Bengaluru: Rezolute Inc said on Monday the U.S. Food and Drug Administration had lifted its partial clinical hold on a late-stage study testing the company’s treatment for low blood sugar, sending its shares up 10.3% in early trading.
The hold was placed last year due to historical data that reflected liver toxicity in lab rats following the company’s therapy, ersodetug.
The health regulator also imposed a minimum age restriction of 12 years for U.S. patients and dose level restrictions for studies involving ersodetug.
The FDA concluded that the liver toxicity observed was likely specific to a particular type of rats called Sprague Dawley, and not otherwise relevant to humans, Rezolute CEO Nevan Elam said in a statement on Monday.
Sprague Dawley rats are commonly used in research studies.
The company had in May completed a toxicology study in lab rats that showed that there were no observed liver abnormalities.
Rezolute now anticipates potential U.S. enrollment for the study to begin in early 2025, and expects to announce results in the second half of 2025.
Ersodetug, the company’s only drug candidate in late-stage trials, is being tested outside the U.S. in participants with congenital hyperinsulinism, a genetic disorder that causes low blood sugar.
The study is enrolling up to 56 participants in more than a dozen countries, with eligibility ranging from three months to 45 years of age, the company said.
(Reporting by Sneha S K in Bengaluru; Editing by Vijay Kishore and Sriraj Kalluvila)
