Gilead, Gala­pa­gos re­port com­pet­i­tive num­bers for first big PhI­II read­out for fil­go­tinib in rheuma­toid arthri­tis

Gilead $GILD and its part­ners at Gala­pa­gos $GLPG of­fered their first cut of Phase III da­ta for fil­go­tinib, their late-stage can­di­date for dis­rupt­ing the rheuma­toid arthri­tis mar­ket. And while they may have come in nu­mer­i­cal­ly a lit­tle be­hind their big ri­val at Ab­b­Vie, re­searchers seem to have gained a good safe­ty pro­file and some com­pet­i­tive num­bers that help jus­ti­fy Gilead’s $725 mil­lion up­front near­ly 3 years ago.

John McHutchi­son

Look­ing at a snap­shot of the da­ta, 100 mg fil­go­tinib hit a 57.5% mark for ACR20 at 12 weeks and 66% for 200 mg. At the 24 week mark, that trans­lat­ed to 54.9% and 69.4%. The clin­i­cal re­mis­sion rate was 25.5% and 22.4% at 12 weeks, 26.1% and 30.6% at 24 weeks.

That was all much bet­ter than the place­bo arms in this study — hit­ting the pri­ma­ry and the key sec­on­daries in sight. Fil­go­tinib, though, is the drug that Ab­b­Vie $AB­BV aban­doned to stick with upadac­i­tinib (ABT-494), which in one Phase III hit with 71% of pa­tients achiev­ing ACR20 and 29% achiev­ing clin­i­cal re­mis­sion at week 12.

Gilead’s shares jumped 2.3% on the news in af­ter-mar­ket trad­ing while Gala­pa­gos saw its stick surge 18% on Wednes­day.

This isn’t a head-to-head study, of course, but these days it may as well be. 

Upadac­i­tinib, like oth­er JAK in­hibitors such as Eli Lil­ly’s baric­i­tinib, has had some safe­ty is­sues to con­tend with. In this study of fil­go­tinib, the com­pa­nies gave them­selves high marks on safe­ty, with no tri­al deaths to re­port; 3.4, 5.2 and 4.1% of the pa­tients in the place­bo, 100mg and 200mg groups re­port­ing a se­ri­ous ad­verse event. There was “one case of non-se­ri­ous reti­nal vein oc­clu­sion in the fil­go­tinib 200 mg group and no re­ports of deep ve­nous throm­bo­sis or pul­monary em­bolism.”

There were two big MACE events, but they were split be­tween the drug and place­bo arms.

Leerink’s Ge­of­frey Porges sized up the press re­lease and says this one could be a game chang­er, with an im­proved 80% chance of suc­cess at the FDA.

At least based on the com­pa­nies’ press re­lease last night, this hy­poth­e­sis is in­deed valid and sup­ports the no­tion that while fil­go­tinib may not be the first of these drugs to mar­ket (like­ly the last), it might be the best.

Jef­feries’ Michael Yee was quick to re­mark:

The good news is this is the first pos­i­tive study and helps to de-risk the ini­tial read­outs for the fran­chise and looks pret­ty clean. We see this as a mod­est but good cat­a­lyst for GILD giv­en re­cent stock per­for­mance over the last few months and some frus­trat­ed in­vestor sen­ti­ment. The next ma­jor read­outs are in H1:19, al­though the key big­ger pic­ture read­out that Street will want to know in time is the Phase II/III UC male tox­i­c­i­ty study which is still en­rolling, and GILD is work­ing hard to ac­cel­er­ate en­roll­ment which may in­clude open­ing it up to oth­er in­di­ca­tions and lots more sites.

“These ini­tial Phase III da­ta sup­port the po­ten­tial of fil­go­tinib, in com­bi­na­tion with se­lect dis­ease mod­i­fy­ing drugs, to help pa­tients with ac­tive rheuma­toid arthri­tis who do not ad­e­quate­ly re­spond to cur­rent bi­o­log­ic dis­ease mod­i­fy­ing agents,” says Gilead CSO John McHutchi­son. “These da­ta are par­tic­u­lar­ly en­cour­ag­ing as we look ahead to Phase 3 re­sults from the on­go­ing FINCH 1 and 3 tri­als, which are ex­plor­ing fil­go­tinib in oth­er pop­u­la­tions of pa­tients with rheuma­toid arthri­tis.”

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.