*

Amycretin side-effects similar to other incretin-based

treatments, mainly gastrointestinal

*

Decision on Phase III trial pending subcutaneous study

data next

year

*

Amycretin showed 13.1% weight loss in Phase I trial

(Adds details from conference presentation in paragraphs 1, 4,

6-8, 10)

By Jacob Gronholt-Pedersen and Maggie Fick

COPENHAGEN, Sept 11 (Reuters) - Novo Nordisk

said on Wednesday that its highly anticipated experimental

weight-loss pill amycretin was safe and tolerable for patients

in an early-stage trial, with mild-to-moderate side effects.

The maker of blockbuster drugs Wegovy and Ozempic said in

March that a Phase I trial of the pill version of amycretin

showed participants lost up to 13.1% of their weight after 12

weeks, prompting shares to surge more than 8%.

That compared to weight loss of about 6% after 12 weeks and

15% after 68 weeks in trials of Wegovy.

The company presented full data from the Phase I study at

the European Association for the Study of Diabetes meeting in

Madrid.

"What we see in the study period is a 13.1% weight loss with

a side effect profile comparable to what we normally see with

incretin-based therapy, so primarily gastrointestinal side

effects," Martin Holst Lange, Novo's head of development, said

in an interview ahead of the presentation.

One serious but non-fatal adverse event was reported during

the trial with 60 participants, according to the data presented

at the conference. There were no reports of severe side-effects

for patients taking amycretin, while there were a total of 242

reports of mild and moderate side effects.

Amycretin targets the same gut hormone that Wegovy mimics,

known as GLP-1, but also a pancreas hormone called amylin that

affects hunger.

In the amycretin trial, the side effects were related to

gastrointestinal discomfort, including nausea and vomiting,

similar to those seen in trials of its other medicines from the

same GLP-1 drug class, the company said.

Novo is also developing another two-drug combination

known as CagriSema that also targets the amylin hormone, which

the company has said has a potential of up to 25% weight loss.

"The data that I've seen so far suggests that amycretin

has at least the same weight-loss potential as CagriSema," Lange

said.

In the study, overweight or obese patients without diabetes

received increasing doses of amycretin, starting from 3

milligrams and up to a final dose of two 50 mg pills, Novo said.

Patients who took 50 mg of amycretin at the end of the

12-week trial reduced body weight by 10.4% on average, while

those taking the maximum dose of 2x50 mg lost 13.1% of their

starting weight, the company said. The weight loss did not

plateau by the end of 12 weeks. That compared to an average

weight loss of 1.1% among those taking a placebo.

The data warrants further clinical development, Lange said.

A decision on whether to skip a Phase II trial for amycretin

and proceed directly to phase III - typically the final stage of

human testing before seeking approval - will be taken once data

from an early study on a subcutaneous version of the drug is

ready next year.

Existing obesity drugs like Wegovy and Eli Lilly's ( LLY )

Zepbound are injectable. Pills require larger amounts of active

ingredients, which makes them more costly to produce but are

often favoured by patients.

Novo's shares have increased more than three-fold since June

2021, when it launched Wegovy in the United States, but have

shed 15% since peaking in June this year.

Around 40% of Novo's valuation is pinned to its pipeline of

experimental drugs, analysts at Berenberg said last week.

Last year, Novo become Europe's most valuable listed

company, ahead of LVMH.