Frank Watanabe, Arcutis CEO

Ar­cutis' for­mu­la­tion of old As­traZeneca drug clears an­oth­er PhI­II test

Weeks af­ter rolling out its first pso­ri­a­sis treat­ment, Ar­cutis Bio­ther­a­peu­tics is rack­ing up more pos­i­tive Phase III da­ta for a sec­ond for­mu­la­tion of an old As­traZeneca drug.

The Phase III AR­REC­TOR tri­al test­ed rof­lu­mi­last foam in pa­tients with scalp and body pso­ri­a­sis, Ar­cutis said, and met both co-pri­ma­ry end­points as well as all sec­ondary end­points. Near­ly iden­ti­cal to its ap­proved drug, Zo­ryve, which is a cream, the foam is wa­ter-based and mois­tur­iz­ing — prop­er­ties that the biotech hoped could “over­come the chal­lenges of de­liv­er­ing top­i­cal drugs in hair-bear­ing ar­eas of the body.” Ar­cutis has pre­vi­ous­ly com­pared it to hair mousse.

The new da­ta bur­nish Ar­cutis’ promise of de­vel­op­ing easy-to-use for­mu­la­tions of ex­ist­ing drugs for con­di­tions of the skin.

Ac­cord­ing to the com­pa­ny, plaque pso­ri­a­sis im­pacts nine mil­lion peo­ple in the US, 40% of whom have pso­ri­a­sis that af­fects the scalp.

“Top­i­cal ther­a­pies are first-line treat­ments for scalp and body pso­ri­a­sis, but cur­rent op­tions have lim­i­ta­tions in­clud­ing aes­thet­ic ac­cept­abil­i­ty, tol­er­a­bil­i­ty, ef­fec­tive­ness, and lim­it­ed du­ra­tion of use, which can lead to poor out­comes and sig­nif­i­cant­ly im­pact pa­tients’ qual­i­ty of life,” said Melin­da Good­er­ham, study au­thor and an in­ves­ti­ga­tor with Pro­bity Med­ical Re­search.

In the tri­al, 67.3% of pa­tients treat­ed with the drug achieved Scalp-In­ves­ti­ga­tor Glob­al As­sess­ment (S-IGA) suc­cess at week eight, com­pared to 28.1% of in­di­vid­u­als treat­ed with a match­ing ve­hi­cle foam (p<0.0001). At the same time point, 46.5% in the rof­lu­mi­last foam group saw Body-In­ves­ti­ga­tor Glob­al As­sess­ment (B-IGA) suc­cess, ver­sus 20.8% in the com­para­tor arm (p<0.0001).

The drug al­so spurred im­prove­ments in sec­ondary end­points such as scalp itch and over­all itch.

A PDE4 in­hibitor, rof­lu­mi­last is the ac­tive in­gre­di­ent in As­traZeneca’s COPD drug Dalire­sp. It be­longs to the same class as Ote­zla, which has long been used to treat skin and oth­er in­flam­ma­to­ry con­di­tions.

Ar­cutis paid As­traZeneca $1 mil­lion in cash, plus a num­ber of its own shares, to de­vel­op the com­pound for der­ma­to­log­i­cal us­es.

The biotech added that the most com­mon­ly ex­pe­ri­enced ad­verse events among pa­tients were headache, di­ar­rhea and Covid-19. 2.5% of par­tic­i­pants in the rof­lu­mi­last foam group dis­con­tin­ued treat­ment due to these events. In the ve­hi­cle group, the dis­con­tin­u­a­tion rate was 1.3%.

The re­sults fol­low a pos­i­tive read­out for rof­lu­mi­last foam in se­b­or­rhe­ic der­mati­tis, for which Ar­cutis is plan­ning an NDA fil­ing ear­ly next year — with a sN­DA in scalp and body pso­ri­a­sis to fol­low.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.