First Hospitalized COVID-19 Patient Dosed with KIN001 in Phase 2 Study
Apr 13, 2021 4:02 PM
First Interim data expected for Q4 2021 and full Phase 2 data planned for early 2022
KIN001, a combination of p38 MAPK inhibitor pamapimod with a second drug has a proven safety record with potential to address a broad range of indications
Kinarus is preparing additional Phase 2 studies for KIN001 in COVID-19 for out-patients and other therapeutic indications with key unmet medical need such as wet-AMD (ophthalmology) and IPF (Idiopathic Pulmonary Fibrosis)
Basel, Switzerland, April 13, 2021. Kinarus AG, a Swiss clinical-stage biopharmaceutical company and owner of KIN001, a differentiated therapeutic candidate enabling a broad range of treatments, announced today the enrolment and dosing of the first patient in the company’s Phase 2 study for KIN001 in COVID-19 in hospitalized patients. KIN001 is an orally administered combination of the p38 MAPK inhibitor pamapimod with a second drug and has potential applications for a broad range of indications including viral, respiratory and ophthalmic diseases.
“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 hospitalized setting. We continue the development of KIN001 with full focus in order to make it available to patients as early as next year.”
Conducted in Europe, the trial is a Phase 2 randomized, placebo-controlled study to evaluate the efficacy of KIN001 for hospitalized patients infected with COVID 19. The phase 2 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.
Further, Kinarus is developing the protocol and is in discussions with international organizations 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).
KIN001 is a novel combination of pamapimod with a second drug. Pamapimod is a highly-selective inhibitor of p38 mitogen-activated protein kinase (p38 MAPK) which Kinarus has licensed. The p38 MAPKs are central regulators of the cellular response to inflammation, viral infection, and stress signals. They have also been shown to play important roles in biological processes such as cell proliferation, chemotaxis, tissue fibrosis, and vasculogenesis. Kinarus’ patented combination of pamapimod with the second drug improves the efficacy and durability of response, providing a unique and differentiated therapeutic in a number of indications. KIN001 has demonstrated anti-inflammatory, anti-fibrotic and antiviral activity. These favorable properties are critical for COVID-19 patients in targeting the multiple facets of the disease and Kinarus has rapidly advanced KIN001 to address the urgency of the pandemic, including its long-term adverse consequences, ‘long COVID’. Pre-clinical models have demonstrated the potential of KIN001 in wet AMD where it may offer an oral treatment alternative to current therapies by extending the treatment intervals between direct injection into the eye required by standard of care, and in IPF where it has reduced lung fibrosis. Protocols have been prepared for the clinical evaluation of KIN001 in these indications.
Kinarus AG is a Swiss clinical-stage biopharmaceutical company focused on bringing differentiated treatments to patients suffering from viral, respiratory or ophthalmic diseases. Kinarus’ differentiated therapeutic candidate KIN001 has broad potential to transform numerous therapeutic areas. The company has patent protected and is preparing the application of KIN001 in multiple indications with important unmet medical needs. Swiss-based Kinarus is privately owned. The Board of Directors of the company is currently evaluating different financing options.
For more information, please visit the company’s website at www.kinarus.com.
CEO, Kinarus AG