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)

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.