SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Tricida, Inc., a privately-held biopharmaceutical company focused on the discovery and development of first-in-class chronic therapies addressing complications of renal disease, announced today that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application to initiate clinical studies for its lead program TRC101.
At the same time, the company is building out its leadership team with key regulatory and administrative hires. Claire Lockey was appointed to the position of Chief Development Officer and Senior Vice President, where she will oversee Tricida’s regulatory affairs, quality assurance, and project management. Edward J. Hejlek, J.D., joined Tricida as General Counsel and Senior Vice President, where he will be responsible for overseeing corporate, intellectual property and transactional legal activities on behalf of the company.
“With the FDA’s acceptance of our IND for our lead candidate, TRC101, Tricida is on track to start its first clinical trial in chronic kidney disease patients in the first half of this year,” stated Gerrit Klaerner, Ph.D., Tricida’s CEO and President. “Furthermore, we are tremendously pleased to welcome Claire and Ed to Tricida at this exciting time for the company. Claire’s extensive regulatory and development experience will be an invaluable asset to Tricida as we kick-off our clinical program, and Ed’s impressive track record on pharmaceutical and biotech intellectual property issues will ensure that we have a strong patent portfolio for Tricida’s first-in-class treatment.”
Ms. Lockey joins Tricida from Relypsa, Inc., where she led the regulatory efforts leading to FDA approval of Relypsa’s novel hyperkalemia treatment VeltassaTM (patiromer). “I look forward to being part of Tricida’s continued success and helping to bring to patients another important treatment in an area of significant unmet medical need for renal disease patients,” said Claire Lockey. Prior to Relypsa, Ms. Lockey served as Vice President, Regulatory Affairs at FibroGen, Inc., where she oversaw multiple product candidates and managed all of FibroGen’s regulatory submissions, quality assurance and compliance activities.
Mr. Hejlek was most recently a partner in the St. Louis and San Francisco offices of the national law firm Bryan Cave LLP, and before that practiced at the St. Louis firm Senniger Powers LLP. Mr. Hejlek served as outside patent counsel for Ilypsa, and also oversaw the successful prosecution and licensing of the famous Taxol anti-cancer drug process patents. “I am excited to join Tricida to continue building the strong intellectual property portfolio and ensure that all corporate activities keep up with the rapid development of TRC101,” stated Edward Hejlek.
About Tricida, Inc.
Tricida, Inc., is a development-stage biopharmaceutical company focused on the discovery and development of first-in-class therapeutics. Tricida’s lead program is TRC101, a chronic treatment for complications of renal disease. More information is available at www.tricida.com.