Ab­b­Vie adds more stel­lar da­ta on ABT-494 — this time for atopic der­mati­tis

Michael Sev­eri­no

ABT-494 has de­liv­ered stel­lar re­sults in a Phase IIb study for atopic der­mati­tis, scor­ing a big win for Ab­b­Vie $AB­BV on a drug it counts as one of its most ex­cit­ing late-stage block­buster prospects.

The drug, AKA upadac­i­tinib, hand­i­ly whipped a place­bo group among treat­ment re­sis­tant pa­tients, with a 74% im­prove­ment in a key mea­sure of dis­ease sever­i­ty for the group tak­ing the high dose of their JAK1 drug. Up to 69% of the pa­tients tak­ing one of three dos­es achieved a 75% im­prove­ment.

Here’s the score on itch­ing:

Pa­tients treat­ed with upadac­i­tinib ex­pe­ri­enced 69/48/40 per­cent im­prove­ment in itch across the 30/15/7.5 mg upadac­i­tinib dos­es, as mea­sured by the pru­ri­tus nu­mer­i­cal rat­ing scale (NRS), com­pared to 10 per­cent for pa­tients re­ceiv­ing place­bo (p<0.001/0.001/0.01, re­spec­tive­ly).

Those kind of da­ta bode well for Ab­b­Vie, which is look­ing to tack­le a field that is go­ing through an up­heaval spurred by new drugs like Dupix­ent. Ab­b­Vie chose to walk away from some big part­ner­ships to fo­cus on its in-house drug, con­vinced that they were on to a win­ner. And these num­bers look bet­ter than Dupix­ent’s.

Just a few months ago Ab­b­Vie re­port­ed great re­sults from its first late-stage rheuma­toid arthri­tis study us­ing ABT-494.

“We are ex­cit­ed by the re­sults of this study, which show that upadac­i­tinib has the po­ten­tial to be an im­por­tant treat­ment op­tion for pa­tients with atopic der­mati­tis,” said Michael Sev­eri­no, ex­ec­u­tive vice pres­i­dent, re­search and de­vel­op­ment and chief sci­en­tif­ic of­fi­cer, Ab­b­Vie. “We look for­ward to ad­vanc­ing upadac­i­tinib to Phase 3 stud­ies in 2018. Ab­b­Vie’s con­tin­ued progress across our upadac­i­tinib clin­i­cal de­vel­op­ment pro­gram fur­ther demon­strates that se­lec­tive in­hi­bi­tion of the JAK1 path­way may be a nov­el ther­a­peu­tic ap­proach across a broad range of im­mune-me­di­at­ed dis­eases.”

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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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

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.

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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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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