COMPLETED: Risvodetinib (ABLi-148009)-101 ("the 101 Trial")

This Phase 1/1b study investigated the safety and tolerability of the drug Risvodetinib (ABLi-148009) in healthy elderly volunteers (55 to 70 years old) and in Parkinson’s disease patients.

Learn more about the 101 Trial

COMPLETED: Risvodetinib (ABLi-148009)-201 (“the 201 Trial”) in Parkinson’s disease

This Phase 2 study is investigating the safety and tolerability of Risvodetinib (ABLi-148009) at three doses for 12 weeks in 120 untreated Parkinson’s disease patients who do not currently take any medications to control their disease. Thirty-two sites in the U.S. are participating in this study. The study is expected to be extended for an additional 12 months following the 12-week double-blinded period.

Learn more about the 201 Trial

PLANNED: Risvodetinib (ABLi-148009)-202 (“the 202 Trial”) in Multiple Systems Atrophy

This is a Phase 2/3, double-blind, multi-center, randomized, placebo controlled trial of two Risvodetinib doses in participants with MSA designed to assess Risvodetinib safety, tolerability, PK, and efficacy on disease progression. Secondary and exploratory endpoints will evaluate the change in additional clinical features and biomarkers of disease severity and/or progression in the presence or absence of Risvodetinib. It will be conducted in up to 35 sites across the European Union (EU) and the United States (US).

PLANNED: Risvodetinib (ABLi-148009)-303 in Parkinson’s disease (Open Label)

This is an Open Label study that plans to enroll the 120 participants from the 201 Trial into a 12-month open label study with random assignment to one of two active doses. All 201 Trial participants that continue to meet trial criteria will be eligible, irrespective of whether they have initiated symptomatic therapy. The OL Trial will evaluate relative changes in individual functional assessments in motor and non-motor function and perform detailed analysis of pathological synuclein status using mandatory biomarker assessments using skin biopsy, blood-borne biomarkers, cerebrospinal fluid and novel imaging of alpha-synuclein aggregates in the brain. It will be conducted in up to 32 sites across the United States (US).

PLANNED: Risvodetinib (ABLi-148009)-301 in untreated Parkinson’s disease: C-Abl Modification of Parkinson’s disease (CAMPD)

This is a two-dose, placebo-controlled double-blind study of approximately 450 untreated participants within 3 years of a Parkinson’s diagnosis. CAMPD will evaluate the efficacy of risvodetinib using a novel primary endpoint that measures the ability of risvodetinib to slow or halt disease progression by measuring changes in the rate of clinical worsening. Secondary measures will evaluate whether risvodetinib improves the ability of participants to function better in their daily lives (known as the Activities of Daily Living), improves gastrointestinal function and will evaluate the treatment effect on the underlying process of neurodegeneration, including clearance of alpha-synuclein protein aggregate pathology. The potential for recovery of dopamine signaling is also going to be assessed using DAT-SPECT. Those that successfully complete the 301 Trial will be offered the opportunity to participate in the 303 Trial (Open Label) provided they continue to meet the eligibility criteria, and their study physician feels its appropriate for them to participate.