Kinarus Therapeutics is the latest company to swing and miss at the hospitalized COVID-19 opportunity. After seeing a who’s who of biopharma companies fail, the Swiss biotech has pulled the plug on a phase 2 trial in response to the lackluster efficacy data reviewed at an interim analysis.
The clinical trial, dubbed KINETIC, randomized hospitalized patients infected with SARS-CoV-2 to receive placebo or KIN001, a combination of the p38 MAPK signaling pathway inhibitor pamapimod and the approved diabetes drug pioglitazone. Kinarus designed the midphase study to assess the effect of the candidate on the proportion of patients who died or required ventilation in the four weeks after starting treatment.
An interim review by the independent data and safety monitoring board found the study is unlikely to link KIN001 to a statistically significant benefit, leading it to recommend stopping the trial early. Kinarus cited “the lower than anticipated incidence of the primary endpoint due to evolution of the current treatment landscape” as a factor in the failure.
Thierry Fumeaux, M.D., chief medical officer of Kinarus, went into more detail about the potential reasons for the inability to improve outcomes in hospitalized patients in a statement to disclose the discontinuation of the trial.
“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,” Fumeaux said.
Shares in Kinarus fell 14% in early trading in Switzerland, dragging the biotech’s share price down to 0.018 Swiss francs ($0.018). However, management at Kinarus thinks the rationale for developing KIN001 remains intact and, with the failed COVID-19 trial revealing a “favorable” safety profile, is continuing to move the candidate forward.
Enrollment in a phase 2 trial in ambulatory COVID-19 patients is continuing, and the hospital data have had no impact on Kinarus’ plans to develop the candidate as a treatment of conditions including wet age-related macular degeneration and idiopathic pulmonary fibrosis.