Lil­ly's mirik­izum­ab, once a con­tender for pso­ri­a­sis, bol­sters case for UC in­di­ca­tion in main­te­nance tri­al da­ta read­out

Ear­ly last year, Eli Lil­ly an­nounced that in­stead of tak­ing its block­buster con­tender mirik­izum­ab for­ward to the FDA for pso­ri­a­sis, it would be es­sen­tial­ly go­ing nowhere in the in­di­ca­tion. In­stead, the phar­ma then an­nounced in its Q1 ’21 earn­ings state­ment that it would be fo­cus­ing on ul­cer­a­tive col­i­tis and Crohn’s dis­ease in­di­ca­tions in a sud­den about-face.

And as the drug is be­fore the FDA for po­ten­tial ap­proval for the first in­di­ca­tion of ul­cer­a­tive col­i­tis, the megaphar­ma is now ready to re­veal more da­ta to bol­ster its case.

Lo­tus Mall­bris

The com­pa­ny an­nounced a da­ta read­out ear­ly Tues­day morn­ing for the Lu­cent-2 study af­ter 52 weeks. While it an­nounced last De­cem­ber that both pri­ma­ry and sec­ondary end­points were met in the study, Lil­ly wait­ed un­til this week to re­lease more specifics — and the num­bers.

The tri­al, which en­rolled pa­tients with ul­cer­a­tive col­i­tis — those who had orig­i­nal­ly re­spond­ed to mirik­izum­ab in the pre­vi­ous study, a 12-week study sim­ply known as Lu­cent-1 — reached the pri­ma­ry end­point and all sec­ondary end­points in the main­te­nance tri­al.

Ac­cord­ing to Lil­ly, the pri­ma­ry end­point was clin­i­cal re­mis­sion, with just shy of 50% of par­tic­i­pants in the mirik­izum­ab arm reach­ing the goal com­pared to 25% on place­bo. Clock­ing in a p-val­ue of un­der 0.001, 182 of 365 pa­tients in the mirik­izum­ab arm reached the pri­ma­ry end­point com­pared to on­ly 45 of the 179 pa­tients in place­bo. For those who had al­ready reached clin­i­cal re­mis­sion by week 12, 63% — or 91 out of 143 in the treat­ment arm — main­tained clin­i­cal re­mis­sion through the rest of the tri­al.

Lil­ly not­ed that all but four pa­tients who achieved re­mis­sion af­ter one year were no longer tak­ing cor­ti­cos­teroids for at least three months pri­or to the end of main­te­nance treat­ment. Cor­ti­cos­teroids have been used as a com­mon short-term treat­ment for ul­cer­a­tive col­i­tis be­cause of its abil­i­ty to re­duce in­flam­ma­tion.

For sec­ondary end­points, bow­el ur­gency sever­i­ty was one of the more no­table ones, Lil­ly’s VP of glob­al im­munol­o­gy de­vel­op­ment and med­ical af­fairs Lo­tus Mall­bris told End­points News. One of the tri­al in­ves­ti­ga­tors, Mar­la Du­bin­sky from the Ic­ahn School of Med­i­cine at Mount Sinai, said in a state­ment that 40% of mirik­izum­ab pa­tients achieved res­o­lu­tion or near res­o­lu­tion of their symp­tom of bow­el ur­gency.

“We did an­oth­er study that showed the high­est symp­tom that both­ers pa­tients is bow­el ur­gency,” Mall­bris said. As part of the Lu­cent-2 study, pa­tients were di­rect­ed to a 11-point scale — rang­ing from 0 to 10, high­er be­ing more se­vere — to as­sess changes in the sever­i­ty of their bow­el ur­gency symp­toms. And ac­cord­ing to the da­ta:

  • Among pa­tients who achieved clin­i­cal re­sponse in the 12-week in­duc­tion study and who had a base­line ur­gency sever­i­ty of 3 or greater, 42.9% of par­tic­i­pants on mirik­izum­ab (144 out of 336) achieved res­o­lu­tion or near res­o­lu­tion of bow­el ur­gency sever­i­ty at one year com­pared to one in four on place­bo — al­so scor­ing a p-val­ue of un­der 0.001.

  • Among pa­tients who achieved clin­i­cal re­sponse in the 12-week in­duc­tion study, pa­tients re­ceiv­ing mirik­izum­ab had a sta­tis­ti­cal­ly sig­nif­i­cant av­er­age re­duc­tion in bow­el ur­gency sever­i­ty of 3.80 points — be­tween 3.53 and 4.07 at one year, com­pared to 2.74 (2.35 to 3.14) points for pa­tients on place­bo, with the same p-val­ue of un­der 0.001.

The drug is a new­er type of ther­a­py — still part of the fam­i­ly of IL-23 in­hibitors, but go­ing af­ter a sub­type of IL-23: IL-23p19. Oth­er al­ready-ap­proved IL-23 in­hibitors would be IL-23p40 in­hibitors. While oth­er drugs have been al­ready ap­proved for ul­cer­a­tive col­i­tis such as Zeposia from Bris­tol My­ers Squibb, it would be a new mech­a­nism of ac­tion akin to the al­ready-ap­proved Skyrizi, the Ab­b­Vie-Boehringer In­gel­heim drug that is still wait­ing for an ul­cer­a­tive col­i­tis ap­proval. As of Feb­ru­ary, the FDA ex­tend­ed Skyrizi’s PDU­FA date for Crohn’s dis­ease by three months in or­der to re­view ad­di­tion­al da­ta.

As for what’s next for Eli Lil­ly, the phar­ma had al­ready sub­mit­ted a BLA for the drug can­di­date back in Q1 with the FDA — and al­so an MAA with the EMA. These new da­ta have al­ready been sent to the reg­u­la­to­ry agen­cies in ques­tion, Mall­bris said. And for right now, Lil­ly is ex­pect­ing an an­swer from those agen­cies some­time next year.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of pharma environmental, social and governance (ESG) efforts in the past two years has been meteoric as investors turn their attention to sustainable funding. However, investors aren’t the only ones watching. Patients are beginning to tune into pharmas’ ESG promises too.

Patient advocacy groups familiar with ESG regard it as an important issue and want to be included in helping pharma companies set ESG policies and targets, according to a new report from PatientView. That’s quite different from what the investment community wants across a variety of Gartner’s defined financial, competitive, strategic and perception goals.