Eli Lilly claims success in a new JAK indication: hair loss

Jason Mast

Editor

Over the last decade, drug­mak­ers have proven JAK in­hibitors can treat a smat­ter­ing of im­mune-re­lat­ed dis­eases rang­ing from rheuma­toid arthri­tis to Covid-19. Now Eli Lil­ly has pulled out a new one.

Lil­ly and its biotech part­ner In­cyte an­nounced Wednes­day that their JAK in­hibitor baric­i­tinib ef­fec­tive­ly re­grew pa­tients’ hair in a Phase III tri­al for alope­cia area­ta, an au­toim­mune con­di­tion that can cause sud­den, se­vere and patchy hair loss. Lil­ly didn’t break down the re­sults from the 546-pa­tient tri­al, but the pri­ma­ry end­point was im­prove­ment on a stan­dard score for alope­cia symp­toms.

The FDA has be­come in­creas­ing­ly skep­ti­cal of JAK in­hibitors since they first ap­proved Pfiz­er’s Xel­janz in 2013, most re­cent­ly re­buff­ing Gilead’s fil­go­tinib and de­mand­ing to see more safe­ty da­ta. The same ques­tions have dogged baric­i­tinib and Xel­janz, which re­cent­ly failed the safe­ty study the FDA re­quired when they OK’d the drug.

Still, un­like rheuma­toid arthri­tis, where Gilead was seek­ing ap­proval, alope­cia area­ta has no ap­proved treat­ments. And Lil­ly test­ed 2mg and 4mg in the study, both low­er dos­es than the 5mg that raised the biggest con­cerns at the agency. The FDA has al­so grant­ed Lil­ly break­through des­ig­na­tion for the dis­ease, sug­gest­ing they are will­ing to work close­ly with the drug­mak­er to get it across the fin­ish line.

Lo­tus Mall­bris

The process will like­ly be­gin af­ter they will first have to prove the drug works in a sec­ond Phase III tri­al, if it con­firms the re­sults of the first Phase III. That study is due to read out in the next cou­ple months.

An ap­proval could pro­vide a path for Lil­ly to take a rare toe­hold in the JAK race. Pfiz­er has al­so stud­ied its in­hibitors in alope­cia and has re­ceived break­through des­ig­na­tion, but they re­main be­hind in de­vel­op­ment. A JAK3 in­hibitor, called ritlecitinib, is now in Phase II/III.

Lil­ly is al­so try­ing to grab the first JAK ap­proval for lu­pus, where they re­main two phas­es ahead of Mer­ck and a phase ahead of Ab­b­Vie.

“For pa­tients who suf­fer from alope­cia area­ta, it is not a cos­met­ic con­di­tion, it is a dev­as­tat­ing au­toim­mune dis­ease that can have sig­nif­i­cant psy­cho­log­i­cal ef­fects. They lose much more than just hair,” Lo­tus Mall­bris, Lil­ly’s VP of im­munol­o­gy, said in a state­ment. “We are look­ing for­ward to shar­ing the to­tal­i­ty of da­ta from the over­all clin­i­cal de­vel­op­ment pro­gram for baric­i­tinib as a po­ten­tial first-in-dis­ease treat­ment for alope­cia area­ta.”