Eli Lil­ly ush­ers up-and-com­ing GIP/GLP-1 drug in­to PhI­II as No­vo Nordisk ri­val wows with im­pres­sive re­sults

With No­vo Nordisk’s GLP-1 drug Ozem­pic (semaglu­tide) on its tail, Eli Lil­ly has round­ed up some mid-stage da­ta to show it has the right can­di­date to fol­low on Trulic­i­ty’s block­buster suc­cess in the com­pet­i­tive di­a­betes mar­ket.

In­ves­ti­ga­tors re­port that LY3298176, a dual GIP and GLP-1 re­cep­tor ag­o­nist, out­per­formed both place­bo and Trulic­i­ty (du­laglu­tide) in terms of blood sug­ar re­duc­tion and weight loss for pat­ints with type 2 di­a­betes. And while cross-tri­al com­par­isons al­ways war­rant cau­tion, the drug ap­pears to of­fer a siz­able ad­di­tion­al ef­fect over GLP monother­a­pies.

Like GLP-1, GIP is an in­cretin hor­mone tied to in­sulin se­cre­tion.

“This drug is set­ting up to be per­haps the most crit­i­cal part of LLY’s di­a­betes strat­e­gy go­ing fwd … es­pe­cial­ly in the face of No­vo’s new launch­es,” Ever­core ISI an­a­lyst Umer Raf­fat writes in a note.

In­vestors were pay­ing close at­ten­tion. Lil­ly’s stock $LLY shot up 4%, a big deal for big-cap com­pa­ny, while No­vo’s shares $NVO slid 7%.

On the pri­ma­ry ef­fi­ca­cy mea­sure — change in HbA1c from base­line to 26 weeks — 90% of those who re­ceived the 10 mg dose of LY3298176 achieved the rec­om­mend­ed HbA1c tar­get of 7% of less; the 5 mg group record 69.1% and the 15 mg group, 77.4%. Mean­while, the sin­gle du­laglu­tide and place­bo arms had 52% and 12% of pa­tients hit­ting that tar­get.

Of note, the 15 mg group ac­tu­al­ly saw a high­er per­cent­age (30%) of pa­tients achiev­ing the most im­pres­sive re­duc­tion, which is HbA1c lev­els of less than 5.7% — what you’d ex­pect to see in non-di­a­bet­ics. Among those on the 10 mg dose, 18% got to that point.

But where LY3298176 re­al­ly stood out was in the weight loss num­bers: -4.8 kg (5 mg), -8.7 kg (10 mg) and -11.3 kg (15 mg) while pa­tients on du­laglu­tide shed an av­er­age of -2.7 kg. That trans­lates to more than a third of drug arm pa­tients los­ing 10% or more of their base­line body weight.

Source: Umer Raf­fat

Click on the im­age to see the full-sized ver­sion

Re­searchers are al­so hap­py with the safe­ty pro­file, which they say is “sim­i­lar to the GLP-1 RA class” with the most com­mon­ly re­port­ed side ef­fects be­ing nau­sea, di­ar­rhea and vom­it­ing.

“We set a high bar for this Phase II study, and the re­sults ex­ceed­ed our ex­pec­ta­tions,” said Jeff Em­mick, vice pres­i­dent of prod­uct de­vel­op­ment, Lil­ly Di­a­betes. “We’re ex­cit­ed to con­tin­ue study­ing GIP/GLP-1 RA and hope to add it to our wide range of ther­a­pies for peo­ple with di­a­betes.”

It’s now time to move in­to a larg­er Phase III tri­al dubbed SUR­PASS, which Lil­ly plans to ini­ti­ate by ear­ly 2019 and com­plete in late 2021.

If the da­ta trends hold up — as Raf­fat is bull­ish it would — he sees the drug tak­ing a key po­si­tion in a bi­fur­cat­ing GLP-1 mar­ket:

  • oral se­ma will take lots of share from short-act­ing GLP-1s (where No­vo is al­ready pulling spend from Vic­toza) as well from orals
  • per­haps there will re­main a long-act­ing niche … with No­vo’s Ozem­pic and LLY’s Trulic­i­ty … LLY will like­ly shift the spend away from Trulic­i­ty and over to this GIP/GLP.
Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

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Mil­li­pore­Sig­ma to build new $20 mil­lion, 12,000-square-foot lab in Switzer­land

On the heels of opening a new laboratory in Shanghai last week, MilliporeSigma is continuing its construction push.

The Merck KGgA life science subsidiary announced Wednesday its intentions to build a new $20 million lab in Buchs, Switzerland to support its reference materials business. It’s estimated that the new facility will be completed in December 2021 and open in early 2022 and is expected to be 12,000 square feet.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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