Skip to main content
On Our Radar

KM-819 for the Treatment of Parkinson’s Disease Demonstrates Favorable Safety Profile in Healthy Adults

By February 7, 2023No Comments

KM-819 for the Treatment of Parkinson’s Disease Demonstrates Favorable Safety Profile in Healthy Adults

The California-based drug development company FAScinate Therapeutics, Inc. announced positive results from the first part of a Phase 2 trial of KM-819, a compound being tested for the treatment of Parkinson’s disease.

KM-819 inhibits FAS-associated factor one (FAF1), a protein that plays a role in programed cell death and is associated with the accumulation of alpha-synuclein. In previous cell and animal studies, KM-819 protected dopaminergic cells and prevented alpha-synuclein from accumulating.

In part 1a of the Phase 2 trial, three dosage strengths of KM-819 demonstrated a favorable safety profile compared to placebo in healthy adults. Part 1b will evaluate the safety and pharmacokinetics of 200 mg, 400 mg, and 600 mg of KM-819 vs placebo in patients with Parkinson’s disease. Results will be used to determine the optimal dosage for study in part 2 of the Phase 2 trial, which will randomly assign patients with Parkinson’s disease to KM-819 or placebo for two years. Effectiveness will be evaluated using the Unified Parkinson’s Disease Rating Scale-Part 2: Activities of Daily Living.

In a press release, FAScinate Therapeutics stated “We are pleased with the prospects of KM-819 as a disease-modifying treatment for Parkinson’s disease as we progress through Phase 2 trials. Part 1a showed favorable safety even at very high doses, and we are excited to now initiate Part 1b. KM-819 shows great promise when it comes to the neuroprotection of dopaminergic cells, including GBA mutation, as well as in clearing alpha-synuclein.” The company also plans to test KM-819 for the treatment of multiple system atrophy.

Read more from the press release

CND Life Sciences

CND Life Sciences is the creator of the Syn-One Test™, the world’s first commercially available test to visualize abnormal, phosphorylated alpha-synuclein in cutaneous nerve fibers. The test is an objective, evidence-based diagnostic tool to aid in the diagnosis of Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, or REM sleep behavior disorder.