AbbVie’s bid to cannibalize its own Parkinson’s disease business has advanced, with the phase 3 success of subcutaneous, pump-delivered levodopa-carbidopa formulation ABBV-951 providing the backbone of planned approval filings.
The 12-week, 130-subject phase 3 trial pitted ABBV-951 against oral levodopa-carbidopa. Subjects on ABBV-951 experienced a 2.7-hour increase in “On” time, when symptoms are well controlled, versus a one-hour improvement in the oral control cohort. The improvement was evident after one week and persisted throughout the study.
ABBV-951 consists of levodopa and carbidopa prodrugs that are delivered by a pump. After delivery into the subcutaneous space, the prodrug foslevodopa is converted to the active levodopa. AbbVie has focused on maximizing the solubility and concentration of the prodrugs to make it practical to deliver lower dose volumes via a small pump.
The candidate is designed to fill a gap in the Parkinson’s treatment toolkit. Oral levodopa is still a mainstay of Parkinson’s care, but its short half-life of and the narrowing of the therapeutic window mean it ultimately fails to control symptoms.
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AbbVie previously developed Duodopa to overcome the short half-life of levodopa. Duodopa delivers a continual stream of levodopa and carbidopa into the intestines to supply steadier levels of the drugs and improve daily “on” and “off” times. However, delivery of Duodopa requires the surgical implantation of a tube, which carries ongoing risks and limits uptake. Even so, the product generated $383 million for AbbVie over the first nine months of the year. ABBV-951 could do more business.
“There's only a subset of patients who are either willing or able to with their caregivers manage that situation [with Duodopa]. Now, those patients get great results. But with something like ‘951, we can broaden the population that will be able to use the device and willing to use the device,” Michael Severino, president of AbbVie, said at an investor event earlier this year.
Tolerability will be a focal point as AbbVie rolls out more data on ABBV-951. AbbVie saw infusion site adverse events in the study, but said most of them were mild to moderate in severity. All of the reactions were resolved and none led to systemic complications.
AbbVie’s data landed before results on NeuroDerm’s rival subcutaneous Parkinson’s prospect. A phase 3 clinical trial of NeuroDerm’s candidate, ND0612, is scheduled to hit its primary completion next summer, according to ClinicalTrials.gov.