MEDIA RELEASE

• Researchers at Friedrich-Alexander-Universität Erlangen-Nürnberg and Kinarus report new antiviral data of KIN001 against SARS-CoV-2 Omicron BA.2 and BA.5 subvariants
• KINFAST Phase 2 trial of KIN001 in ambulatory COVID-19 patients is actively recruiting

Basel, Switzerland, 6 December 2022 -- Kinarus Therapeutics Holding AG (SIX: KNRS) (“Kinarus”), a clinical-stage biopharmaceutical company developing novel therapeutics to treat viral, respiratory, and ophthalmic diseases, announced new preclinical data showing KIN001’s strong antiviral efficacy against the SARS-CoV-2 Omicron subvariants BA.2 and BA.5.

Prof. Ulrich Schubert from the Institute of Clinical and Molecular Virology at the Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, and principal investigator of the study, said: “This research complements our previously published data and demonstrates ongoing durability of KIN001’s antiviral activity against the Omicron BA.2 and BA.5 subvariants. The BA.5 subvariant currently accounts for about one-quarter of Covid-19 cases in the US.”

Kinarus is conducting a Phase 2 trial of KIN001 to treat ambulatory COVID-19 patients (“KINFAST”) with a positive SARS-CoV-2 test and is actively recruiting in Switzerland and Germany. The primary endpoint of the study is the reduction in the severity and duration of Covid-19 symptoms.

"Our main focus continues to be on exploring all options to enable the initiation of wet AMD and IPF Phase 2 clinical trials with KIN001. Nevertheless, it is highly encouraging that KIN001 has demonstrated equivalent activity against the SARS-CoV-2 Omicron BA.2 and BA.5 subvariants.” said Alexander Bausch, PhD, CEO of Kinarus. “In the US, emerging subvariants BQ.1 and BQ.1.1 are quickly becoming the dominant cause of new infections. These preclinical data suggest that KIN001 is likely to also be effective against these variants. Patients enrolling in our phase 2 KINFAST study of KIN001 may benefit regardless of current or future variants which underly their infection.”

KIN001 is an orally available 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 may fight Covid-19 in three ways: anti-viral activity may prevent viral replication; anti-inflammatory activity may reduce excessive inflammation (e.g. “cytokine storm”); anti-fibrotic activity may reduce long-term tissue damage decreasing the likelihood of “long COVID” symptoms. In contrast to vaccines, antibodies, and nucleic acid-based therapies, which target viral proteins, KIN001 targets host cell pathways essential for viral replication.

These new data add to a body of published research that support the role of p38 MAPK in the SARS-CoV-2 lifecycle and the virus-blocking effects of p38 MAPK inhibitors. Since pioglitazone enhances the durability and antiviral effects of pamapimod, KIN001 may be a more effective treatment than single agents targeting only p38 MAPK.

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 the molecule and has developed KIN001, a combination with pioglitazone. The strategy of Kinarus is to license and develop late-stage clinical assets in new indications, increasing the probability of clinical and regulatory success and reducing time-to-market.

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