– IKT-148009 is a mechanistically defined disease-modifying therapy –
ATLANTA–(BUSINESS WIRE)–Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, today announced dosing of the first patients in its Phase 1 clinical trial of IkT-148009, an Abelson Tyrosine Kinase, or c-Abl, inhibitor for the treatment of Parkinson’s disease.
This randomized Phase 1 study is investigating the safety, tolerability and pharmacokinetics (PK) of IkT-148009 in healthy volunteers aged 45 to 70 years old with the objective of identifying the maximum tolerated dose and the PK profile of IkT-148009 in single and multiple ascending dose settings. In preclinical animal models of progressive disease, the Company demonstrated that once a day oral therapy with IkT-148009 can both halt and reverse functional loss in the brain and gastrointestinal tract.
“The initiation of our Phase 1 study of IkT-148009 for the treatment of Parkinson’s disease represents a significant milestone for Inhibikase. Based on preclinical data, we believe that c-Abl plays a critical role in the Parkinson’s disease process and inhibition of c-Abl represents a promising new approach to disease modification,” stated Milton Werner, Ph.D., Chief Executive Officer of Inhibikase Therapeutics. “We are excited to advance into the clinic, and believe that IKT-148009 could be a transformative therapy for millions of patients worldwide.”
Activation of c-Abl, in humans occurs once plaques of alpha-synuclein are internalized by the affected neurons. C-Abl then drives biochemical pathways and processes that lead to degradation of the neurons affected in Parkinson’s disease. Inhibition of c-Abl may restore functional loss for neurons that have not fully degraded in the brain and remodel neurons in the gastrointestinal tract, two major organ systems affected by the disease.
About Parkinson’s Disease
Parkinson’s disease (PD) is the second most prevalent neurodegenerative disorder, affecting approximately 1,000,000 persons in the United States, with 60,000 new cases and 38,000 deaths annually. PD is a progressive neurodegenerative disease that initiates with dysfunction of a small protein known as alpha-synuclein, inside and outside of the brain. The common features of PD include tremors at a resting state, slowing or lack of control of movement and postural instability. These features of the disease arise from degeneration of neurons that secrete dopamine to transmit neurological signals. The degeneration of these dopaminergic neurons in nigrostriatal area of the brain near the brainstem, coupled with the accumulation of alpha-synuclein protein aggregates in cell bodies and terminals known as Lewy bodies, have long been thought to be the cause of the disease. Less well known are the features of this disease can affect serotonin levels, cholinergic, and norepinephrine neurons and nerve cells in the olfactory system, cerebral hemisphere, brain stem, spinal cord, and peripheral autonomic nervous system such as in the GI tract. Currently, these non-dopaminergic features are not properly controlled with dopamine-replacement or levodopa therapy.
About Inhibikase (www.inhibikase.com)
Inhibikase (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease and related disorders. Inhibikase’s multi-therapeutic pipeline focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson’s disease inside and outside the brain. Inhibikase is currently enrolling its Phase I, randomized single ascending dose and multiple ascending dose study to determine the safety, tolerability and pharmacokinetics of IkT-148009 in older and healthy subjects. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including statements regarding the closing of the initial public offering and the proceeds of the initial public offering, are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Inhibikase’s filings with the SEC, including its registration statement on Form S-1, as amended (File No. 333-240036), including under the caption “Risk Factors.” Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
Contacts
Company Contact:
Milton H. Werner, PhD
President & CEO
678-392-3419
info@inhibikase.com
Investor Relations:
Alex Lobo
SternIR, Inc.
alex.lobo@sternir.com