AEON Biopharma has reported positive topline data from its Phase II clinical trial of ABP-450 (prabotulinumtoxinA) to treat cervical dystonia (CD).
The double-blind, randomised, placebo-controlled trial evaluated 57 subjects at 20 US sites.
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Subjects were categorised into four cohorts to receive either a low dose (150 units), mid-dose (250 units), or high dose (350 units) of ABP-450 or a placebo.
They were then followed up for 20 weeks, with the primary efficacy endpoint evaluated at four weeks following dosing.
According to the findings, the trial met the primary and secondary endpoints, with statistical significance in lowering CD-linked signs and symptoms in adults.
All three tested doses of ABP-450 were demonstrated to be generally safe and well tolerated.
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By GlobalDataThe treatment’s adverse event rates were in line with, or less than, other botulinum toxin products for treating cervical dystonia.
In the trial, mild or moderate treatment-related adverse events were observed, without any serious adverse events.
ABP-450 is a botulinum toxin complex. It comprises a bacterium Clostridium botulinum-produced 900 kDa botulinum toxin type-A complex.
The therapy is licenced from Daewoong Pharmaceutical and AEON holds the exclusive development and supply rights of ABP-450 for therapeutic indications in some territories, including the US, Canada, and the European Union, among others.
AEON Biopharma president and CEO Marc Forth said: “We’re pleased to announce the topline data from the Phase II of ABP-450, as we continue to develop prabotulinumtoxinA injection for treatment of debilitating medical conditions, including cervical dystonia.
“These overwhelmingly positive data confirms that ABP-450 has a therapeutic profile that is consistent with, or exceeds, that of other botulinum toxin products and gives us renewed confidence in our other indications for migraine prevention and treatment of gastroparesis.”
The company plans to hold an end-of-Phase II meeting with the US Food and Drug Administration in the first quarter of next year.
AEON also intends to begin the Phase III programme for CD next year.
A chronic and debilitating neurologic condition, CD impacts the neck muscles.
