Kainos Medicine Reaches Milestone in bringing “KM-819” Treatment for Parkinson‘s Disease to Market
Completion of Phase 1 Clinical Study Demonstrates Safety and Tolerability of KM-819 Drug Candidate
SEONGNAM, South Korea, Jan. 7, 2019 /PRNewswire-PRWeb/ -- Kainos Medicine Inc. today announced that it has completed Phase 1 clinical trials of its Parkinson's Disease drug candidate, code-named "KM-819." KM-819 is an orally active small molecule that is a potentially disease-modifying treatment of Parkinson's Disease. The trial took place in South Korea.
This Phase 1 randomized, double-blind, placebo-controlled dose-escalation study was to evaluate the safety, tolerability, and pharmacokinetics as well as various pharmacodynamics markers of KM-819 in healthy volunteers. The study was divided into Part A (Single Ascending Dose) and subsequently Part B (Multiple Ascending Dose), a total of 88 people including 2 groups of 16 elderly.
Results showed KM-819 demonstrated a promising positive safety and well-tolerability without no drug-related serious adverse events. And it showed desirable pharmacokinetic characteristics with dose-dependent exposure, and very interestingly more than two times higher exposure in elderly groups (over 60 years old) than young groups (less than 40 years old).
KM-819 has shown superior efficacy in neuroprotection in cell models, and in dopaminergic neuron protection in the midbrain of various animal models of Parkinson's disease as well as improvement in behavioral tests, suggesting the drug has the potential capability of slowing or stopping the progression of Parkinson's Disease.
Additional trial details and updates can be found at http://www.clinicaltrials.gov.
About KM-819 KM-819 is a small molecule developed as an inhibitor for FAF1, a proapoptotic protein, designed to target various degenerative diseases. It has shown superior neuroprotective efficacy in Parkinson's disease models, and recently completed the clinical trial phase 1 for safety, tolerability and pharmacokinetic characteristics, aiming to prove its efficacy in stopping the disease in human patients. The efficacy of KM-819 may be also explored for other degenerative diseases.
About Parkinson's Disease Parkinson's Disease is a very common disease of the Central Nervous System (CNS), second only to Alzheimer Disease in the number of people diagnosed with an estimated 6 to 10 million patients worldwide, 1 million of whom are in the United States. It is more common in elderly people and affects 2-3% of those aged 65 and over, with an increase expected as the population continues to age. The current standard of care is limited to supportive symptom management with supplemental dopamine or dopamine agonists or analogous mechanisms; a disease modifying treatment is one of the most urgent needs in order to counter the otherwise inevitably growing impact of Parkinson's Disease.
About Kainos Medicine Inc. Kainos Medicine Inc. Inc. is a clinical stage biotechnology company based in South Korea, focused on the discovery and early development of novel therapeutics for central nervous system diseases, cancer and viral diseases. Kainos Medicine has established research to identify promising drug candidates and has successfully initiated clinical studies for several, including KM-819 for Parkinson's Disease.
For more information, please visit http://www.kainosmedicine.com
Forward-Looking Statements This press release contains forward-looking statement. These statements relate to, among other things, potential of KM-819 as a disease-modifying therapeutics including stopping or slowing the progression of the Parkinson's disease. These statements are identified by their use of terms and phrases such as "will", "potentially", "suggest". "targeting", "expect", "aiming", "prove", "explore", "estimated" and other similar terms and phrases. These statements are based on estimates, assumptions, and projections that may not prove to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties, and other factors. Kainos Medicine undertakes no obligations to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Kainos Medicine's expectations.
SOURCE Kainos Medicine Inc.