Immunic has reported that main analysis data from Phase II CALVID-1 trial of its oral, selective oral DHODH inhibitor, IMU-838, showed evidence of clinical activity in hospitalised patients with moderate Covid-19.
The randomised, placebo-controlled, double-blind trial analysed IMU-838 as an oral treatment option for Covid-19 and to support the potential use of it for treating current and potential viral pandemic threats.
The main analysis of the trial had a total of 204 participants, with 202 patients receiving at least one dose of the study drug. In the trial, 99 subjects were given 45mg of IMU-838 daily while 103 subjects received placebo.
Immunic noted that primary and key secondary endpoints were not evaluable owing to reduced rates of serious complications in the population of hospitalised patients with moderate Covid-19.
The clinical activity of IMU-838 was confirmed based on multiple secondary clinical endpoint assessment. Data showed that 18.5% of the patients receiving IMU-838 had clinical recovery at day seven versus 12.8% in the placebo arm.
At day 28, 71.3% of the patients in IMU-838 treatment arm recovered versus 66.7% in the placebo arm.
Furthermore, IMU-838 treatment arm had reduced time to clinical improvement versus placebo and the incremental benefit improved over time.
The drug was found to be safe and well-tolerated in hospitalised patients with moderate Covid-19.
Immunic CEO and president Daniel Vitt said: “I am truly excited to report that our CALVID-1 trial showed clinical activity of IMU-838 in hospitalised patients with moderate Covid-19 and also reproduced in this patient population the drug’s already established favourable safety and tolerability profile.
“The reductions in hospitalisation and clinical recovery times observed thus far in our CALVID-1 trial are clinically meaningful and particularly interesting in the high-risk and elderly populations.”
Last June, Immunic initiated dosing of patients in the Phase II CALVID-1 clinical trial of IMU-838 to treat patients with Covid-19.
In a separate development, RedHill Biopharma has dosed the first patient in its US Phase II/III study of orally administered RHB-107 (upamostat) for treating patients with symptomatic Covid-19 in an outpatient setting.
The two-part, multicentre, randomised, double-blind, placebo-controlled, parallel-group study will evaluate the safety and efficacy of RHB-107.