AbbVie's Innovative Subcutaneous Infusion Therapy ABBV-951 Meets Primary Endpoint in Phase 3 Trial, Overcoming Limitations of Oral Parkinson’s Disease Treatments

On October 28, 2021, AbbVie announced that the investigational Parkinson’s disease therapy ABBV-951 (foslevodopa/foscarbidopa) met its primary endpoint in a pivotal Phase 3 clinical trial. The trial results demonstrated that, compared with oral levodopa/carbidopa, continuous 24-hour subcutaneous infusion of ABBV-951 significantly improved motor fluctuations in patients with advanced Parkinson’s disease. These results will form a key component of the regulatory applications to be submitted to global regulatory authorities.

Parkinson’s disease is a progressive neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine. The decline in dopamine levels in the brain leads to a wide range of motor and non-motor symptoms. Since the 1970s, the primary treatment for patients has been levodopa. However, over time, levodopa may cause involuntary and uncontrolled movements, known as dyskinesia.

In advanced-stage patients, oral levodopa faces multiple challenges, such as impaired gastrointestinal function delaying timely drug absorption and the inability of oral administration to maintain stable plasma drug concentrations, which further exacerbates motor complications.

ABBV-951 is a prodrug of levodopa and carbidopa. It is highly water-soluble and can be administered via continuous subcutaneous infusion using a pump connected to subcutaneous tissue, thereby maintaining stable systemic drug concentrations.

This randomized, double-blind, active-controlled Phase 3 clinical trial enrolled approximately 130 adult patients with advanced disease. The primary endpoint was "Good On" time, defined as "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia.

The trial results demonstrated that at Week 12, the ABBV-951 group experienced an increase of 2.72 hours in "Good On" time, compared with an increase of 0.97 hours in the oral medication group (p = 0.0083). Furthermore, an improvement in patients' "Good On" time was observed in the ABBV-951 group as early as Week 1 and was sustained throughout the 12-week treatment period. Additionally, the trial observed an improvement from baseline in the mean troublesome "Off" time for the ABBV-951 group. After 12 weeks of treatment, "Off" time decreased by 2.75 hours in the ABBV-951 group and by 0.96 hours in the oral medication group (p = 0.0054).

In terms of safety, most adverse events (AEs) in the ABBV-951 group were mild to moderate in severity, with a serious AE incidence of 8% compared to 6% in the oral medication group. AEs led to treatment discontinuation in 21.6% of patients in the ABBV-951 group and 1.5% in the oral medication group. The full results of the Phase 3 clinical trial will be presented at future medical conferences and submitted for publication in peer-reviewed journals.

References:

[1] AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease. Retrieved October 28, 2021, from https://news.abbvie.com/news/press-releases/abbvie-announces-abbv-951-foslevodopafoscarbidopa-showed-improvement-in-controlling-motor-fluctuations-compared-to-oral-levodopacarbidopa-medication-in-pivotal-phase-3-trial-in-patients-with-advanced-parkinsons-disease.htm

(Original text abridged)

▽Follow【WuXi AppTecVirtue】WeChat Official Account