AbbVie's ABBV-951 Demonstrates Superior Efficacy Over Oral Levodopa/Carbidopa in Phase 3 Trial for Advanced Parkinson’s Disease

October 28, 2021 /BioonBIOON/ -- AbbVie recently announced positive data from the Phase 3 M15-736 study (NCT04380142), a head-to-head superiority comparison. This was a randomized, double-blind, double-dummy, active-controlled study conducted in patients with advanced Parkinson's disease (PD), who were randomized into two groups, one of which receivedContinuous 24-hour/day subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa), the other group receivedOral levodopa/carbidopa (levodopa/carbidopa, LD/CD), treated for 12 weeks. Primary endpoint of the study: the increase from baseline in "ON" time (hours) without troublesome dyskinesia (involuntary movements) after 12 weeks of treatment, based on motor status assessed by the Parkinson's Disease Diary (PD Diary).

The results show that theThe study met its primary endpoint: ABBV-951 was statistically superior to oral LD/CD in reducing motor fluctuations in patients with advanced PD.The specific data are as follows: At 12 weeks of treatment, “ON” time increased by 2.72 hours in the ABBV-951 treatment group, compared with an increase of 0.97 hours in the oral LD/CD treatment group (p=0.0083). Improvement in “ON” time was observed in the ABBV-951 treatment group as early as week 1 and was sustained through week 12.

Additionally,A similar pattern of improvement from baseline in mean daily standardized "OFF" time was also observed.. Compared with the oral LD/CD treatment group, improvement in "OFF" time was observed in the ABBV-951 treatment group as early as Week 1 and sustained through Week 12. Specifically, after 12 weeks of treatment, "OFF" time decreased by 2.75 hours in the ABBV-951 treatment group compared with a reduction of 0.96 hours in the oral LD/CD treatment group (p=0.0054).

In this study, most adverse events (AEs) reported in the ABBV-951 group were non-serious and mild to moderate in severity. The incidence of serious adverse events was 8% in the ABBV-951 group and 6% in the oral LD/CD group. One patient in the oral LD/CD group died due to a treatment-emergent adverse event (TEAE), whereas no deaths occurred in the ABBV-951 group. The most commonly reported AEs (≥5%) in the ABBV-951 group were infusion site AEs (erythema, pain, cellulitis, edema, bruising, bleeding, nodules, induration, infection, and pruritus), dyskinesia, “ON” and “OFF” phenomena, falls, hallucinations (including visual hallucinations), balance disorders, constipation, and peripheral swelling. The incidence of infusion site AEs was higher in the ABBV-951 group than in the oral LD/CD group; most were non-serious and mild to moderate, resolved with or without treatment, and none resulted in systemic complications. The incidence of hallucinations and psychiatric AEs was higher in the ABBV-951 group compared with the oral LD/CD group. These events were mild to moderate in severity. Compared with the oral LD/CD group, the incidence of falls and related injuries was lower in the ABBV-951 group. AEs led to discontinuation of study treatment in 21.6% of patients in the ABBV-951 group and 1.5% of patients in the oral LD/CD group.

The results of this study will constitute a key component of the global regulatory submissions for ABBV-951. Detailed data will be presented at upcoming medical...Conferencepublished on, or submitted for publication in a peer-reviewed journal. Michael Severino, Executive Vice President and President of AbbVie, stated: “Parkinson’s disease is a progressive, irreversible neurological disease with debilitating symptoms that can make daily life challenging. We are committed to meeting the ongoing needs of patients, and we are encouraged by these results, which highlight the potential of ABBV-951 to provide an alternative treatment option for patients with advanced Parkinson’s disease.” (Bioon.com)

Original Source: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