Lit­tle vTv once again cir­cles sub­group num­ber, strug­gling to find some­thing good to say about failed Alzheimer's drug

The biotech vTv raised $117 mil­lion from their 2015 IPO $VTVT based on a pitch that they could take a failed Alzheimer’s drug from Pfiz­er and fol­low a trail of pos­i­tive sub­set da­ta to a big win. That didn’t work, with Phase A of the piv­otal pro­gram fail­ing both co-pri­ma­ry end­points re­cent­ly.

In fact, the drug arm once again did worse than a place­bo group.

Steve Hol­combe

But now they’ve had a chance to do some post hoc analy­sis of the first round of Phase III da­ta, and they’re back to spot­light­ing a pos­i­tive batch of da­ta for a sub­pop­u­la­tion.

So here it is. In a state­ment out Wednes­day night, vTv says that a group of pa­tients with a con­cen­tra­tion of the drug azeli­ragon un­der a bar of 7.5 ng/mL hit a sta­tis­ti­cal­ly sig­nif­i­cant score for ADAS-cog, p=0.02. It failed on an­oth­er score — CDR-sb — with a p-val­ue of 0.06. And they want to re­vise their sta­tis­ti­cal analy­sis plan for the FDA.

The sub­group in­clud­ed 48 of the 400 pa­tients in the study, which was di­vid­ed be­tween the drug and a place­bo. 

The biotech’s shares — which were crushed on the ini­tial Phase III fail­ure — bounced high­er in pre-mar­ket trad­ing Thurs­day. Whether they can sus­tain that with ad­di­tion­al sub­group analy­sis re­mains to be seen, but vTv is once again go­ing down a path that has led to the de­struc­tion of bil­lions of dol­lars of in­vestors’ cash on a wide range of drug stud­ies.

The com­pa­ny de­signed the 18-month Phase III pro­gram based on da­ta that the small 5 mg dose of the drug per­formed well in Pfiz­er’s study, where the 20 mg failed. And just like about every­thing else in the Alzheimer’s pipeline, that strat­e­gy has proved to be a re­peat los­er.

In­vestors in the field keep buy­ing in­to the idea that ac­quir­ing shares in an Alzheimer’s stock is just like buy­ing lot­tery tick­ets — ul­tra high risk with the pos­si­bil­i­ty of ul­tra high re­wards. But with no win­ners in more than a decade, that ar­gu­ment has been wear­ing thin.

This biotech, though, is still de­ter­mined to keep rolling the dice.

“We are en­cour­aged by the pos­i­tive im­prove­ments in cog­ni­tive and func­tion­al out­comes rel­a­tive to place­bo based up­on low azeli­ragon con­cen­tra­tion lev­els,” said vTv CEO Steve Hol­combe in a state­ment. “With this un­der­stand­ing, we are con­tin­u­ing to an­a­lyze the da­ta and then plan to ex­am­ine the rel­e­vant pop­u­la­tion prospec­tive­ly in the Part B study and an­nounce re­sults in June.”

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid 19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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Flex­ion se­cures Chi­na deal for os­teo­poro­sis drug; Strug­gling to find a buy­er, Ako­rn throws in the tow­el

→ Flexion may be hitting the brakes on clinical trials, including one for its osteoporosis Zilretta, but that’s not stopping the biotech from plotting regulatory action in China. Hong Kong Tainuo has committed $10 million upfront to seize the development and commercialization rights to Zilretta, with plans to apply for a clinical trial in China by the end of the year. Flexion, which said it has 10 months of finished goods in the US and 12 months of active pharmaceutical ingredient available, will supply all products to the Chinese partner.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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