September 27, 2018
HighTide Therapeutics Inc., a globally focused clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with primary sclerosing cholangitis (PSC).
“We believe this may be the first Fast Track Designation granted by FDA for this rare liver disease, reflecting the recognition by the FDA that HTD1801 has the potential to address a significant unmet medical need in patients with this serious condition,” said Janice Soreth, M.D., Chief Strategy and Regulatory Officer of HighTide.
Liping Liu, PhD, Chief Executive Officer of HighTide, commented, “Currently, there are no FDA-approved therapies for the treatment of PSC. We are eager to work closely with the FDA to advance the development of HTD1801. We believe that HTD1801 holds the promise of addressing this complex and debilitating disease in a comprehensive manner.”
FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An investigational drug that receives Fast Track Designation is eligible for more frequent communications between the FDA and the company relating to the development plan and clinical trial design, and may be eligible for priority review if certain criteria are met.
HighTide completed a first in human study of HTD1801 in healthy volunteers. A multi-center Phase 2 trial in adult patients with PSC is currently enrolling in the United States.
About HighTide Therapeutics and HTD1801
HighTide Therapeutics Inc., founded in 2011 in Shenzhen, China, is dedicated to the discovery and development of innovative therapeutics for people suffering from gastrointestinal diseases and metabolic disorders with large and unsatisfied market needs.
HTD1801 is a new molecular entity being developed for the treatment of PSC and other chronic disorders.
About Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a chronic, progressive liver disease characterized by inflammation and fibrosis of the bile ducts, leading to the formation of multifocal bile duct strictures. This cholestatic disease deteriorates to fibrosis, cirrhosis and ultimately liver failure, with an increased risk of malignancy. Currently, there are no approved therapies for PSC.
Steven E. Linberg, PhD