Roche flash­es new 16-week bis­pe­cif­ic AMD da­ta, set­ting eyes on pair of PhI­II tri­als

While Roche awaits re­sults from a pair of large Phase III tri­als, the Swiss phar­ma is tout­ing an­oth­er round of da­ta from a small­er study on its wet mac­u­lar de­gen­er­a­tion (nAMD) bis­pe­cif­ic an­ti­body, faricimab.

Al­though new, the da­ta large­ly con­firm re­sults Roche and its Genen­tech sub­sidiary flashed from the Phase II study two years ago, with both rounds sug­gest­ing that the ex­per­i­men­tal drug could be giv­en once every 12 or 16 weeks, as op­posed to the 4 weeks re­quired for their long-run­ning AMD block­buster Lu­cen­tis.

Carl Danzig

“Tra­di­tion­al­ly, the stan­dard of care is once every 4 weeks,” Carl Danzig, the study’s lead in­ves­ti­ga­tor, told End­points News. ”And there have been many re­al world stud­ies that show treat­ment bur­den is re­al. Pa­tients are not able to main­tain their vi­sion be­cause they are not able to main­tain month­ly vis­its to the doc­tor.”

The im­pact of the new drug, though, may be lim­it­ed, both eco­nom­i­cal­ly and for pa­tients. Roche is bet­ting on faricimab, as Lu­cen­tis is set to come off patent pro­tec­tion in the US lat­er this year and in Eu­rope soon af­ter. But the mar­ket for long-act­ing AMD drugs is now crowd­ed. Since the study be­gan in 2017, the mar­ket’s top sell­ing wet-AMD drug, Reg­neron’s Eylea, has been ap­proved for a 12-week dose. And late last year, the FDA ap­proved No­var­tis’s Beovu for both 8-week and 12-week dos­ing reg­i­mens.

Is 16 weeks that much of an ad­van­tage over 12? Danzig ac­knowl­edged it’s less of a jump than mov­ing from 4 weeks to 12, but point­ed to the method by which these drugs are ad­min­is­tered.

“I think for pa­tients across the board, the few­er nee­dles they get in their eye, the hap­pi­er they are,” Danzig, who di­rects vit­reo-reti­nal ser­vices at the Rand Eye in­sti­tute, said. “It doesn’t sound like a huge leap but for that pa­tient, one less nee­dle in an eye means a lot.”

In the lat­est 52-week da­ta, re­leased as an ab­stract for the As­so­ci­a­tion for Re­search in Vi­sion and Oph­thal­mol­o­gy, pa­tients tak­ing faricimab once every 12 weeks or once every 16 weeks showed “com­pa­ra­ble” im­prove­ments in vi­sion and anato­my. The le­sions, for in­stance, shrunk 4.2, 5.4, and 4.5 mm for the 16 week faricimab, 12 week faricimab, and 4 week Lu­cen­tis arm, re­spec­tive­ly. The leak­age age shrunk 4.6, 5.6, and 5.3 mm.

Around two thirds of the pa­tients showed no signs of dis­ease pro­gres­sion at 24 weeks, or 12 weeks since the last ini­ti­a­tion dose, mean­ing they could po­ten­tial­ly have gone to the 16 week arm, Danzig said.

Even if faricimab fails to dif­fer­en­ti­ate it­self on ef­fi­ca­cy or dos­ing, the drug will stand out sci­en­tif­i­cal­ly. It is the first of the AMD an­ti­bod­ies to be bis­pe­cif­ic, tar­get­ing both the long-trot­ted VEGF-path­way and an­giopoi­etin-2, with the goal of sta­bi­liz­ing the leak­age that caus­es vi­sion loss from two dif­fer­ent an­gles. The an­giopoi­etin-2 path­way was briefly tar­get­ed ex­per­i­men­tal­ly by sci­en­tists for di­a­bet­ic retinopa­thy, Danzig said, but has large­ly gone un­ex­plored.

All eyes now are on two Phase III tri­als Roche be­gan en­rolling last year. Those will test faricimab di­rect­ly against Eylea in around 1,300 pa­tients, po­ten­tial­ly set­ting up a reg­u­la­to­ry de­ci­sion in 2022 or 2023.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.