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

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.

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