Kinarus Therapeutics Phase 2 KINFAST Covid-19 Clinical Trial Progress Update

MEDIA RELEASE

• KINFAST is evaluating KIN001 for reduction in severity and duration of Covid-19 symptoms
• KINFAST is actively enrolling in Germany/Switzerland

Basel, Switzerland, 20 February 2023. Kinarus Therapeutics Holding AG (SIX: KNRS) (Kinarus), a clinical-stage biopharmaceutical company developing novel therapeutics to treat viral, respiratory, and ophthalmic diseases, provided an update today on progress of its Phase 2 KINFAST trial of KIN001 in Covid-19.

Were pleased with the progress of KINFAST to date, said Thierry Fumeaux M.D. MBA, Chief Medical Officer of Kinarus Therapeutics, and former Chairman of the Covid-19 task force of the Swiss Federal Office of Public Health. Despite the evolution of Covid-19 to an endemic situation, reducing the duration and severity of SARS-CoV-2 infections remains a public health priority and a significant commercial opportunity. Our academic collaborators have shown that KIN001 is effective against newer SARS-CoV-2 variants. Since KIN001 targets host cell molecular pathways essential for viral replication, KIN001 remains effective against new variants. This is in contrast to vaccines and anti-viral drugs directed against SARS-CoV-2 itself.

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.

About the KINFAST trial

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.

About KIN001 and Covid-19

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.

Kinarus Therapeutics Holding AG (www.kinarus.com) was founded in 2017 by experienced pharmaceutical executives in Basel, Switzerland.  Pamapimod was initially discovered and developed by Roche. Kinarus possesses the exclusive worldwide license to pamapimod and has been issued patents covering the combination of pamapimod with pioglitazone. Kinarus licenses and develops late-stage clinical assets, increasing probability of clinical and regulatory success and reducing time-to-market.

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