Eli Lilly is rapidly approaching its Trulicity doomsday, but it may have a nice consolation prize in tirzepatide – Endpoints News

As the hourglass begins to run out on blockbuster Trulicitys US patent, Eli Lilly may find a successor in tirzepatide its GIP and GLP-1 receptor agonist that has turned up yet another round of promising data.

Tirzepatide significantly reduced the blood sugar and body weight of patients with type 2 diabetes, according to topline results from the pharmas Phase III SURPASS-1 trial. The results build on mid-stage data from 2018 which showed the drug beat out both a placebo and Trulicity in terms of blood sugar reduction and weight loss. Lillys stock $LLY jumped more than 4% on the news Wednesday morning, with shares pricing at $155.74 apiece.

In total, 478 type 2 diabetes patients were randomized to receive one of three doses of tirzepatide or a placebo once weekly over 40 weeks. All participants in the treatment arm started out with a 2.5 mg dose, which was increased in incremental steps to a final maintenance dose of either 5 mg, 10 mg or 15 mg. Nearly 90% of patients achieved an A1C, a measure of blood sugar, of less than 7%, the American Diabetes Associations recommended target for people with the illness, according to SURPASS-1 principal investigator Julio Rosenstock. And more than half of patients on highest dose had an A1C of less than 5.7% the level seen in people without diabetes, the company announced.

Those on the 5mg dose had a 1.87% A1C reduction from a baseline of 7.9%, according to Lilly, compared to a 1.89% reduction for the 10 mg group, a 2.07% for the 15 mg group and a 0.04% increase for the placebo group. Those in the highest dose group had an 11.0% weight reduction from the 85.9 kg baseline, compared to a 0.9% reduction in the placebo group.

Just over 54% of patients in the study were treatment-nave, with a mean duration of diabetes of 4.7 years. All of the patients were nave to injectable therapy and hadnt used any oral antidiabetic medicines in three months prior.

No events of severe hypoglycemia or hypoglycemia less than 54 mg/dL were observed in the tirzepatide treatment arms, Lilly said in a statement.

The most commonly reported adverse events were gastrointestinal-related and mild to moderate in severity, according to the pharma. The most common ones were nausea, diarrhea, vomiting and constipation.

We are impressed by these initial results showing how tirzepatide performed in people with a relatively short duration of diabetes, and we look forward to seeing more results in people who are later in the course of diabetes in future studies from our robust SURPASS clinical trial program, Lilly Diabetes president Mike Mason said in a statement.

Tim Anderson, a senior analyst at Wolfe research, wrote in a note that tirzepatide has the potential to be an upgrade to Trulicity and other GLP1s on the market, including Novo Nordisks.

Sell-side consensus already has a whopping ~$5B in risk-adjusted sales in a distant out-year for the product (a very high figure for a product where no ph3 data has yet been shown). Our forecast in 2030 is $5.2B (not risk-adjusted). A regulatory filing is likely in 2H-2021, with approval/launch sometime in 2022.

Trulicity, which is protected by a compound patent in the US until 2027, earned Eli Lilly $4.12 billion in net sales in 2019.

Back in January, the FDA endorsed Novo Nordisks blockbuster rival Ozempic for its ability to reduce the risk of major adverse cardiovascular events. Like other GLP-1 treatments, Ozempic is designed to stimulate insulin production. Another popular class of diabetes drugs, SGLT2 inhibitors, work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination. Players here include Invokana from J&J, Jardiance from Eli Lilly and Farxiga from Boehringer Ingelheim and AstraZeneca.

In March, the FDA handed a CRL to Eli Lilly and Boehringer Ingelheim, squashing their attempt at expanding the best-selling SGLT2 inhibitor Jardiance to type 1 diabetes.

Eli Lilly says the full SURPASS-1 data will be read out at the annual Scientific Sessions of the American Diabetes Association, and published in a peer-reviewed journal in 2021.

Read more:

Eli Lilly is rapidly approaching its Trulicity doomsday, but it may have a nice consolation prize in tirzepatide - Endpoints News