duration after treatment (mean±standard deviation: [4.7±3.7] days vs. [8.6±5.6] days; P=0.0145) and respiratory failure incidence (8.3% vs. 38.1%; two-sided P=0.0291) during the study, and numerically shortened the time to clinical improvement in World Health Organization ordinal scale (median: 5.0 days vs. 9.0 days, P=0.0766). SIR1-365 was well tolerated and demonstrated a trend toward quicker recovery than placebo in hospitalized patients with severe COVID-19.Trial Registration ClinicalTrials.gov number: NCT04622332."

Clinical • Journal • P1 data • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • RIPK1

A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19 (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Sironax USA, Inc. | Active, not recruiting ➔ Completed | Trial completion date: May 2022 ➔ Nov 2021

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • KIM1

A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19 (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Sironax USA, Inc. | Trial completion date: Dec 2021 ➔ May 2022

Trial completion date • Infectious Disease • Novel Coronavirus Disease • KIM1

A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19 (clinicaltrials.gov) - P1; N=45; Active, not recruiting; Sponsor: Sironax USA, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • KIM1

A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19 (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Sironax USA, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • KIM1