Hanall Biopharma shares are recovering gradually in Thursday morning session from a 24 percent crash in the previous day when its American partners Immunovant announced a voluntary pause of dosing in its ongoing clinical trials of investigational drug IMVT-1401 for the treatment of thyroid eye disease (TED).
Immunovant picked up the drug from the Korean biotech firm in December 2017 in a $500-million deal, and Hanall Biopharma is a license holder for the drug in Asia and Oceania only.
On Thursday, Hanall Biopharma shares added 3.68 percent to close at 25,350 won ($22.66). Immunovant has bet on its single-asset pipeline after promising data of IMVT-1401.
The announcement came after the Nasdaq-listed company found elevations in total cholesterol and LDL levels in IMVT-1401-treated patients in a Phase 2b trial. Cholesterol levels were not measured in prior clinical trials.
The randomized, placebo-controlled trial in TED was designed to evaluate the safety and efficacy of 680mg and 340mg doses, each given weekly for 12 weeks. Based on preliminary data from some 40 patients, mean LDL cholesterol level at week 12 was increased by about 65 percent in the 680mg dose group, and by 40 percent in the 340mg dose group, but did not increase in the control group.
Immunovant said it will work closely with regulators and experts to characterize the detailed profile of the lipid changes and to understand the mechanism of those changes. It plans to continue clinical development of IMVT-1401 after discussion and agreement with regulators regarding its protocol modifications.
By Kim Byung-ho and Minu Kim
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