David Zaccardelli, Verona Pharma CEO

Verona’s COPD drug shines in PhI­II study, po­ten­tial­ly clear­ing path to FDA — shares jump

UK-based Verona Phar­ma’s COPD drug, en­sifen­trine, has suc­ceed­ed in its Phase III tri­al, paving the way for a pos­si­ble FDA ap­proval.

In Verona’s Phase III EN­HANCE-2 study, rough­ly 800 pa­tients with mod­er­ate to se­vere COPD re­ceived en­sifen­trine or place­bo through a neb­u­liz­er twice a day for 24 weeks. At 12 hours post-treat­ment on week 12, the place­bo-cor­rect­ed change in forced ex­pi­ra­to­ry vol­ume (FEV1) — a stan­dard mea­sure of lung func­tion that tests how much breath one can force­ful­ly ex­hale in one sec­ond — was 94 mL, lead­ing the tri­al to meet its pri­ma­ry end­point.

The da­ta took in­vestors’ breath away, as Verona shares $VR­NA jumped more than 70% in ear­ly Tues­day trad­ing.

Ap­prox­i­mate­ly 52% of pa­tients had re­ceived back­ground COPD ther­a­py, ei­ther a long-act­ing mus­carinic an­tag­o­nist (LAMA) or a long-act­ing be­ta-ag­o­nist (LA­BA). Ad­di­tion­al­ly, ap­prox­i­mate­ly 15% of all sub­jects re­ceived in­haled cor­ti­cos­teroids (ICS) with con­comi­tant LAMA or LA­BA. How­ev­er, the re­sults of these spe­cif­ic sub­groups were not shared.

An­to­nio Anzue­to

“These da­ta, along with re­sults from our on­go­ing Phase 3 tri­al, EN­HANCE-1, which is on track to be re­port­ed around the end of 2022, if sim­i­lar­ly pos­i­tive, are ex­pect­ed to sup­port the sub­mis­sion of a New Drug Ap­pli­ca­tion to the US Food and Drug Ad­min­is­tra­tion in the first half of 2023,” said Verona’s CEO David Za­c­cardel­li in a press state­ment.

The study al­so met its sec­ondary end­point of im­prov­ing lung func­tion. At week 12, the peak FEV1 in the 0 to 4 hours af­ter dos­ing with en­sifen­trine was high­er than the place­bo by 146 mL. The place­bo-cor­rect­ed morn­ing trough FEV1 at week 12 was 49 mL.

While the study achieved its pri­ma­ry and sec­ondary end­points, the drug failed to beat place­bo on mea­sures of COPD symp­toms and qual­i­ty of life.

An­to­nio Anzue­to, a pro­fes­sor of med­i­cine and chief of pul­monary at South Texas Vet­er­ans Health­care Sys­tem, said in a re­lease:

En­sifen­trine has demon­strat­ed clear im­prove­ments in lung func­tion in ad­di­tion to fa­vor­able safe­ty re­sults. I am ex­treme­ly ex­cit­ed by the clin­i­cal­ly mean­ing­ful 42% re­duc­tion in the rate of ex­ac­er­ba­tions ob­served over 24 weeks in these symp­to­matic pa­tients, many re­ceiv­ing back­ground ther­a­py.

Verona has tout­ed en­sifen­trine, or RPL554, as the first po­ten­tial ther­a­py for res­pi­ra­to­ry dis­eases that acts as both a bron­chodila­tor and an­ti-in­flam­ma­to­ry agent in a soli­tary com­pound. The biotech, found­ed in 2005 and built sole­ly around en­sifen­trine, says the mol­e­cule is the first that can both widen pa­tients’ air­ways and re­duce in­flam­ma­tion.

But it hasn’t al­ways been smooth sail­ing. In 2019, the drug failed to sig­nif­i­cant­ly im­prove lung func­tion in a three-day study when giv­en on top of cur­rent COPD drugs. Last Feb­ru­ary, though, a longer study found the neb­u­lized form did im­prove lung func­tion when giv­en on top of ex­ist­ing drugs, and Verona was able to raise near­ly $200 mil­lion to launch a pair of piv­otal Phase III stud­ies, test­ing the drug both alone and in com­bi­na­tion.

Mean­while, oth­er re­cent drugs for COPD in­clude As­traZeneca’s FDA-ap­proved three-in-one in­haler Breztri Aeros­phere, which helps in the main­te­nance of COPD.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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