Block­buster per­for­mance: Re­gen­eron, Sanofi add stel­lar PhI­II dupilum­ab da­ta on dis­play at EADV

Af­ter a steady drum­beat of praise from Re­gen­eron and its part­ners at Sanofi, in­ves­ti­ga­tors to­day backed up their un­blush­ing op­ti­mism over their late-stage drug prospect dupilum­ab with a batch of stel­lar late-stage tri­al da­ta for atopic der­mati­tis, adding to the pos­i­tive pro­file al­ready sketched out.

The sci­en­tists turned up at the Eu­ro­pean Acad­e­my of Der­ma­tol­ogy and Venere­ol­o­gy in Vi­en­na to re­view the da­ta from SO­LO1 and SO­LO2. And it was worth the wait for a drug they plan to mar­ket as Dupix­ent as they look to start rack­ing up rev­enue against the multi­bil­lion-dol­lar peak sales es­ti­mates that have hov­ered around this drug.

On every ma­jor score, dupilum­ab hand­i­ly out­per­formed the place­bo, un­der­scor­ing the part­ners’ high ex­pec­ta­tions for a ther­a­py that’s al­so in late-stage test­ing for asth­ma. And new da­ta on itch­ing and de­pres­sion should help close the sale.

Gi­an­lu­ca Pirozzi

“I tru­ly be­lieve this is go­ing to be rev­o­lu­tion­ary for many pa­tients,” Gi­an­lu­ca Pirozzi, the glob­al project head for Sanofi, tells me. This is the first mon­o­clon­al an­ti­body that blocks both Il-4 and IL-13 cy­tokines, and there’s noth­ing that looks like a ri­val threat on the near hori­zon, leav­ing these two big play­ers a lot of room to move.

The pa­tients in these sto­ries rep­re­sent a se­vere­ly af­flict­ed group, he adds, with no chance of re­lief. And while a long way from a uni­ver­sal ef­fect, the da­ta in­di­cate that this drug has a tremen­dous amount of com­mer­cial po­ten­tial, with lit­tle in the way of safe­ty is­sues to fret about.

The full re­port card now in­cludes:

On the Pru­ri­tus NRS ranges from 0 (no itch) to 10 (worst itch imag­in­able). At 16 weeks, for SO­LO 1 and SO­LO 2, re­spec­tive­ly, 41 and 36 per­cent of pa­tients who re­ceived Dupix­ent 300 mg every two weeks, and 40 and 39 per­cent of pa­tients who re­ceived Dupix­ent 300 mg week­ly, achieved a four-point or greater re­duc­tion in their NRS score com­pared to 12 and 10 per­cent with place­bo.

Lest any­one for­get, the two big part­ners have al­so post­ed an im­pres­sive amount of pos­i­tive da­ta.

On the pri­ma­ry end­point: 37 and 36 per­cent of adult pa­tients who re­ceived Dupix­ent 300 mg week­ly, and 38 and 36 per­cent of pa­tients who re­ceived Dupix­ent 300 mg every two weeks, achieved clear­ing or near-clear­ing of skin le­sions as mea­sured by the 5-point In­ves­ti­ga­tor’s Glob­al As­sess­ment (IGA) scale. In the place­bo arm, those rates were tracked at 10 and 8 per­cent with place­bo.

On an­oth­er EU pri­ma­ry and US sec­ondary end­point: 52 and 48 per­cent of adult pa­tients who re­ceived Dupix­ent 300 mg week­ly, and 51 and 44 per­cent of pa­tients who re­ceived Dupix­ent 300 mg every two weeks, achieved a 75 per­cent or greater re­duc­tion in their Eczema Area and Sever­i­ty In­dex score (EASI-75). In the place­bo arm that hit 15 and 12 per­cent.

On the per­cent im­prove­ment in EASI from base­line:  The score was 72 and 69 per­cent in pa­tients who re­ceived the 300 mg week­ly dose, and 72 and 67 per­cent for pa­tients who re­ceived Dupix­ent 300 mg every two weeks, com­pared to 38 and 31 per­cent for place­bo.

Based on the da­ta they’ve seen so far, it looks like they will go with a drug dosed once every two weeks. Dupilum­ab was re­cent­ly filed with the FDA and is get­ting a pri­or­i­ty re­view, with a PDU­FA date on March 29. So far, this drug has been sail­ing through a big Phase III with­out a hitch.

An­a­lysts haven’t over­looked the po­ten­tial here, but there has been some fret­ting that pay­ers are al­ready lay­ing in wait for a big new ther­a­py like this. And that could make it hard for these part­ners to re­al­ize the kind of big gains that have been fore­cast. Ge­of­frey Porges notes:

We now look to the part­nered com­mer­cial or­ga­ni­za­tions to ex­plain how they plan to price and pro­mote dupi, at a man­age­able ex­pense in­vest­ment, to avoid the for­mi­da­ble road­blocks that have stalled the re­cent launch­es of oth­er chron­ic use spe­cial­ty ther­a­peu­tics with large com­mer­cial op­por­tu­ni­ties. Oth­er­wise we have con­cerns that the stock is fac­ing launch es­ti­mates that are too high, and launch rev­enue that falls short of po­ten­tial.

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