Pfiz­er's JAK in­hibitor clears sec­ond piv­otal eczema study, but can it top­ple Re­gen­eron's Dupix­ent?

The atopic der­mati­tis mar­ket is crowd­ed. Dupix­ent, from Re­gen­eron and Sanofi, may be king of the ar­se­nal of ther­a­pies to com­bat eczema — but var­i­ous drug­mak­ers big and small are out to usurp its throne. Pfiz­er on Fri­day made its pitch, with a sec­ond slate of pos­i­tive late-stage da­ta on its ex­per­i­men­tal drug, abroc­i­tinib.

Abroc­i­tinib be­longs to a class of drugs called Janus ki­nase (JAK) in­hibitors — which have been plagued with safe­ty con­cerns. Named af­ter the two-faced Ro­man God Janus, the fam­i­ly con­sists of four en­zymes: JAK1, JAK2, JAK3 and TYK2, which are as­so­ci­at­ed with cy­tokine re­cep­tors on the sur­face of cells and form part of a path­way in­volved in in­flam­ma­to­ry and im­mune re­spons­es.

Abroc­i­tinib, a JAK1 in­hibitor, is thought to mod­u­late mul­ti­ple cy­tokines in­volved in the patho­phys­i­ol­o­gy of eczema in­clud­ing in­ter­leukin (IL)-4, IL-13, IL-31, and in­ter­fer­on gam­ma. On Fri­day, the US drug­mak­er said it had met goals of the 391-pa­tient JADE MONO-2 study, which test­ed two dos­es (100mg and 200mg once dai­ly) of the drug against a place­bo.

Con­sis­tent with the JADE MONO-1 tri­al, da­ta from this study showed that by week 12 the per­cent­age of pa­tients achiev­ing each co-pri­ma­ry ef­fi­ca­cy end­point, as well as each key sec­ondary end­point, with ei­ther dose of abroc­i­tinib was sta­tis­ti­cal­ly sig­nif­i­cant­ly high­er than place­bo. In ad­di­tion, a sta­tis­ti­cal­ly sig­nif­i­cant num­ber of pa­tients achieved a re­duc­tion in pru­ri­tus (se­vere itch­ing) by week 2, as mea­sured by a four-point or larg­er re­duc­tion in itch sever­i­ty mea­sured with the pru­ri­tus nu­mer­i­cal rat­ing scale (NRS).

De­tailed da­ta from JADE MONO-1 are ex­pect­ed at a Madrid con­fer­ence in Oc­to­ber, Pfiz­er $PFE said, adding that re­sults from a tri­al test­ing abroc­i­tinib against an ac­tive con­trol should read­out in spring 2020.

There are var­i­ous JAK in­hibitors on the mar­ket ap­proved for a range of im­mune-me­di­at­ed dis­eases. Pfiz­er al­ready has a JAK1/JAK3 in­hibitor — Xel­janz — in its port­fo­lio, al­though its use has been blight­ed by reg­u­la­to­ry re­stric­tions af­ter the high­er dose of the block­buster drug was found to be as­so­ci­at­ed with the risk of blood clots and death.

Eli Lil­ly’s $LLY JAK1/JAK2 Olu­mi­ant, mean­while, was ini­tial­ly re­ject­ed by the US agency due to safe­ty con­cerns — on­ly to even­tu­al­ly se­cure ap­proval for the low­er dose. Lil­ly’s part­ner, In­cyte $IN­CY, elect­ed to walk away from co-fund­ing the drug’s de­vel­op­ment as fears about the ben­e­fit-risk pro­file of the class of drugs ac­cu­mu­lat­ed. Last month Ab­b­Vie’s $AB­BV JAK1 upadac­i­tinib was cleared by the FDA for rheuma­toid arthri­tis with a black box warn­ing, a fea­ture an­a­lysts ex­pect will be in­cor­po­rat­ed in­to the la­bel of Gilead’s $GILD Gala­pa­gos-part­nered fil­go­tinib, should it se­cure ap­proval.

In terms of atopic der­mati­tis specif­i­cal­ly, Re­gen­eron $REGN and Sanofi’s $SNY Dupix­ent (chem­i­cal­ly known as dupilum­ab) was the first bi­o­log­ic to win ap­proval for the con­di­tion in 2017, and is now the de-fac­to leader in the mar­ket. It is en­gi­neered to in­hib­it the sig­nal­ing of IL-4 and IL-13 — two pro­teins that like­ly play a key role in the in­flam­ma­tion that un­der­lies eczema and a host of al­ler­gic dis­eases.

“While dupilum­ab (dupi) has set an ex­treme­ly high bar in AD, the evolv­ing com­pet­i­tive land­scape has not been quite as strong yet. Re­cent de­vel­op­ments serve as im­por­tant re­minders that the ‘crowd­ed’ AD land­scape may not look quite as con­gest­ed once the dust starts to set­tle and the win­ners cre­ate sep­a­ra­tion from the rest of the pack,” SVB Leerink an­a­lysts wrote in a note in June.

In Pfiz­er’s JADE MONO-2 study, abroc­i­tinib’s safe­ty pro­file was less than straight­for­ward. The fre­quen­cy of treat­ment-emer­gent ad­verse events was high­er in treat­ment arms ver­sus place­bo, and one pa­tient with co-ex­ist­ing car­dio­vas­cu­lar risk fac­tors died three weeks fol­low­ing the study from un­known eti­ol­o­gy — al­though the drug­mak­er said the event was not re­lat­ed to abroc­i­tinib.

“While we ex­pect ef­fi­ca­cy for abroc­i­tinib to be po­ten­tial­ly com­pa­ra­ble to Re­gen­eron’s Dupix­ent, many ques­tions re­main whether abroc­i­tinib is safe enough to be a for­mi­da­ble com­peti­tor to Dupix­ent,” Cred­it Su­isse’s Evan Seiger­man wrote in a note. “We ex­pect in­ten­si­fy­ing com­pe­ti­tion in AD over the next few years from nov­el JAK in­hibitors (abroc­i­tinib, Ab­b­Vie’s upadac­i­tinib) and nov­el bi­o­log­ics (name­ly tar­get­ing IL-13 and 33).”

So­cial im­age: AP

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

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Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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