In a bid to expand its presence in the cardiometabolic disease space and strengthen its core business in diabetes and obesity, Novo Nordisk A/S is buying Corvidia Therapeutics Inc., of Waltham, Mass., for $2.1 billion, which includes a $725 million up-front payment.

Novo will receive all Corvidia’s outstanding shares. Payments to Corvidia’s shareholders could eventually hit $2.1 billion if Novo hits certain regulatory and sales milestones.

Corvidia’s lead candidate, ziltivekimab, a fully human monoclonal antibody directed against interleukin-6 (IL-6), is being developed to reduce risk of major adverse cardiovascular events in chronic kidney disease (CKD) patients with atherosclerotic cardiovascular disease and inflammation. Chronic kidney disease affects 14% of Americans, or about 49 million people.

Corvidia initiated patient screening for ziltivekimab (COR-001) in June 2019 for its ongoing phase IIb dose-finding study targeting residual inflammatory cardiovascular risk in adults with advanced CKD. The interventional, parallel assignment RESCUE trial has four arms. There is the matching placebo arm in the dose-finding trial, then increasing from 7.5 mg to 15 mg and 30 mg. About 240 participants with CKD stage 3-5 and high C-reactive protein levels, an inflammation marker, will receive once-monthly subcutaneous injections. The primary endpoint is reduction of inflammation at six months.

The study’s goal is to enable a global phase III cardiovascular outcomes trial to assess the impact of ziltivekimab on major adverse cardiovascular events in patients with elevated cardiovascular risk.

The phase II study’s estimated completion date is September.

Novo is divided into its diabetes and obesity care unit and its biopharmaceuticals unit. In 2016, diabetes and obesity care brought in about 80% of the company’s total sales, according to DRG. The company’s metabolism products accounted for more than 85% of sales.

In September 2014, Novo altered its focus by not following through on its planned expansion into immune and inflammatory spaces but has since signaled it will pursue areas that include nonalcoholic steatohepatitis, diabetic kidney disease and cardiovascular disease.

CKD competition

The CKD space has been active recently. In June, San Francisco-based Fibrogen Inc. and Astellas Pharma Inc. released updated data from three roxadustat clinical trials, including the phase III DOLOMITES study evaluating the efficacy and safety of roxadustat compared to darbepoetin alfa for treating anemia in nondialysis-dependent patients with stage 3-5 CKD. In the primary endpoint analysis, the study demonstrated noninferiority of roxadustat to darbepoetin alfa in the proportion of patients achieving correction of hemoglobin levels during the first 24 weeks of treatment. Roxadustat is an orally administered small-molecule HIF-PH inhibitor promoting erythropoiesis by increasing endogenous production of erythropoietin and improved iron absorption, transport and mobilization.

Also in the mix is Shield Therapeutics plc, of London, which released data in 2019 on its pivotal phase III AEGIS-CKD study showing hemoglobin levels were increased and maintained across 52 weeks of its oral iron replacement therapy, Feraccru, in patients with chronic iron deficiency anemia (IDA). The randomized, placebo-controlled, double-blind trial in CKD patients with IDA demonstrated superiority of Feraccru when the change in hemoglobin from baseline after 16 weeks of treatment with oral Feraccru (30 mg twice daily) was compared to placebo.

There is also Dimerix Ltd., of Melbourne, Australia, which is developing DMX-200, a chemokine receptor blocker for treating diabetic kidney disease. DMX-200 reduces inflammation that promotes the progression of CKD by blocking the signaling process allowing inflammatory cells to damage the kidney. Dimerix completed a phase IIa in 2017 in patients with a range of CKDs. All trial endpoints were achieved and DMX-200 was found safe and tolerable. A subgroup analysis found statistically and clinically significant efficacy signals were seen in patients with diabetes.

Corvidia’s previous financings

Corvidia closed on a $60 million series B in April 2018. Venrock led that financing and was joined by five new investors: Andera (formerly Edmond de Rothschild), Cormorant Asset Management, HBM Healthcare Investments, Fresenius Medical Care Ventures GmbH and Venrock Healthcare Capital Partners. Series A investors Apple Tree Partners, Medimmune (the global biologics R&D arm of Astrazeneca plc) and Paris-based Sofinnova Partners, the founding seed investor, also participated.

In 2015, Sofinnova, a venture cap firm, was Corvidia’s lone seed financial investor and stayed the largest shareholder until engineering the sale from its portfolio.

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