Basel-based Kinarus AG is investigating the efficacy its KIN001 for hospitalised patients infected with COVID-19 in a phase 2 study in Europe. KIN001, a differentiated therapeutic candidate enabling a broad range of treatments including viral, respiratory and ophthalmic diseases.
Kinarus AG is a clinical-stage biopharmaceutical company focused on bringing novel treatments to patients suffering from viral, respiratory, and ophthalmic diseases. The company's unique and innovative combinatorial therapeutic candidate KIN001 is an orally administered combination of the p38 MAPK inhibitor pamapimod with a second generic drug. The therapy has potential applications for a broad range of indications including viral, respiratory and ophthalmic diseases.
The startup recently announced the enrolment and dosing of the first patient in the its Phase 2 study for KIN001 in hospitalised patients with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2) in Europe. The study plans to recruit approximately 400 patients. The first interim analysis after about 40 patients which is focusing primarily on safety is expected for Q4 2021. Final results for the study are planned for Q1 2022 with the primary endpoints being the need for intubation, high pressure oxygen as well as mortality. The study can be followed here.
"The initiation of the Phase 2 study in COVID-19 marks a key milestone for our company and a first step to highlight the broad application platform for KIN001," commented Alexander Bausch, CEO of Kinarus. "Assuming we are able to confirm our exciting preclinical results in a fully powered phase 2 study, we can offer a convenient oral solution that is not only antiviral, but also anti-inflammatory and anti-fibrotic to the significant number of COVID-patients in need. KIN001 would overcome the shortfalls of existing therapies and offer a solution for the severely ill patients in a hospitalised setting. We continue the development of KIN001 with full focus in order to make it available to patients as early as next year.”
Additional Phase 2 studies for KIN001 in COVID-19 for out-patients
Further, Kinarus is developing the protocol and is in discussions with international organisations regarding the sponsorship of a complementary Phase 2 for mild-to-moderate COVID-19 patients. Clinical development planning in COVID-19 is ongoing with additional trials in other settings being planned.
In addition to evaluating the effectiveness of KIN001 in COVID-19 patients, Kinarus has planned complementary Phase 2 clinical studies to evaluate the application of KIN001 for patients with age-related macular degeneration (wet-AMD) as well as in Idiopathic Pulmonary Fibrosis (IPF).
(Press release)
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