Kinarus Therapeutics discontinues Phase 2 Kinetic study of KIN001

KIN001 is a patented combination of pamapimod, a highly selective clinical-stage small molecule inhibitor of the p38 MAPK signaling pathway, and pioglitazone, a marketed drug for the treatment of type 2 diabetes. Kinarus has discovered that combining pamapimod with pioglitazone results in synergistic efficacy and increased durability of response in preclinical models representing several disease indications. In SARS-CoV-2 infected cells, inhibition of p38 by KIN001 significantly reduces viral replication demonstrating synergistic activity vs. the single drugs. KIN001 also can blunt the overactive inflammatory response in ambulatory patients with COVID‑19, with potential to reduce disease duration, incidence of “long Covid”, hospitalization and long-term morbidity.

An independent Data and Safety Monitoring Board (“DSMB”) has completed Kianrus’ prespecified data review for the Phase 2 KINETIC study in hospitalized COVID-19 patients and has recommended its discontinuation. They concluded that there is low probability to show statistically significant benefit with a reasonable number of hospitalized COVID-19 patients, in light of the lower than anticipated incidence of the primary endpoint due to the evolution of the current treatment landscape. It, therefore, recommends that the KINETIC study be discontinued.

Safety data from KINETIC study indicate a favourable profile, with a balanced incidence of treatment-emergent adverse events (TEAEs) between study groups. 

“While it is disappointing that KIN001 has not shown sufficient signs of efficacy in the KINETIC study, it is important to remember that hospitalized COVID-19 patients have severe disease with highly complicated pathophysiology. As many of our peers have learned since the beginning of the pandemic, it has become challenging to show the impact of therapeutic intervention at the current pandemic stage, given the disease characteristics in COVID-19 patients with severe disease. Moreover, there are also now relatively smaller numbers of patients that meet enrolment criteria, since fewer patients require hospitalization, in contrast to the situation earlier in the pandemic,” said Dr Thierry Fumeaux, Chief Medical Officer of Kinarus. 

“For these reasons, we are continuing to study KIN001 as planned in KINFAST, a second Phase 2 study in ambulatory COVID-19 patients who are not hospitalized” remarked Dr Fumeaux. “The goal of KINFAST is to reduce the time to recovery, as well as the severity of disease in mild to moderate symptomatic SARS-CoV-2 positive individuals. Currently, the course of COVID-19 in the majority of patients does not require hospitalization, with consequences for the single patient but also for society. This substantially increases the treatable population and, therefore, the potential for a significant benefit on this clinically and pharmacoeconomically relevant outcome.”

(Press release)