March 31, 2022
SHENZHEN, CHINA and ROCKVILLE, MD, March 31, 2022 — HighTide Therapeutics, Inc. (“HighTide”), a global, clinical-stage biopharmaceutical company leading the discovery and development of multi-functional drugs with synergistic effects to treat metabolic and digestive diseases, today announced the appointment of Myleen Leoncavallo as Senior Vice President of Regulatory Affairs and Quality Assurance.
Mrs. Leoncavallo has over 25 years of experience in drug development and regulatory affairs including the filing of 4 New Drug Applications, 2 Biologics License Applications, 5 Marketing Authorization Applications, 2 New Drug Submissions, 18 Investigational New Drug Applications and 14 Clinical Trial Applications.
Most recently she served as Vice President, Head of Global Regulatory Affairs at Mirum Pharmaceuticals, Inc., where she established their global regulatory function and played a key role in securing approval of LIVMARLI® for the treatment of cholestatic pruritus in Alagille syndrome, and also provided regulatory strategic leadership for the global development of maralixibat for progressive familial intrahepatic cholestasis and biliary atresia, as well as Mirum’s earlier stage program, volixibat, in primary sclerosing cholangitis, intrahepatic cholestasis of pregnancy, and primary biliary cholangitis. Mrs. Leoncavallo will report to Dr. Leigh MacConell, Chief Development Officer of HighTide.
“We are very pleased to welcome Myleen to HighTide,” said Liping Liu, Ph.D., Chief Executive Officer of HighTide. “Her successful track record in global regulatory affairs and specific experience with rare liver diseases will greatly enhance HighTide’s ability to advance and expand our pipeline for patients with unmet needs.”
Prior to Mirum, Mrs. Leoncavallo served in several senior regulatory affairs roles, including positions at Ultragenyx Pharmaceuticals and BioMarin Pharmaceuticals, biopharmaceutical companies focused on rare diseases. Mrs. Leoncavallo holds a Bachelor of Science degree in Biochemistry and Cell Biology and a Bachelor of Arts degree in English from the University of California, San Diego and Master of Science degrees in both Regulatory Science and Pharmaceutical Chemistry from the University of Southern California in Los Angeles.
HighTide is a global clinical-stage biopharmaceutical company focused on discovering and developing novel drugs to treat metabolic and digestive diseases with significant unmet medical needs. The company’s lead drug candidate, HTD1801, has the potential to become a first-in-indication drug for primary sclerosing cholangitis and first-in-class treatment for primary biliary cholangitis, nonalcoholic steatohepatitis+type 2 diabetes mellitus (T2DM)/pre-T2DM, T2DM+nonalcoholic fatty liver diease and hypertriglyceridemia.
For additional information, please visit https://hightidetx.com.