Te­va turns the last cor­ner in the CGRP mi­graine drug race with its 2nd round of promis­ing PhI­II da­ta

Te­va has brought in its sec­ond suc­cess­ful Phase III study of its CGRP mi­graine drug fre­manezum­ab (TEV-48125), rack­ing up a fresh slate of promis­ing da­ta across all end­points that will soon be pack­aged and de­liv­ered in­to the hands of reg­u­la­tors.

Te­va re­cruit­ed a heav­i­ly af­flict­ed group of pa­tients for this episod­ic study with a mean num­ber of 9.1 mi­graine days per month go­ing in. Their $TE­VA core da­ta boils down to this: a 1.5-day ad­van­tage in re­duced mi­graine days for the drug arm, putting it in the mix of around 2 days im­prove­ment across a full slate of CGRP ri­vals test­ed in a wide va­ri­ety of mid- and late-stage stud­ies.

Umer Raf­fat at Ever­cor­eISI has been fol­low­ing the num­bers, and high­light­ed this point:

(I)n to­day’s da­ta, there is an­oth­er impt tid­bit:  Te­va prospec­tive­ly ran­dom­ized a sub­group of pa­tients in this episod­ic tri­al on sta­ble pro­phy meds … and in this sub­group, Te­va showed a 1.7-2 day stat sig mi­graine day re­duc­tion (both for quar­ter­ly and month­ly dos­es).  This may al­so help from la­bel­ing per­spec­tive.

Raf­fat de­clined to com­pare these new num­bers for episod­ic mi­graine with Am­gen or Lil­ly, not­ing the dif­fer­ence in tri­al length that makes it im­pos­si­ble to line up the stats.

The de­tails:

Fre­manezum­ab giv­en month­ly im­proved the av­er­age num­ber of mi­graine days, rel­a­tive to base­line, by 41.6% for the du­ra­tion of the tri­al (-3.7 days vs. -2.2 days for place­bo, p < 0.0001). Num­ber of days with dis­abil­i­ty were de­creased by 64.7% (p =0.0021) and med­ica­tion con­sump­tion was de­creased by 39.0%( p < 0.0001). The quar­ter­ly SC dose, which was unique­ly test­ed in this pro­gram, al­so yield­ed high­ly sig­nif­i­cant re­sults for de­crease in mi­graine days (-3.4 days or 37.0%, p < 0.0001) and for all oth­er com­par­isons. Al­so unique to this de­vel­op­ment, both dose reg­i­mens high­ly sig­nif­i­cant­ly im­proved mi­graine in sub­jects on sta­ble dos­es of oth­er pro­phy­lac­tic med­ica­tions (-4.0 days for month­ly dose vs -2.0 days for place­bo, p = 0.001; -3.7 days for quar­ter­ly dose, p = 0.006).

It all looks good enough for an ap­proval, with de­cent odds that this drug will ap­pear on the mar­ket along­side a slate of ri­vals next year. Te­va, though, is hop­ing that its month­ly and quar­ter­ly dos­ing reg­i­mens will help dif­fer­en­ti­ate it from the com­pe­ti­tion to come.

Michael Hay­den, Te­va

“Te­va’s HA­LO tri­als are the on­ly Phase III an­ti-CGRP stud­ies to demon­strate ef­fi­ca­cy with both month­ly and quar­ter­ly dos­ing for chron­ic and episod­ic pa­tients and in pa­tients al­ready re­ceiv­ing pre­ven­tion ther­a­pies. This is a ma­jor ad­vance on ex­ist­ing da­ta. The ef­fi­ca­cy and rapid on­set, as both add-on and monother­a­py, quar­ter­ly dos­ing, and ef­fect on dis­abil­i­ty and qual­i­ty of life in­di­cate that this ther­a­py has the po­ten­tial to set new and dif­fer­ent bench­marks in the re­lief of mi­graine suf­fer­ing,” said Te­va R&D chief Michael Hay­den in a state­ment. “We are im­mense­ly proud to be able to bring to the mi­graine com­mu­ni­ty the hope that they might soon have a new op­tion that could pro­vide a mean­ing­ful re­duc­tion in the mi­graine bur­den pa­tients ha­bit­u­al­ly suf­fer.”

A few weeks ago it was Eli Lil­ly’s $LLY turn to cel­e­brate its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. Lit­tle Alder $AL­DR is al­so plan­ning to wage a com­mer­cial war with their drug. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front. No­var­tis $NVS and Am­gen $AMGN — cred­it­ed as the fron­trun­ners in the race to the first OK — were the first to come up with pos­i­tive Phase III da­ta for erenum­ab (AMG 334) last fall, when a 70 mg dose scored an av­er­age 1.1 day per month drop in mi­graine episodes.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.