Astrazeneca plc spinout Corvidia Therapeutics Inc.'s $60 million in series B money should let the company "expand into earlier stages of chronic kidney disease [CKD] and apply our scientific approach further into areas of heart failure," CEO Marc de Garidel told BioWorld, adding that the company is "investing to further build our pipeline assets and accelerate some of these therapies into clinical trials."

The Waltham, Mass.-based firm added five new investors while marching toward completion of a phase II trial with monoclonal antibody COR-001 for a genetically defined patient population living with advanced CKD. Phase II data likely will be reported in the second half of this year, and Corvidia is talking with the FDA about next steps.

"This is a biologic injectable therapy targeting inflammation in patients with advanced renal disease," De Garidel said. "In addition to an increased risk of heart failure, advanced kidney disease patients who have inflammation often have a significantly decreased quality of life, experiencing anemia, chronic exhaustion, muscle weakness, loss of appetite and depression. We believe that by applying our understanding of the networks of genetic variation, we can for the first time address the chronic inflammation of advanced kidney disease in a uniquely at-risk population," thus improving the picture for needful patients.

Other candidates wait behind COR-001. De Garidel said the company has an "active preclinical program" but for competitive reasons prefers not to disclose details. "Our pipeline remains focused on cardiovascular and renal diseases," he said. The company emerged from London-based Astrazeneca and raised $26 million in a February 2016 series A round. Originally developed by Astrazeneca's biologics arm, Medimmune, COR-001 had reached phase I trials in the hands of the parent pharma firm for an indication other than the one Corvidia opted to pursue. (See BioWorld Today, Feb. 19, 2016.)

Corvidia has made changes in top management with the closing of the series B. Four of the founding executive team members have been named to new roles: Rahul Kakkar bears the titles of chief medical officer and chief strategy officer; Matt Devalaraja's doorplate says vice president and head of research and development; Ram Aiyar takes on head of business development duties. Corvidia's former CEO, Michael Davidson, took the position of chief science officer upon the appointment of de Garidel.

Fairly hot as a therapeutic space, CKD made headlines this month when Shield Therapeutics plc, of London, heard good news from the FDA, which sifted through a revised analysis of phase III data with the oral iron replacement therapy Feraccru in patients with CKD and decided the firm need not undertake new trials – even though top-line results of the 168-patient Aegis-CKD study, published in February, showed that Feraccru failed to demonstrate a statistical difference in hemoglobin levels from baseline compared to placebo, at 0.45 g/dL vs. 0.15 g/dL (p=0.01686). In a later per-protocol analysis, Shield found 21 patients in the first 16-week, placebo-controlled portion who experienced pre-specified events, including receiving blood transfusions or treatment with erythropoietin, that could have meant excluding them from the study. (See BioWorld, Feb. 13, 2018, and April 9, 2018.)

Fibrogen Inc. and U.S. partner Astrazeneca own another juicy prospect in CKD: roxadustat for anemia associated with the condition. Important data should roll out in the fourth quarter, with a filing for approval possible next year if the oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor hits the mark. Tokyo-based Astellas Pharma Inc., a collaborator with Fibrogen since 2004 (first for Japan and later for Europe, the Middle East, the Commonwealth of Independent States and South Africa), also has experiments underway. (See BioWorld, April 2, 2018.)

Also in the HIF space is Akebia Therapeutics Inc., of Cambridge, Mass., with lead candidate vadadustat targeting CKD anemia in phase III trials, including the Protect studies for nondialysis-dependent patients and the Innovate studies for dialysis-dependent (DD) patients. In addition, the phase II Forward study has begun in DD patients who are hyporesponsive to erythropoiesis-stimulating agents. The phase III Trilogy experiment will assess the safety and efficacy of vadadustat three times per week vs. an active comparator in DD patients. Akebia aims for full enrollment of the pivotal Innovate and Protect studies by the end of this year, with top-line data expected in 2019, subject to the accrual of major adverse cardiac events, and market launch anticipated in 2020, assuming approval. Forward and Trilogy, with recently enhanced study designs, should kick off in this quarter and late 2018, or early 2019, respectively. H.C. Wainwright analyst Ed Arce said in a report on Akebia last week that he finds the valuation "compelling. Recall, the expanded enrollment and patient criteria for these two studies were established to provide additional characterization and differentiation of vadadustat and further strengthen its commercial position" among existing CKD players.

Corvidia's approach stands alone, though, because of the genetic targeting factor, which also may mean avoiding the large CKD trials often demanded by U.S. gatekeepers. Venrock led the series B and was joined by new investors Andera (formerly Edmond de Rothschild), Cormorant Asset Management, HBM Healthcare Investments, Fresenius Medical Care Ventures GmbH, and Venrock Healthcare Capital Partners. Investors in the series A also took part in the series B, including Apple Tree Partners, Astrazeneca's Medimmune arm and Sofinnova Partners, the founding seed investor.

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