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HighTide receives FDA fast track designation for PSC therapy

HighTide Therapeutics received an FDA fast track designation for HTD1801, a new molecular entity in development for the treatment of primary sclerosing cholangitis and other chronic disorders, according to a press release.

“Currently, there are no FDA-approved therapies for the treatment of PSC,” Liping Liu, PhD, CEO of HighTide, said in the release. “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.”

HighTide recently completed a phase 1 trial of HTD1801 in healthy volunteers. The company is currently enrolling adult patients with PSC in a multi-center trial in the U.S.

“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,” Janice Soreth, MD, chief strategy and regulatory officer of HighTide, said in the release.

Reference: www.hightidebio.com