Pfiz­er puts the pres­sure on Eli Lil­ly's JAK in­hibitor Olu­mi­ant with new da­ta in alope­cia area­ta

As Eli Lil­ly looks to se­cure a win for its block­buster Olu­mi­ant in alope­cia area­ta, go­ing where no JAK in­hibitor has gone be­fore, Pfiz­er is com­ing up from be­hind with Phase IIb/III re­sults sug­gest­ing its own can­di­date can help re­grow hair lost due to the au­toim­mune dis­ease.

On Wednes­day, Pfiz­er un­veiled topline re­sults from the AL­LE­GRO tri­al, which en­rolled 718 pa­tients 12 years and old­er with alope­cia area­ta, a con­di­tion that can cause sud­den, se­vere and patchy hair loss. While the pa­tients’ episodes of alope­cia area­ta var­ied in length, they all had one thing in com­mon: They had lost at least half the hair on their scalps.

The par­tic­i­pants re­ceived vary­ing dos­es of Pfiz­er’s JAK in­hibitor ritlecitinib — 50 mg or 30 mg (with or with­out one month of ini­tial treat­ment with once-dai­ly 200 mg dos­es of ritlecitinib), or 10 mg — or a place­bo.

Af­ter six months, a sig­nif­i­cant­ly larg­er pro­por­tion of pa­tients in the 50 mg and 30 mg dose groups (with or with­out the ini­tial treat­ment) were miss­ing on­ly 20% of their hair or less, com­pared to place­bo, ac­cord­ing to Pfiz­er. The com­pa­ny didn’t re­lease any hard num­bers, but says it’s div­ing right in­to a 24-week ex­ten­sion study.

“We are pleased by these pos­i­tive re­sults for ritlecitinib in pa­tients with alope­cia area­ta, a dev­as­tat­ing and com­plex au­toim­mune dis­ease for which there are cur­rent­ly no U.S. Food and Drug Ad­min­is­tra­tion (FDA) or Eu­ro­pean Med­i­cines Agency ap­proved treat­ments,” Michael Cor­bo, chief de­vel­op­ment of­fi­cer of in­flam­ma­tion and im­munol­o­gy in Pfiz­er’s glob­al prod­uct de­vel­op­ment unit, said in a state­ment.

Michael Cor­bo

Back in April, Eli Lil­ly re­port­ed that 35% of the sub­jects who re­ceived 4 mg dos­es of baric­i­tinib achieved 80% or more scalp hair cov­er­age, ver­sus 22% in the 2 mg arm. At the time, the com­pa­ny said it was shoot­ing to file an NDA in the sec­ond half of this year.

The FDA has be­come in­creas­ing­ly skep­ti­cal of JAK in­hibitors since first ap­prov­ing Pfiz­er’s Xel­janz in 2012, re­cent­ly de­lay­ing de­ci­sions for a slate of sup­ple­men­tal NDAs to get a clos­er look at safe­ty da­ta, in­clud­ing Olu­mi­ant and Ab­b­Vie’s Rin­voq in atopic der­mati­tis. Last sum­mer, the agency turned down Gilead’s rheuma­toid arthri­tis can­di­date fil­go­tinib, de­mand­ing to see more safe­ty da­ta. And ear­li­er this year, Xel­janz failed a six-year safe­ty study, show­ing that pa­tients who took the drug ex­pe­ri­enced more car­dio­vas­cu­lar events and high­er rates of can­cer than those who took Hu­mi­ra or En­brel.

Ritlecitinib’s safe­ty pro­file was con­sis­tent with pre­vi­ous stud­ies, Pfiz­er said, not­ing that the oc­cur­rence of side ef­fects was sim­i­lar across all treat­ment groups. The most com­mon ones were colds, headaches, and up­per res­pi­ra­to­ry tract in­fec­tions. There were no ma­jor ad­verse car­diac events or deaths in the tri­al, ac­cord­ing to the phar­ma com­pa­ny. How­ev­er, two pa­tients in the 50 mg group dis­con­tin­ued the study due to breast can­cer, and one pa­tient in the same group de­vel­oped a pul­monary em­bolism.

Pfiz­er and Eli Lil­ly aren’t the on­ly two drug­mak­ers duk­ing it out for an in­di­ca­tion in alope­cia area­ta. Con­cert Phar­ma­ceu­ti­cals snagged a break­through des­ig­na­tion for its JAK in­hibitor last sum­mer, and launched a sec­ond Phase III tri­al in May. Back in 2018, Aclaris Ther­a­peu­tics failed a Phase II study with an alope­cia area­ta can­di­date it li­censed from Rigel Phar­ma, find­ing that the mol­e­cule didn’t im­prove scalp hair cov­er­age com­pared to place­bo. That can­di­date is no longer in the com­pa­ny’s pipeline.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.

The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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