Cy­to­Dyn tries to squeeze pos­i­tive news out of a failed Covid-19 study — and shares take a beat­ing

Cy­to­Dyn re­al­ly, re­al­ly want­ed to put its best foot for­ward.

So much so that, af­ter sit­ting on un­blind­ed Phase IIb/III da­ta on leron­limab in Covid-19 for two weeks pend­ing reg­u­la­to­ry dis­cus­sions, the biotech is­sued six press re­leas­es over the week­end, each of­fer­ing a lit­tle more in­for­ma­tion or re­fin­ing what was pre­vi­ous­ly dis­closed.

In one of them, Cy­to­Dyn ac­knowl­edged that leron­limab — an an­ti-CCR5 an­ti­body that had al­ready been turned away at the FDA’s doorsteps once — had failed the pri­ma­ry end­point of low­er­ing all-cause mor­tal­i­ty at Day 28, as the re­sult was not sta­tis­ti­cal­ly sig­nif­i­cant. At best, ex­ecs im­plied, they would need to col­lect fur­ther clin­i­cal da­ta to be ready for reg­u­la­to­ry re­views.

Shares $CY­DY slid 20.99% to $3.20 once the stock mar­ket opened on Mon­day.

That’s not what they chose to high­light, though.

Rather, Cy­to­Dyn zoomed in on a sub­group that ac­count­ed for 62 out of 384 pa­tients en­rolled in the CD12 tri­al and de­clared a sur­vival ben­e­fit. Where­as the tri­al in­volved se­vere to crit­i­cal­ly ill pa­tients, the com­pa­ny found that me­chan­i­cal­ly ven­ti­lat­ed crit­i­cal­ly ill pa­tients saw a 24% re­duc­tion in all cause-mor­tal­i­ty be­tween the leron­limab and place­bo arms, with­out break­ing down the num­ber of deaths in ei­ther group.

Nad­er Pourhas­san

“We be­lieve these re­sults are the best re­sults ever achieved for this pop­u­la­tion in a Phase 3 clin­i­cal tri­al,” CEO Nad­er Pourhas­san boast­ed in one of the state­ments.

Fur­ther mas­sag­ing the da­ta, ex­ecs point­ed out that there were more over-65 pa­tients tak­ing leron­limab than place­bo — lead­ing them to con­duct a post hoc “age ad­just­ment” analy­sis and de­duce “(s)ta­tis­ti­cal­ly sig­nif­i­cant re­sults (p-val­ue = 0.0319)” for the pri­ma­ry end­point “in par­tic­i­pants re­ceiv­ing leron­limab + ‘com­mon­ly used COVID-19 treat­ments’ com­pared to par­tic­i­pants who re­ceived ‘com­mon­ly used COVID-19 treat­ments’ alone in the place­bo group in the over­all mod­i­fied in­tent-to-treat (‘mITT’) pop­u­la­tion.”

Not that it helped with the main out­come mea­sure:

When age ad­just­ment was con­duct­ed, the pri­ma­ry end­point was much clos­er to sta­tis­ti­cal­ly sig­nif­i­cant val­ue. Of note, the re­duc­tion of mor­tal­i­ty in this pop­u­la­tion of 65 years and younger leron­limab arm had more than 30% less mor­tal­i­ty than place­bo and 9% less mor­tal­i­ty in par­tic­i­pants over 65.

But Cy­to­Dyn claimed it’s got­ten reg­u­la­tors on board with the sub­group hy­poth­e­sis: The UK’s MHRA is ap­par­ent­ly will­ing to ac­cept da­ta from the open-la­bel ex­ten­sion of the study, which has en­rolled 45 so far. The US agency is ask­ing for da­ta from 140 more pa­tients in the crit­i­cal­ly ill pop­u­la­tion, with the new pri­ma­ry end­point of length of hos­pi­tal stay (ac­cord­ing to Cy­to­Dyn, leron­limab had short­ened time to re­cov­ery by 6 days among these pa­tients com­pared to place­bo plus stan­dard of care on­ly, with a p-val­ue of 0.005). In Cana­da, the com­pa­ny will ap­ply to start sell­ing the drug while clin­i­cal tri­als con­tin­ue — with un­clear prospects.

Some of the un­cer­tain­ty may be an­swered af­ter Cy­to­Dyn re­leas­es de­tailed re­sults on the tri­al, which it is plan­ning to do lat­er to­day. Or at the in­vestor we­b­cast sched­uled right be­fore it.

There’s just one caveat: It will be a “lis­ten on­ly” we­b­cast — in­vestors can sub­mit their ques­tions on­line.

Nad­er Pourhas­san (Pho­to by Jeff Kravitz/Film­Mag­ic for Cy­to­Dyn’s Pro)

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