Lit­tle Leo Phar­ma en­ters the prize-fight ring with pos­i­tive PhI­II atopic der­mati­tis da­ta. Now they just have to beat Dupix­ent

A day af­ter new Sanofi CEO Paul Hud­son staked his rep­u­ta­tion and the fu­ture of the phar­ma gi­ant on mak­ing Dupix­ent a mega­suc­cess sto­ry, lit­tle Leo Phar­ma is throw­ing down the gaunt­let on atopic der­mati­tis.

Three years ago Leo paid As­traZeneca $115 mil­lion to buy up rights to use tralok­inum­ab against atopic der­mati­tis — with $1 bil­lion more on the ta­ble in mile­stones — the Dan­ish com­pa­ny says their drug has swept up pos­i­tive re­sults for all pri­ma­ry and sec­ondary end­points in three Phase III tri­als. Now they plan to start the fi­nal push for reg­u­la­to­ry ap­provals so they can chal­lenge the heavy­weight cham­pi­ons in this slugfest.

To put it mild­ly, it’s not go­ing to be easy — un­der the best of cir­cum­stances.

At the time As­traZeneca did the deal with Leo, they were busy find­ing as­sets to auc­tion off as Pas­cal So­ri­ot looked to soft­en the ug­ly fi­nan­cial blows they were tak­ing as rev­enue slid steadi­ly down­ward. As­traZeneca — which over the last year has en­joyed a long-await­ed turn­around — kept their big late-stage ef­fort for tralok­inum­ab in asth­ma, con­vinced that the IL-13 drug could be a game-chang­er. In­stead, it failed in 3 straight late-stage tri­als and So­ri­ot end­ed up punt­ing it out of the pipeline.

Leo, though, nev­er veered away. To­day’s state­ment on­ly her­alds the top line re­sults, with none of the da­ta de­tails that will be cru­cial if they in­tend to be com­pet­i­tive in an in­tense­ly com­pet­i­tive field.

Ever­core ISI’s Umer Raf­fat finds the whole tralo saga in­trigu­ing, not­ing that Leo has ev­i­dent­ly been sit­ting on the re­sults for about a year. That’s not a good sign. And it left him with sev­er­al big ques­tions:

  • Why would a com­pa­ny put out first press re­lease on Ph 3s over a year af­ter they were com­plet­ed?  Not clear
  • Why didn’t Leo put out ac­tu­al ef­fi­ca­cy da­ta in to­day’s up­date?  Not clear
  • My best guess: tralo da­ta are not com­pet­i­tive.  But I can’t know for sure.

In a fol­lowup to this sto­ry, Leo’s com­mu­ni­ca­tions team got in touch to say that Raf­fat was wrong about the year-long de­lay, not­ing that the tri­als were sched­uled to wrap up in a se­ries, start­ing last Au­gust. I re­spond­ed by ask­ing when the first Phase III da­ta were ac­tu­al­ly de­liv­ered. This morn­ing, they replied — with­out an­swer­ing the ques­tion.

Be­fore is­su­ing any com­mu­ni­ca­tions on the de­vel­op­ment progress of tralok­inum­ab, it was nec­es­sary to eval­u­ate all pri­ma­ry and sec­ondary out­come mea­sures from all three piv­otal Phase 3 clin­i­cal tri­als, in ad­di­tion to ad­verse events. The full da­ta set for the blind­ed 52-week tri­als plus ad­di­tion­al weeks for safe­ty fol­low-up was not avail­able for analy­sis un­til No­vem­ber 2019.

Stan­dard op­er­at­ing pro­ce­dure in the in­dus­try is to re­port the da­ta out by tri­al as it is avail­able. The spokesper­son for the com­pa­ny, though, said Leo didn’t re­lease any hard da­ta to avoid dam­ag­ing their chances of get­ting the da­ta pub­lished in a peer-re­viewed jour­nal.

Raf­fat al­so points out there’s an­oth­er late-stage IL-13 in the AD mix: Der­mi­ra’s $DERM le­brik­izum­ab, which Roche out-li­censed af­ter they had their own failed ef­fort in asth­ma, with one suc­cess­ful Phase III and one flop.

Then there are the JAK drugs like Xel­janz, which is ap­proved for atopic der­mati­tis with a black box safe­ty warn­ing. Eli Lil­ly has been bull­ish about Olu­mi­ant, amid skep­ti­cism. Safe­ty is a con­cern with all the JAKs, which is one rea­son why the Dupix­ent group is so bull­ish about their prospects. Ab­b­Vie has Rin­voq in late-stage stud­ies, And Gilead hopes to get their break with fil­go­tinib.

More are com­ing in.

Kim Kjøller Leo

Atopic der­mati­tis is an aw­ful af­flic­tion, spurring le­sions that pro­voke a pow­er­ful urge to itch, while leav­ing a pub­lic stig­ma on ap­pear­ance. And it’s been a block­buster tar­get for a va­ri­ety of play­ers, aside from Sanofi and Re­gen­eron. Just a few days ago J&J paid $750 mil­lion for a drug called bermekimab, with plans to run it through their own piv­otal for atopic der­mati­tis and more.

In their re­lease, Leo seems to be de­ter­mined to find open­ings in the mar­ket for those who aren’t hap­py with the re­sults they’re get­ting now.

“De­spite re­cent treat­ment ad­vances, we con­sis­tent­ly hear from health­care pro­fes­sion­als around the world that ad­di­tion­al treat­ment op­tions are need­ed to ad­dress the dif­fer­ent signs and symp­toms for each pa­tient,” not­ed Kim Kjøller, the head of R&D at Leo.

Mar­ket­ing ap­pli­ca­tions are head­ed to the reg­u­la­tors ear­ly next year.

So­cial im­age: Leo Phar­ma

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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