FDA fast-tracks HTD1801 for clinical trials

This is also fairly interesting and positive news from FDA.

HighTide receives FDA fast track designation for PSC therapy
“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.”

Direct links to HTD1801 clinical trials:

“104 participants…A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)”

“Phase2…90 participants…
A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)
A primary parallel group comparison for a 6-week treatment, followed by a 6-week dose-controlled extension, and followed by a 6-week random withdrawal.”