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)

Among a positively jam-packed multiple sclerosis market, Roche’s Ocrevus has managed to stand out for what the Swiss drugmaker is calling the most successful launch in its long history. But in order to press its advantage, Ocrevus is looking to earlier-stage patients, and new interim data should help build its case there.

After 48 weeks on Roche’s Ocrevus, 85% of newly diagnosed primary progressing or relapsing MS patients without a history of disease modifying therapy posted no disease activity, including disease progression or relapse, according to interim data set to be presented this weekend at the virtual American Academy of Neurology meeting.