Calliditas Therapeutics is a biopharmaceutical company developing treatments for orphan renal and hepatic diseases, whose lead candidate successfully completed a Phase 3 trial for the treatment of autoimmune renal disease IgA nephropathy.

Genkyotex is developing setanaxib, a small molecule targeting NOX enzymes whose inhibition could treat fibrotic and inflammatory diseases.

Genkyotex completed a Phase 2 trial in Primary Biliary Cholangitis and has started two investigator-initiated trials in idiopathic pulmonary fibrosis and diabetic kidney disease.

The addition of setanaxib to Calliditas Therapeutics’ product portfolio will help strengthen its position in rare kidney and liver diseases, adding new promising candidates in core targeted indications.


About Calliditas Therapeutics

Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT).

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About Genkyotex

Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the Euronext Paris and Euronext Brussels markets. Its unique platform enables the identification of orally available small-molecules which selectively inhibit specific NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration. Genkyotex is developing a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate, setanaxib (GKT831), a NOX1 and NOX4 inhibitor has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease). Based on its positive Phase II results, a phase 3 trial with setanaxib in PBC is being planned. Setanaxib is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD). A grant from the United States National Institutes of Health (NIH) of $8.9 million was awarded to Professor Victor Thannickal at the University of Alabama at Birmingham (UAB) to fund a multi-year research program evaluating the role of NOX enzymes in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs. The core component of this program is a Phase 2 trial with setanaxib in patients with IPF scheduled to recruit patients in the course of 2020. This product candidate may also be active in other fibrotic indications.

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Hervé Ronin

Investment Banking

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Romain Ellul

Investment Banking

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Cosme Rosellini

Equity Capital Markets

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Mickael Dubourd

Investment Banking

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Jonathan Pavillard

Investment Banking

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