In a sur­prise set­back, Mer­ck has slammed the brakes on the de­vel­op­ment of an ex­per­i­men­tal HIV drug — in­clud­ing a Phase II tri­al — af­ter in­ves­ti­ga­tors flagged a drop in im­mune cell counts that an ex­ter­nal com­mit­tee de­ter­mined was re­lat­ed to treat­ment.

The Phase II study that first sound­ed the alarm, dubbed IMAG­INE-DR, was test­ing the once-week­ly com­bi­na­tion of MK-8507 (a non-nu­cle­o­side re­verse tran­scrip­tase in­hibitor) and is­la­travir, or ISL, a nu­cle­o­side re­verse tran­scrip­tase translo­ca­tion in­hibitor.

Where­as Mer­ck is paus­ing all pro­grams in­volv­ing MK-8507, the com­pa­ny says it “re­mains con­fi­dent in is­la­travir’s over­all pro­file” and will car­ry on with it.

For Mizuho an­a­lyst Mara Gold­stein, that of­fers a glass half full sit­u­a­tion.

“MRK’s lead an­ti-HIV can­di­date is is­la­travir (ISL), which we see as undis­turbed at this point,” she wrote. “Based on a larg­er body of clin­i­cal da­ta for ISL’s an­ti-HIV ef­fi­ca­cy in­clud­ing the re­cent pos­i­tive top-line up­date (see NOTE), we are not fore­cast­ing changes in the broad­er ISL-based HIV stud­ies, and our mod­el re­mains the same.”

Is­la­travir is al­so one of the two cen­ter­pieces of Mer­ck and Gilead’s joint ef­fort to de­vel­op a long-act­ing HIV ther­a­py, along­side Gilead’s cap­sid in­hibitor lenaca­pavir.

Joan But­ter­ton

Joan But­ter­ton, VP of in­fec­tious dis­eases glob­al clin­i­cal de­vel­op­ment at Mer­ck Re­search Lab­o­ra­to­ries, not­ed Mer­ck re­mains “res­olute” in its pledge to help end the HIV pan­dem­ic and high­light­ed that all clin­i­cal stud­ies pro­vide im­por­tant “learn­ings.”

In IMAG­INE-DR, study par­tic­i­pants ran­dom­ized to re­ceive ISL+MK-8507 saw a de­crease in to­tal lym­pho­cyte and CD4+ T cell counts. The great­est drops were ob­served in the arms of the study re­ceiv­ing the high­est dos­es of MK-8507, name­ly 200 mg and 400 mg.

The ex­ter­nal da­ta mon­i­tor­ing com­mit­tee con­clud­ed that the ad­verse ef­fect had to do with the treat­ment and rec­om­mend­ed stop­ping the tri­al. Mer­ck oblig­ed, and re­viewed all of its tri­als in­volv­ing ISL with a spe­cial eye to those met­rics.

Here’s what they found:

• The on­go­ing Phase II tri­al (MK-8591-016) is eval­u­at­ing month­ly ISL for PrEP in par­tic­i­pants with low risk of HIV-1 in­fec­tion. Among this un­in­fect­ed group, there was a dose-de­pen­dent de­crease in lym­pho­cyte counts but mean de­creas­es were in the nor­mal range, and there was no in­crease in clin­i­cal ad­verse events re­lat­ed to in­fec­tion.
• IL­LU­MI­NATE SWITCH A and IL­LU­MI­NATE SWITCH B (MK-8591A-017 and MK-8591A-018) are two Phase III tri­als eval­u­at­ing do­ravirine in com­bi­na­tion with ISL dai­ly (DOR/ISL) in HIV-1 vi­ro­log­i­cal­ly sup­pressed par­tic­i­pants. Here, Mer­ck found a small, treat­ment re­lat­ed mean de­crease in CD4+ T cell counts through week 48, but no in­creased in­ci­dence of AEs re­lat­ed to in­fec­tion.

Mer­ck re­cent­ly re­port­ed pos­i­tive da­ta from the IL­LU­MI­NATE stud­ies, sug­gest­ing the DOR/ISL com­bo has com­pa­ra­ble ef­fi­ca­cy as ex­ist­ing an­ti­retro­vi­ral ther­a­pies.

“In­ves­ti­ga­tors for these tri­als have been in­formed and the tri­als are con­tin­u­ing,” the com­pa­ny wrote.

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.