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Novo Nordisk (NVO) Up on Upbeat Data From New Obesity Pill Study

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Novo Nordisk (NVO - Free Report) shares climbed about 9% on Mar 7 and continued to gain another 1.4% in the after-market hours, following the company’s presentation of efficacy data from a phase I study on its new oral obesity pill, amycretin, at its Capital Markets Day.

In the completed phase I study of oral amycretin, it was observed that the treatment of patients with amycretin resulted in a reduction of 13.1% in body weight compared with a decrease of 1.1% in the placebo arm after 12 weeks. Amycretin has shown faster weight loss than Wegovy (semaglutide 2.4 mg), a GLP-1 agonist. Wegovy showed a weight loss of about 5-6% in a mid-stage study over the same time period.

The greater efficacy observed in the case of oral amycretin compared with Wegovy is expected due to the differences in the mechanisms of action of the drugs. Wegovy only targets a hormone called GLP-1 to trigger weight loss. However, amycretin targets GLP-1, as well as a second hormone called amylin. Notably, Amylin originates in the pancreas and is responsible for reducing food intake by delaying stomach emptying, as well as decreasing blood glucose levels, leading to the reduction of body weight.

A separate phase I study on a subcutaneous formulation of amycretin is also currently ongoing and is expected to be completed in 2025.

Wegovy is Novo Nordisk’s blockbuster chronic weight management injection approved for adults with obesity or overweight. The drug received FDA approval in 2021 and has been witnessing solid uptake ever since, driven by increasing demand worldwide. In 2023, Wegovy generated sales worth DKK 31.3 billion, representing year-over-year growth of 407% on a reported basis and 420% at a constant exchange rate.

In the past year, shares of Novo Nordisk have rallied 92.1% compared with the industry’s 34.5% growth.

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The obesity market has garnered much interest in 2023, ever since Novo Nordisk received FDA approval for Wegovy. Biotech firms have been competing fiercely throughout 2023 to enter the obesity market due to the huge untapped market opportunity that it represents amid increasing demand.

Other companies like Eli Lilly (LLY - Free Report) , Viking Therapeutics (VKTX - Free Report) and Amgen (AMGN - Free Report) have their own obesity management drugs, already marketed or under investigation, which target more than one hormone to trigger weight loss.

Eli Lilly received FDA approval for tirzepatide under the brand name Mounjaro, a dual GIP and GLP-1 receptor agonist, in 2022 to treat adults with type II diabetes. In November 2023, Lilly received FDA approval for the same tirzepatide formulation, under the brand name Zepbound, for chronic weight management in adults with obesity or overweight.

Since its launch, Mounjaro has shown an impressive initial uptake. Approval of the obesity indication is expected to help LLY rake in billions of dollars from tirzepatide sales.

Viking Therapeutics is also currently evaluating a subcutaneous formulation of its investigational candidate, VK2735, in a mid-stage study and an oral formulation of VK2735 in a separate early-stage study. Like Eli Lilly’s tirzepatide, VK2735 is also a dual GIP and GLP-1 receptor agonist.

Last month, VKTX reported that the phase II study of subcutaneous VK2735 achieved its primary and all secondary endpoints, demonstrating statistically significant reductions in body weight upon treatment with the candidate compared with placebo. Patients treated with VK2735 achieved a placebo-adjusted reduction in body weight of up to 13.1% after 13 weeks. Please note that Novo Nordisk achieved the same percentage reduction after 12 weeks of treatment with amycretin.

It is important to note that in the last trading session, Viking Therapeutics shares lost almost 19% after Novo Nordisk presented encouraging data on amycretin as investors may have speculated that amycretin has a greater potential to outperform VK2735, both having reported similar efficacy results. Oral amycretin is also an easier-to-use formulation compared with subcutaneously injected VK2735.

Amgen is also currently evaluating two investigational candidates, maridebart cafraglutide and AMG 786, in a phase II study and a phase I study, respectively, for the obesity indication. Out of these two candidates, maridebart cafraglutide is particularly intriguing, having a unique mechanism of action. This investigational drug activates the GLP-1 receptor and inhibits the GIP receptor.

Zacks Rank

Novo Nordisk currently carries a Zacks Rank #3 (Hold).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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