FDA places clinical hold on Idenix Pharmaceuticals’ hepatitis C drug IDX19368

Idenix Pharmaceuticals' shares fell as much as 12 percent on Monday on news that the FDA placed a clinical hold on its hepatitis C compound IDX19368 due to cardiac-related concerns about Bristol-Myers Squibb's BMS-986094, which belongs to the same nucleotide polymerase inhibitor drug class. The company also said the FDA had requested additional cardiac testing of patients in an ongoing Phase IIb trial of its other hepatitis C treatment, IDX184, as part of a recent partial clinical hold on the compound stemming from the BMS-986094 concerns, and that it expects to submit the data in the coming weeks.

CEO Ron Renaud stated that "based on our discussions with the FDA, we understand the clinical hold [on IDX19368] is a precautionary decision." Idenix confirmed that no patients were exposed to IDX19368 thus far. Last week, Bristol-Myers Squibb reported that it would halt development of its therapy after one patient died and eight others were hospitalised in clinical trials.

Renaud explained that while "both IDX184 and IDX19368 fall into the same broader class of NS5B inhibitors, and share the same active metabolite as BMS-986094,…there are many attributes of our compounds, particularly the prodrug approach, that we believe favourably differentiate the toxicity profiles" from BMS-986094. He added that Bristol-Myers Squibb "agreed to share relevant information on BMS-986094 with us and hope this helps us to resolve this issue quickly."

Commenting on the news, Brean Murray Carret & Co. analyst Brian Skorney remarked, "I don’t think it takes both Idenix drugs off the table, but it does slow them down."

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