Phase 2a study results in binge eating disorder
Allschwil, Switzerland – May 1 0 , 20 2 2
Idorsia Ltd (SIX: IDIA) today announced that ACT-539313, a selective orexin-1
receptor antagonist, did not show an improvement over placebo in reducing the
number of binge eating days per week in adult patients with moderate to severe
binge eating disorder – the primary endpoint was therefore not met. ACT-539313
was very well tolerated over the treatment period of 12 weeks.
Alberto Gimona, Head of Global Clinical Development of Idorsia , commented:
“Assessing pharmaceutical intervention in disorders such as binge eating, when
we target modification of the behaviors underpinning the disorder is very
challenging. The result is obviously disappointing for the team and
investigators who flawlessly executed the study, and of course for the patients
affected by this disorder. The study confirmed the encouraging safety profile
seen in the pharmacology studies, but it is clear that we will not pursue the
binge eating disorder indication.”
The company will now fully analyze the data and publish the results of the
study in scientific literature in due course.
Notes to the editor
About the Phase 2 study
In the study, 136 patients were randomized to receive either ACT-539313 at a
dose of 100 mg twice daily, or placebo in a 1:1 ratio over a 12‑week treatment
period. The primary efficacy endpoint was the change from baseline to Week 12
in the number of binge eating days per week. A binge eating day was defined as
a day with at least one confirmed binge eating episode. The study also assessed
the effect of ACT-539313 in modulating behavioral features that contribute to
the psychopathology in BED, in addition to reducing the frequency of binge
eating.
About ACT-539313
ACT-539313 is a potent, brain-penetrating, selective orexin 1 receptor
antagonist. Preclinical studies have shown that orexins play a role in driving
compulsive binge-like consumption, and ACT-539313 reduced binge-like eating
behavior in animal models.
In the Phase 1 studies, ACT-539313 was well tolerated at single oral doses of
up to and including 400 mg and at multiple oral doses of up to and including
200 mg twice daily for 10 days in healthy volunteers.
About Idorsia
Idorsia Ltd is reaching out for more – We have more ideas, we see more
opportunities and we want to help more patients. In order to achieve this, we
will develop Idorsia into a leading biopharmaceutical company, with a strong
scientific core.
Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is
specialized in the discovery, development and commercialization of small
molecules to transform the horizon of therapeutic options. Idorsia has a broad
portfolio of innovative drugs in the pipeline, an experienced team of
professionals covering all disciplines from bench to bedside, state-of-the-art
facilities, and a strong balance sheet – the ideal constellation to translate
R&D efforts into business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June
2017 and has over 1,200 highly qualified specialists dedicated to realizing our
ambitious targets.
For further information, please contact
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com
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Anhang Medienmitteilung PDF
