Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

Af­ter tri­al in­ves­ti­ga­tors flagged a drop in im­mune cell counts that an ex­ter­nal com­mit­tee de­ter­mined was re­lat­ed to treat­ment last month, Mer­ck has been paus­ing HIV-re­lat­ed Phase II and III tri­als ever since.

On Mon­day, the bio­phar­ma com­pa­ny an­nounced it’s paus­ing en­roll­ment in two of its Phase III tri­als eval­u­at­ing its lead­ing an­ti-HIV drug can­di­date, which is the once-month­ly, oral is­la­travir.

“At the rec­om­men­da­tion of the ISL PrEP ex­ter­nal da­ta mon­i­tor­ing com­mit­tee (eDMC), Mer­ck is paus­ing en­roll­ment for the IM­POW­ER 22 and IM­POW­ER 24 tri­als while the com­pa­ny con­ducts fur­ther analy­ses of these and oth­er on­go­ing stud­ies,” the com­pa­ny said in a state­ment. “In­formed by the rec­om­men­da­tions of the PrEP eDMC, Mer­ck is im­ple­ment­ing ad­di­tion­al mon­i­tor­ing mea­sures for study par­tic­i­pants, in­clud­ing in­creas­ing the fre­quen­cy of to­tal lym­pho­cyte and CD4+ T-cell as­sess­ments.”

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