FAScinate Therapeutics Inc. Submits Investigational New Drug (IND) Application for Phase 2 Clinical Studies of Company's New Parkinson's Disease Treatment

Company Aims to Evaluate Safety, Tolerability, and Preliminary Efficacy of New Drug Candidate "KM-819"



FAScinate Therapeutics today announced that it has submitted an Investigational New Drug (IND) Application for Phase 2 clinical trials of its Parkinson's Disease drug candidate "KM-819" to the U.S. Food and Drug Administration (FDA). KM-819 is an orally active small molecule that is a potentially disease-modifying treatment for Parkinson's Disease.

This Phase 2 randomized, double-blind, placebo-controlled study is divided into Party 1a and 1b (dose finding study in healthy elderly patients and patients with Parkinson's Disease, respectively) and part 2 (two ascending doses in patients Parkinson's Disease) for the evaluation of the safety, tolerability, and pharmacokinetics and preliminary efficacy of KM-819 in healthy older adults and in participants with Parkinson's Disease.

KM-819 has already shown superior efficacy of neuroprotection in cell models and of dopaminergic neuron protection in the midbrain in various animal models of Parkinson's disease, as well as improvement in behavioral tests, strongly suggesting this drug has the potential to slow or even stop the progression of Parkinson's Disease.

About KM-819
KM-819 is a small molecule developed as an inhibitor for FAF1, a proapoptotic protein, targeting various degenerative diseases. It has shown a superior neuroprotective efficacy in Parkinson’s Disease models, entered in clinical trials with the aim of proving efficacy in human patients. KM-819 may be also explored in other indications for different degenerative diseases including multiple system atrophy (MSA). It shows an excellent safety profile in both long-term animal toxicology studies and the human clinical trial phase 1 study.

About Parkinson’s Disease
Parkinson’s Disease is the second most common chronic CNS disease, next to Alzheimer’s Disease, estimated to afflict 6 to 10 million patients worldwide and 1 million in the United States. It is more common in elderly people, with 2-3 % aged 65 and over now affected, and an expectation of an increase in the number of patients as the population continues to age. The current standard of care is symptomatic treatments by supplementing dopamine or dopamine agonists or analogous mechanisms, and the disease modifying treatment is one of the major unmedical needs to block the progression.

About FAScinate Therapeutics Inc.
FAScinate Therapeutics Inc., a subsidiary of the Korean Biotech company Kainos Medicine Inc., is a clinical stage biotechnology company based in San Diego, California focused on the development of novel therapeutics for central nervous system diseases. FAScinate has licensed KM-819 for clinical development and commercialization from Kainos Medicine, and is moving it to phase 2 study in the US for Parkinson’s Disease. For more information, please visit http://www.fascinatetherapeutics.com

Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the potential of KM-819 as a disease-modifying therapeutic stopping or slowing the progression of Parkinson’s disease. These statements are identified by their use of terms and phrases such as “will,” “potentially,” “suggest,” “targeting,” “expect,” “aiming,” “prove,” “estimated,” and other similar terms and phrases. These statements are based on estimates, assumptions, and projections that may not be proven to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties, and other factors. FAScinate Therapeutics 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 FAScinate Therapeutics’s expectations.

FAScinate Therapeutics Inc. Submits Investigational New Drug (IND) Application for Phase 2 Clinical Studies of Company's New Parkinson's Disease Treatment