Therapeutics Holding AG provided an update on progress of its Phase 2 KINFAST trial of KIN001 in Covid-19. KINFAST is currently enrolling patients at clinical sites in Switzerland and Germany. As of 16 February, 8 sites have been opened, 5 of which are actively enrolling patients.

Since the beginning of the year, the rate of patient recruitment has increased significantly. The current projection, dependent on recruitment rate and incidence of SARS-CoV-2 infections, is for KINFAST to report results of a pre-planned interim analysis for efficacy and safety prior to the end of 2023. Notably, no safety concerns associated with KIN001 have been identified among the patients who have completed the two-week treatment regimen.

KINFAST is a Phase 2 multi-center, randomized, double-blind, placebo-controlled outpatient study to evaluate the efficacy, safety, and pharmacokinetic profile of KIN001 in patients with mild or moderate Covid-19. The study enrols non-hospitalized patients exhibiting mild to moderate symptoms and who test positive for SARS-CoV-2 infection. The primary endpoint is the reduction in severity and duration of Covid-19 symptoms. Other efficacy endpoints include number of patients requiring hospitalization with or without respiratory support.

The KINFAST trial was initiated with the support of a grant from the Programme for Covid-19 medicines of the Swiss Federal Office of Public Health. KIN001 is a patented combination of pamapimod, a highly selective investigational small molecule inhibitor of p38 mitogen-activated protein kinase (p38 MAPK), and pioglitazone, a marketed drug for the treatment of type 2 diabetes. KIN001 has strong antiviral efficacy and equal potency against the original SARS-CoV-2 strain and variants of concern (VOC), including the delta and the omicron subvariants BA.2 and BA.5. In contrast to direct antivirals and monoclonal antibody therapies, KIN001 targets host cell pathways essential for viral replication, and has demonstrated sustained and durable potency against emerging SARS-CoV-2 variants.