Covid-19 af­flicts Eli Lil­ly’s share price and a KRAS drug gets tossed, but Jar­diance win salves the wound as an an­ti­body ef­fort ad­vances to PhII

Shares of Eli Lil­ly $LLY tum­bled close to 2% on Thurs­day in a tox­ic re­ac­tion to its mixed rev­enue per­for­mance in the face of the pan­dem­ic dur­ing Q2. But in­vestors found so­lace in a promis­ing Phase III read­out for Jar­diance, as their block­buster con­tin­ues to blaze a trail to much big­ger mar­kets.

Their SGLT2 in­hibitor beat out a place­bo in re­duc­ing the risk for the com­pos­ite of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion due to heart fail­ure, when added to stan­dard of care. The drug hit the pri­ma­ry end­point, added Lil­ly, not­ing that the full da­ta read­out will come at the Eu­ro­pean So­ci­ety of Car­di­ol­o­gy (ESC) Con­gress at the end of Au­gust.

Swept out in the Q2 cleanup, though, was Lil­ly’s ear­ly stage KRAS G12C drug LY3499446. Af­ter Am­gen spurred hope for a big KRAS play, with a va­ri­ety of play­ers look­ing to make progress on a tar­get that has long been con­sid­ered un­drug­gable, added da­ta have dimmed hopes for broad ap­plic­a­bil­i­ty. And now Lil­ly, which has been steadi­ly re­work­ing its on­col­o­gy pipeline and brand un­der Loxo chief Josh Bilenker, wants out. The key is­sue was safe­ty.

Lil­ly’s state­ment to End­points News:

While we were ini­tial­ly ex­cit­ed to ex­plore the po­ten­tial of LY3499446, we saw un­ex­pect­ed tox­i­c­i­ty and de­cid­ed not to in­vest ad­di­tion­al time and re­sources in a pro­gram that may not be as clin­i­cal­ly and com­pet­i­tive­ly rel­e­vant as we hoped. We are tak­ing a very dis­ci­plined ap­proach to build­ing our pipeline and are sin­gu­lar­ly fo­cused on dis­cov­er­ing and de­vel­op­ing med­i­cines that we be­lieve will be tru­ly dif­fer­en­ti­at­ed and mat­ter to pa­tients.

The news on Jar­diance, one of their fastest grow­ing fran­chis­es at Lil­ly, will be sweet­er for in­vestors.

Vamil Di­van at Mizuho not­ed:

(I)t is clear to us that to­day’s news, com­bined with pos­i­tive news we have seen re­cent­ly from SGLT-2 in­hibitors in pa­tients with kid­ney dis­ease, is go­ing to open up large new mar­kets for the SGLT-2 class, with Jar­diance the clear mar­ket leader.

Oth­er drugs in the class, in­clud­ing Farx­i­ga from As­traZeneca, have been mak­ing their own ad­vances on the car­dio side of the med­ical equa­tion.

“The re­sults of the EM­PER­OR-Re­duced tri­al in­di­cate that SGLT2 in­hibitors have the po­ten­tial to be­come a new stan­dard of care for this dis­ease, which will be a mean­ing­ful ad­di­tion to cur­rent­ly es­tab­lished treat­ments,” not­ed Mil­ton Pack­er, chair of the ex­ec­u­tive com­mit­tee for the de­vel­op­ment pro­gram.

An­a­lysts have al­so been close­ly fol­low­ing Lil­ly’s an­ti­body de­vel­op­ment pro­gram for CoV555, part­nered with Ab­Cellera. In their Q2 state­ment, the com­pa­ny said they had com­plet­ed dos­ing in the first study and launched a Phase II tri­al, with da­ta ex­pect­ed in the fourth quar­ter.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.