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Biotech


NOVO OBESITY PROSPECT LINKED TO ‘MILD TO MODERATE NEUROPSYCHIATRIC SIDE EFFECTS’
IN PHASE 2

By James Waldron Sep 20, 2024 10:25am
Novo Nordisk Obesity weight loss Clinical Data

The neuropsychiatric side effects inclluded anxiety, irritability and sleep
disturbances. (Pogonici/iStock/Getty Images Plus)

Novo Nordisk’s $1 billion bet that it had found a cannabinoid CB1 receptor
blocker that could reduce weight while avoiding the psychiatric effects that
capsized Sanofi’s Acomplia faces questions after the company revealed mid-stage
headline results.

The Danish Big Pharma gained its CB1 receptor blocker, now known as monlunabant,
as part of the acquisition of Canada’s Inversago in a vague deal that Novo
described at the time as being worth “up to” $1.07 billion inclusive of
milestone payments.







Announcing the deal in August of 2023, Novo said monlunabant had already
demonstrated weight loss in a phase 1b trial. But the fresh push into the CB1
modality brought back memories of Sanofi’s Acomplia, which was withdrawn from
the European market by regulators in 2009 after studies linked the drug to a
doubling of the risk of psychiatric disorders. The product never won approval in
the U.S.















In this morning’s readout from Novo's phase 2 trial of monlunabant in 243 people
with obesity and metabolic syndrome, it seems the CB1 receptor blocker may face
some familiar problems.



“Reporting of mild to moderate neuropsychiatric side effects, primarily anxiety,
irritability, and sleep disturbances, was more frequent and dose-dependent with
monlunabant compared to placebo,” Novo acknowledged in the Sept. 20 release.







The company stressed that “no serious adverse events were reported in relation
to neuropsychiatric side effects.”

The most common adverse events were gastrointestinal, the pharma noted, with
“the vast majority being mild to moderate and dose-dependent.”


RELATED

Novo Nordisk bets $1.1B on Canadian biotech buyout, adding an old approach to
obesity pipeline

The weight loss shown by monlunabant, while “statistically significant,” was
also nothing special considering the current treatment landscape. The lowest
once-daily dose, at 10 mg, achieved a reduction in body weight of 7.1 kg over 16
weeks from a baseline weight of 110.1 kg—equivalent to a weight loss of 6.4%.

While it’s important to be cautious of like-for-like comparisons of separate
trials, a 2.4 mg dose of Novo’s blockbuster obesity drug Wegovy has been shown
to induce 5% weight loss after just 12 weeks. That drug is given as an
injection, whereas an oral option could be viewed as a favorable alternative for
many with obesity.



The company has another oral bet. Earlier this month, Novo showed that its
amylin and GLP-1 receptor co-agonist had produced 13.1% weight loss in 12 weeks.

Novo noted in this morning’s release that the higher doses of monlunabant it
evaluated, namely 20 mg and 50 mg, only induced “limited additional weight loss”
over the 10 mg dose.


RELATED

Novo Nordisk hails ‘remarkable’ weight loss result for dual-acting oral drug in
early trial

While the uninspiring weight loss numbers coupled with neuropsychiatric side
effects may appear to put a dent into Novo’s post-Wegovy obesity strategy, the
company was clear in the release that it will continue to evaluate the CB1
blocker. A larger phase 2b obesity trial is slated to begin next year and will
assess “the safety profile of monlunabant over a longer duration in a global
population.”

“The phase 2a results indicate the weight-lowering potential of monlunabant and
that further work is needed to determine the optimal dosing to balance safety
and efficacy,” Martin Holst Lange, EVP and Head of Development at Novo,
explained in the release.

“Obesity is a complex disease with a significant unmet need, and as an oral
small molecule having a new mechanism of action, monlunabant is one of the novel
projects in our pipeline with the potential of treating obesity,” he added.

The pharma's stock had dropped 5.7% to $127.10 as of 10:25 am ET on Friday
morning.





Novo Nordisk Obesity weight loss Clinical Data Biotech
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