Jen Goldsack, Digital Medicine Society CEO

Ab­b­Vie, Janssen, No­var­tis, Pfiz­er and UCB to joint­ly ad­vance 'dig­i­tal' end­point for atopic der­mati­tis

As the com­pe­ti­tion around the lu­cra­tive atopic der­mati­tis space heats up, Ab­b­Vie, Janssen, No­var­tis, Pfiz­er, and UCB are com­ing to­geth­er in a pre-com­pet­i­tive col­lab­o­ra­tion to ad­vance noc­tur­nal scratch as a “dig­i­tal” end­point for the skin con­di­tion.

The Big Phar­mas are hop­ing to dri­ve the broad­er ac­cep­tance of noc­tur­nal scratch as a mean­ing­ful end­point for atopic der­mati­tis, and for dig­i­tal end­points in gen­er­al.

Pfiz­er re­searchers pub­lished a pa­per in March in a Na­ture part­ner jour­nal, in which they ex­plain how wear­able sen­sors “can pro­vide nov­el, ob­jec­tive mea­sures of night­time scratch­ing and sleep; how­ev­er, many cur­rent ap­proach­es were not de­signed for pas­sive, un­su­per­vised mon­i­tor­ing dur­ing dai­ly life. In this work, we present the de­vel­op­ment and an­a­lyt­i­cal val­i­da­tion of a method that se­quen­tial­ly process­es epochs of sam­ple-lev­el ac­celerom­e­ter da­ta from a wrist-worn de­vice to pro­vide con­tin­u­ous dig­i­tal mea­sures of night­time scratch­ing and sleep quan­ti­ty.”

Pfiz­er faces an in­creas­ing­ly crowd­ed atopic der­mati­tis space as Ab­b­Vie’s block­buster Rin­voq is cur­rent­ly un­der FDA re­view for the in­di­ca­tion, and ac­cord­ing to SVB Leerink biotech an­a­lyst Ge­of­frey Porges, “looks spec­tac­u­lar­ly ef­fec­tive at its high­est dose.” But he said Pfiz­er’s abroc­i­tinib, its next-gen fol­low-up on Xel­janz, “con­tin­ues to look meh.”

The col­lab­o­ra­tion be­tween the com­pa­nies is a bit of an ex­plorato­ry mis­sion too as the FDA has nev­er au­tho­rized or ap­proved any new med­ical prod­ucts on the ba­sis of these dig­i­tal end­points, which are de­fined as end­points that use sen­sors to cap­ture ex­ist­ing mea­sures in a new way, ac­cord­ing to an op-ed by Jen Gold­sack, CEO of the Dig­i­tal Med­i­cine So­ci­ety.

DiMe is help­ing these five bio­phar­ma com­pa­nies in their col­lab­o­ra­tion and be­lieves that dig­i­tal end­points present an op­por­tu­ni­ty to pro­vide “a more mean­ing­ful and com­plete un­der­stand­ing” of pa­tients’ con­di­tions and re­spons­es, and po­ten­tial­ly re­duce the time and cost of bring­ing new ther­a­pies to mar­ket.

But for the FDA, which doesn’t use the term “dig­i­tal end­point,” the chal­lenges of cap­tur­ing pa­tient-re­port­ed out­comes are nu­mer­ous, and can in­clude every­thing from the in­stru­ment used ap­pro­pri­ate­ly in the tri­al, to how the spon­sor ad­e­quate­ly mea­sured the re­sults, which are of­ten con­veyed in a “score,” and may be dif­fi­cult to un­der­stand the mag­ni­tude of the ben­e­fit, par­tic­u­lar­ly in re­la­tion to safe­ty risks, ac­cord­ing to an FDA pre­sen­ta­tion.

Di­ane Stephen­son, ex­ec­u­tive di­rec­tor of the Crit­i­cal Path for Parkin­son’s, al­so ex­plained some of the con­fu­sion around dig­i­tal end­points at a pa­tient-fo­cused drug de­vel­op­ment work­shop in 2019 at FDA.

“I’ve been told many times that peo­ple think that if you use an FDA cleared de­vice or an ap­proved de­vice –­ 510(k) cleared de­vice — then that au­to­mat­i­cal­ly means that that de­vice will be ac­cept­ed as an end­point, a dig­i­tal end­point in a tri­al, so that’s in­cor­rect,” she said.

“As we’ve heard to­day many times that de­f­i­n­i­tions of how to de­fine what would be achieved with an end­point are quite unique,” she not­ed, while point­ing to the FDA’s for­mal qual­i­fi­ca­tion process for drug de­vel­op­ment tools. “So this is just some re­al­ly im­por­tant ground­ing that we try to con­tin­ue to re­mind, es­pe­cial­ly spon­sors who are se­lect­ing dig­i­tal tools for use pri­mar­i­ly as ex­plorato­ry end­points, but their goal re­al­ly is a dig­i­tal end­point in a tri­al,” Stephen­son said.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.