Kinarus Therapeutics has dosed the first subject in the Phase II KINFAST clinical trial of the orally administered drug combination KIN001 in people with mild or moderate Covid-19 in an outpatient setting.
The placebo-controlled, multicentre, randomised, double-blind trial will enrol nearly 400 non-hospitalised patients at study sites in Germany and Switzerland.
These subjects will be randomised within five days of developing symptoms.
The trial will assess the safety, efficacy, and pharmacokinetic profile of KIN001 in participants.
The company anticipates carrying out an interim analysis on nearly 140 subjects.
Time to recovery as analysed by subject-reported daily symptoms will be the trial’s primary endpoint.
The number of subjects needing hospital admission for Covid-19 and the total burden of symptoms (severity and duration), as evaluated by the participant, will be included as other efficacy endpoints of the trial.
The KINFAST trial is partially funded through a non-diluting grant from the Swiss Federal Office of Public Health’s Programme for Covid-19 medicines.
KIN001 is an oral combination of two drugs, pamapimod and pioglitazone. It has synergistic antiviral and anti-inflammatory activities, as well as the potential to lower tissue fibrosis.
Pamapimod is a highly selective, investigational, small molecule, p38 mitogen-activated protein kinase inhibitor while pioglitazone is a marketed drug to treat type 2 diabetes.
Kinarus Therapeutics chief medical officer Thierry Fumeaux said: “With the initiation of this global Phase II programme, we are one step closer to achieving our goal of providing an easily administered oral drug with multiple synergistic mechanisms that fight and treat SARS-Cov2 infection, independent of the variant.
“KIN001 aims to prevent disease progression, thereby reducing disease severity as well as hospitalisations.”