It's not just the an­ti­bod­ies: Eli Lil­ly bur­nish­es its sec­ond EUA in play with new Covid-19 da­ta on Olu­mi­ant plus remde­sivir

Eli Lil­ly is on a roll.

Days af­ter re­port­ing pos­i­tive da­ta for its Covid-19 neu­tral­iz­ing an­ti­bod­ies, the phar­ma gi­ant said adding its JAK in­hibitor Olu­mi­ant to Gilead’s remde­sivir cut the risk of death — al­though the re­sult wasn’t sta­tis­ti­cal­ly sig­nif­i­cant.

New da­ta from ACTT-2, an adop­tive treat­ment tri­al con­duct­ed by the NIH, are in line with what in­ves­ti­ga­tors dis­closed a month ago re­gard­ing im­prove­ments in time to re­cov­ery.

Lil­ly said it’s talk­ing to reg­u­la­tors about a po­ten­tial EUA cov­er­ing adult pa­tients hos­pi­tal­ized for the in­fec­tion. ACTT-1, the pre­de­ces­sor tri­al that es­tab­lished remde­sivir as a stan­dard treat­ment in the hos­pi­tal set­ting, al­so paved the way for its au­tho­riza­tion.

Here’s what we al­ready know: The com­bi­na­tion of Olu­mi­ant, or baric­i­tinib, with remde­sivir helped pa­tients re­cov­er faster than remde­sivir alone, cut­ting the me­di­an time to re­cov­ery by about one day. Re­cov­ery was de­fined by meet­ing the cri­te­ria for hos­pi­tal dis­charge.

Lil­ly has now re­vealed that the re­duc­tion was from 8 to 7 days (p = 0.04), and that the ben­e­fits are most pro­nounced among pa­tients re­quir­ing sup­ple­men­tal oxy­gen or non-in­va­sive ven­ti­la­tion at base­line.

Pre­sent­ing at a spe­cial con­fer­ence, NI­AID as­so­ciate di­rec­tor for clin­i­cal re­search John Beigel al­so dis­cussed a sec­ondary end­point for the first time. Pa­tients tak­ing Olu­mi­ant/remde­sivir were 30% more like­ly to im­prove in clin­i­cal sta­tus af­ter 15 days than those on­ly giv­en remde­sivir.

Prob­ing in­to mor­tal­i­ty through day 29, he ob­served a nu­mer­i­cal de­crease from 7.8% to 5.1%, but the p-val­ue failed to hit the bar at 0.09.

The full analy­sis is still on­go­ing and a peer re­viewed man­u­script has yet to ma­te­ri­al­ize. But the re­sults mark fur­ther val­i­da­tion for its hy­poth­e­sis that JAK is the right tar­get to hit in or­der to damp­en dan­ger­ous im­mune re­spons­es caused by SARS-CoV-2 while the IL-6 re­pur­pos­ing the­o­ry bites the dust (al­though Roche ap­pears to be hold­ing out hope).

The FDA’s ac­tions and physi­cian re­sponse here will al­so test how re­cep­tive reg­u­la­tors and doc­tors are to in­cre­men­tal ben­e­fits of­fered by add-on drugs.

In the ACTT-1 tri­al, remde­sivir was shown to have sped up re­cov­ery by 4 days com­pared to best sup­port­ive care. There was a 3-per­cent­age-point im­prove­ment in mor­tal­i­ty that was sta­tis­ti­cal­ly in­signif­i­cant. Al­though Gilead lat­er re­leased more da­ta from sin­gle-arm stud­ies, skep­tics re­mained leery of the an­tivi­ral drug’s re­al ef­fect.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.