No­var­tis banks on the promise of dig­i­tal ther­a­peu­tics in the man­age­ment of chron­ic dis­or­ders

Dig­i­tal ther­a­peu­tics may not have yet earned cult sta­tus with­in the health­care in­dus­try, but their promise in non-com­mu­ni­ca­ble dis­eases — that are of­ten caused or wors­ened by un­sa­vory be­hav­iors — is hard to de­ny, as Big Phar­ma makes a deep­er for­ay in­to clin­i­cal­ly-val­i­dat­ed dig­i­tal in­ter­ven­tions de­signed to en­cour­age sus­tain­able lifestyle changes to com­ple­ment tra­di­tion­al ther­a­peu­tics.

No­var­tis $NVS unit San­doz along with part­ner Pear Ther­a­peu­tics on Mon­day launched re­SET, an FDA-ap­proved dig­i­tal ther­a­peu­tic de­signed to de­liv­er cog­ni­tive be­hav­ioral ther­a­py over 12 weeks to pa­tients with sub­stance abuse dis­or­der (SUD) who are in out­pa­tient treat­ment un­der the su­per­vi­sion of a doc­tor.

Richard Fran­ci

“Adding re­SET to out­pa­tient ther­a­py en­hances be­hav­iors as­so­ci­at­ed with re­cov­ery. It lever­ages new tech­nol­o­gy to help pa­tients im­prove ab­sti­nence in sub­stances of abuse and stay in treat­ment pro­grams longer than out­pa­tient ther­a­py alone,” said San­doz chief Richard Fran­cis in a state­ment.

Poor treat­ment out­comes are the norm for SUD — a chron­ic, re­laps­ing dis­ease caused by the per­sis­tent use of al­co­hol and/or drugs — as in­con­sis­tent ac­cess and qual­i­ty of treat­ment as well as dis­par­i­ties in pay­ment and in­sur­ance for be­hav­ioral health ser­vices have cul­mi­nat­ed in low rates of ab­sti­nence and high dropout rates for a type of ther­a­py that is usu­al­ly re­source-in­ten­sive and ne­ces­si­tates face-to-face clin­i­cian in­ter­ac­tions. In 2014, about 21.5 mil­lion Amer­i­cans aged 12 and old­er (8.1%) were clas­si­fied with a sub­stance use dis­or­der in the past year, ac­cord­ing to es­ti­mates from HHS’ Sub­stance Abuse and Men­tal Health Ser­vices Ad­min­is­tra­tion.

The FDA ap­proved re­SET last year on the ba­sis of a NI­DA-spon­sored tri­al in­volv­ing 399 pa­tients with SUD. Pa­tients were ran­dom­ized to re­ceive stan­dard treat­ment — com­pris­ing in­ten­sive face-to-face coun­selling — or re­duced amount of face-to-face coun­selling plus the dig­i­tal ther­a­peu­tic. Pa­tients on the dig­i­tal ther­a­peu­tic more than dou­bled the rate of ab­sti­nence com­pared to stan­dard face-to-face coun­selling.

Dig­i­tal ther­a­peu­tics is an um­brel­la term that in­cludes tech­nol­o­gy such as wear­able de­vices, mo­bile apps and telemed­i­cine plat­forms — which is typ­i­cal­ly dri­ven by soft­ware to pre­vent, man­age, or treat dis­or­ders, in­de­pen­dent­ly or in con­cert with med­ica­tion and/or med­ical de­vices. These tools are large­ly de­signed to ad­dress chron­ic dis­eases such as di­a­betes, heart or res­pi­ra­to­ry dis­or­ders, by tar­get­ing be­hav­iors such as di­et, ex­er­cise and lifestyle that have a sig­nif­i­cant im­pact on the in­ci­dence and man­age­ment of dis­ease. Pre­scrip­tion dig­i­tal ther­a­peu­tics — such as re­SET and Abil­i­fy Mycite, the first dig­i­tal pill that car­ries an em­bed­ded sen­sor to track if pa­tients are tak­ing their med­ica­tion prop­er­ly — are val­i­dat­ed in ran­dom­ized clin­i­cal tri­als to demon­strate safe­ty and ef­fi­ca­cy.

Pear Ther­a­peu­tics is al­so de­vel­op­ing dig­i­tal ther­a­peu­tics for a host of oth­er dis­or­ders in­clud­ing schiz­o­phre­nia, PTSD and gen­er­al anx­i­ety dis­or­der. Al­though the rapid pen­e­tra­tion of smart­phones and tablets and low­er health­care costs have dri­ven the growth of the glob­al dig­i­tal ther­a­peu­tics mar­ket, pri­va­cy con­cerns could tem­per the pace of adop­tion. Still, ac­cord­ing to Al­lied Mar­ket Re­search the size of the mar­ket is set to grow to $7.83 bil­lion in 2025 from $1.75 bil­lion last year.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.