Cor­bus brags about an­oth­er PhII suc­cess for its lead drug, but shares slide ear­ly

Yu­val Co­hen, Cor­bus CEO

Cor­bus Phar­ma­ceu­ti­cals has plucked out some pos­i­tive da­ta from its mid-stage cys­tic fi­bro­sis study. But it didn’t help its stock price this morn­ing.

While the Phase II goal for its add-on drug an­aba­sum (JBT-101 or Re­sunab) was safe­ty and tol­er­a­bil­i­ty — which the biotech says they hit — it was an ef­fi­ca­cy sig­nal they picked up in a high-dose group that drew most of the at­ten­tion. There, the com­pa­ny says, a twice dai­ly 20 mg dose of the drug trig­gered a 75% re­duc­tion in the an­nu­al­ized rate of pul­monary ex­ac­er­ba­tions re­quir­ing IV an­tibi­otics com­pared to place­bo co­hort.

While Cor­bus tout­ed the da­ta as an­oth­er sign of clin­i­cal progress, there was con­sid­er­able chat­ter on Twit­ter at­tack­ing the re­sults, which ex­plains why shares are down 13% in pre-mar­ket trad­ing.

TheStreet’s Adam Feuer­stein, a fre­quent crit­ic of Cor­bus, launched a full scale as­sault on the com­pa­ny, say­ing the da­ta shows no signs of a clin­i­cal ben­e­fit and that re­searchers just got lucky on pul­monary ex­ac­er­ba­tions with a hand­ful of cas­es to com­pare.

In this four-month study of cys­tic fi­bro­sis pa­tients, the Cor­bus drug failed to im­prove lung func­tion com­pared to a place­bo. Over­all res­pi­ra­to­ry symp­toms, mea­sured by a cys­tic fi­bro­sis pa­tient ques­tion­naire, al­so showed no dif­fer­ence be­tween an­aba­sum and place­bo.

Cor­bus CEO Yu­val Co­hen re­spond­ed:

We don’t com­ment on stock move­ments but it is note­wor­thy that there is a siz­able short po­si­tion in our stock that is prob­a­bly hav­ing a bad hair day this morn­ing…

There were a to­tal of 85 pa­tients re­cruit­ed for this study, and the high dose was test­ed in the sec­ond part of the Phase II, weeks 5 through 12, with 30 pa­tients get­ting a 20 mg sin­gle dose per day and 31 get­ting the twice dai­ly dose. Eleven pa­tients in the place­bo arm were as­signed to the drug groups and 24 pa­tients con­tin­ued on place­bo.

Five pa­tients with­drew due to ad­verse events — five on place­bo, three on an­aba­sum. And the re­searchers al­so high­light­ed some pos­i­tive bio­mark­er re­sults as well.

The lat­est batch of mid-stage da­ta fol­lows an­oth­er small Phase II for sys­temic scle­ro­sis, an au­toim­mune dis­ease of con­nec­tive tis­sue, that helped add some pos­i­tive at­ten­tion for the com­pa­ny, which has been un­der an in­tense short at­tack. Us­ing a com­pos­ite score to gauge a re­sponse on a slate of key mea­sures like lung func­tion, the com­bined drug arm in­clud­ing pa­tients on a range of dos­es of re­sunab (JBT-101) post­ed a me­di­an 33% CRISS score af­ter 16 weeks of ther­a­py, com­pared to 0% in the place­bo group. And that marks a sig­nif­i­cant ben­e­fit for pa­tients, says the biotech, with a p-val­ue of 0.044 — not a great num­ber, but with­in the mar­gin need­ed to de­clare a win.

These small stud­ies and sub­group analy­ses leave a lot to be de­sired, but Cor­bus CEO Co­hen — nev­er re­luc­tant to boast about suc­cess­es — be­lieve it helps show that the com­pa­ny is on track to de­liv­er in piv­otal stud­ies.

“The re­duc­tion in acute pul­monary ex­ac­er­ba­tions along with re­duc­tions in in­flam­ma­to­ry cells and in­flam­ma­to­ry me­di­a­tors in spu­tum demon­strate the po­ten­tial for an­aba­sum as a new in­flam­ma­tion-tar­get­ing ther­a­peu­tic in cys­tic fi­bro­sis that can broad­ly tar­get pa­tients with­out re­gard to their spe­cif­ic CFTR mu­ta­tions. The out­comes of this 16-week study in­di­cate that an­aba­sum has the po­ten­tial to ad­dress the im­por­tant un­met need for treat­ments that tar­get in­flam­ma­tion in CF,” com­ment­ed prin­ci­pal in­ves­ti­ga­tor James Chmiel.

Most of these pa­tients were al­ready tak­ing Orkam­bi, a com­bo drug from Ver­tex which has proved to have a mod­est but ef­fec­tive im­pact on CF.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

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