Te­va turns the last cor­ner in the CGRP mi­graine drug race with its 2nd round of promis­ing PhI­II da­ta

Te­va has brought in its sec­ond suc­cess­ful Phase III study of its CGRP mi­graine drug fre­manezum­ab (TEV-48125), rack­ing up a fresh slate of promis­ing da­ta across all end­points that will soon be pack­aged and de­liv­ered in­to the hands of reg­u­la­tors.

Te­va re­cruit­ed a heav­i­ly af­flict­ed group of pa­tients for this episod­ic study with a mean num­ber of 9.1 mi­graine days per month go­ing in. Their $TE­VA core da­ta boils down to this: a 1.5-day ad­van­tage in re­duced mi­graine days for the drug arm, putting it in the mix of around 2 days im­prove­ment across a full slate of CGRP ri­vals test­ed in a wide va­ri­ety of mid- and late-stage stud­ies.

Umer Raf­fat at Ever­cor­eISI has been fol­low­ing the num­bers, and high­light­ed this point:

(I)n to­day’s da­ta, there is an­oth­er impt tid­bit:  Te­va prospec­tive­ly ran­dom­ized a sub­group of pa­tients in this episod­ic tri­al on sta­ble pro­phy meds … and in this sub­group, Te­va showed a 1.7-2 day stat sig mi­graine day re­duc­tion (both for quar­ter­ly and month­ly dos­es).  This may al­so help from la­bel­ing per­spec­tive.

Raf­fat de­clined to com­pare these new num­bers for episod­ic mi­graine with Am­gen or Lil­ly, not­ing the dif­fer­ence in tri­al length that makes it im­pos­si­ble to line up the stats.

The de­tails:

Fre­manezum­ab giv­en month­ly im­proved the av­er­age num­ber of mi­graine days, rel­a­tive to base­line, by 41.6% for the du­ra­tion of the tri­al (-3.7 days vs. -2.2 days for place­bo, p < 0.0001). Num­ber of days with dis­abil­i­ty were de­creased by 64.7% (p =0.0021) and med­ica­tion con­sump­tion was de­creased by 39.0%( p < 0.0001). The quar­ter­ly SC dose, which was unique­ly test­ed in this pro­gram, al­so yield­ed high­ly sig­nif­i­cant re­sults for de­crease in mi­graine days (-3.4 days or 37.0%, p < 0.0001) and for all oth­er com­par­isons. Al­so unique to this de­vel­op­ment, both dose reg­i­mens high­ly sig­nif­i­cant­ly im­proved mi­graine in sub­jects on sta­ble dos­es of oth­er pro­phy­lac­tic med­ica­tions (-4.0 days for month­ly dose vs -2.0 days for place­bo, p = 0.001; -3.7 days for quar­ter­ly dose, p = 0.006).

It all looks good enough for an ap­proval, with de­cent odds that this drug will ap­pear on the mar­ket along­side a slate of ri­vals next year. Te­va, though, is hop­ing that its month­ly and quar­ter­ly dos­ing reg­i­mens will help dif­fer­en­ti­ate it from the com­pe­ti­tion to come.

Michael Hay­den, Te­va

“Te­va’s HA­LO tri­als are the on­ly Phase III an­ti-CGRP stud­ies to demon­strate ef­fi­ca­cy with both month­ly and quar­ter­ly dos­ing for chron­ic and episod­ic pa­tients and in pa­tients al­ready re­ceiv­ing pre­ven­tion ther­a­pies. This is a ma­jor ad­vance on ex­ist­ing da­ta. The ef­fi­ca­cy and rapid on­set, as both add-on and monother­a­py, quar­ter­ly dos­ing, and ef­fect on dis­abil­i­ty and qual­i­ty of life in­di­cate that this ther­a­py has the po­ten­tial to set new and dif­fer­ent bench­marks in the re­lief of mi­graine suf­fer­ing,” said Te­va R&D chief Michael Hay­den in a state­ment. “We are im­mense­ly proud to be able to bring to the mi­graine com­mu­ni­ty the hope that they might soon have a new op­tion that could pro­vide a mean­ing­ful re­duc­tion in the mi­graine bur­den pa­tients ha­bit­u­al­ly suf­fer.”

A few weeks ago it was Eli Lil­ly’s $LLY turn to cel­e­brate its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. Lit­tle Alder $AL­DR is al­so plan­ning to wage a com­mer­cial war with their drug. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front. No­var­tis $NVS and Am­gen $AMGN — cred­it­ed as the fron­trun­ners in the race to the first OK — were the first to come up with pos­i­tive Phase III da­ta for erenum­ab (AMG 334) last fall, when a 70 mg dose scored an av­er­age 1.1 day per month drop in mi­graine episodes.

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