IkT-148009 was well-tolerated with high systemic exposure and persistent penetration into the central nervous system (CNS) in older and elderly healthy volunteers and Parkinson's patients

No clinically significant adverse events observed

Actively enrolling Phase 2a '201' clinical trial of IkT-148009 in patients with untreated Parkinson's disease

BOSTON and ATLANTA, Sept. 15, 2022 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that it will present safety, tolerability, pharmacokinetics and exploratory Parkinson's assessment data from the Company's Phase 1/1b '101' study of IkT-148009 in Parkinson's disease at the International Congress of Parkinson's Disease and Movement Disorders tomorrow, September 16^th, 2022. The congress is being held in Madrid, Spain and virtually between September 15-18, 2022.

"We are pleased to present data from the phase 1/1b study of our oral Abelson tyrosine kinase (c-Abl) inhibitor, IkT-148009," said Milton Werner, Ph.D, President and CEO of Inhibikase Therapeutics. "These data highlight that IkT-148009 is safe and well tolerated over 7-days of daily dosing, with high systemic exposure and persistent penetration into the CNS in both healthy volunteers and patients with Parkinson's disease. Importantly, assessments of motor, non-motor and quality of life in patients enrolled in the study showed that treatment with IkT-148009 did not worsen disease over 7-day dosing. Combined with our previously reported preclinical data, which demonstrated the ability of IkT-148009 to protect neurons from degeneration and induce functional recovery, we remain encouraged by the treatment potential of IkT-148009 and are actively enrolling patients in our Phase 2a '201' study, with 14 clinical sites opened."

Presentation Details:

Abstract Title: IkT-148009 as a potential disease-modifying therapy in PD
Abstract Number: 789
Session: GPT 6, Parkinson's Disease: Clinical Trials
Presentation Date & Time: September 16, 2022, 1:00 – 3:00 p.m. CEST / 7:00 – 9:00a.m. EST
Location: France Gallery, Madrid Marriott Auditorium Hotel and Conference Center

The Phase 1/1b study was a single and multiple ascending dose safety, tolerability and pharmacokinetics trial evaluating once daily administration of IkT-148009 over 7 days. The study evaluated single doses between 12.5 mg and 325 mg per day and multiple doses up to 100 mg in 88 older and elderly healthy adults and subsequently in 14 patients with mild to moderately advanced Parkinson's disease. These data highlight that IkT-148009 was well-tolerated, exhibiting linear dose proportionality, high systemic exposure, and persistent penetration into the CNS. In addition, the safety and tolerability profile of IkT-148009 in healthy subjects was consistent with chronic toxicology studies in mice and non-human primates. Parkinson's patients with mild to moderate disease (Hoehn & Yahr < 3.0) displayed a similar safety and tolerability profile to healthy volunteers. There were no clinically significant adverse events observed.

About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline has a primary focus 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 as well as other diseases that arise from Ableson Tyrosine Kinases. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be potentially applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.

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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 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 annual report on Form 10-K for the year ended December 31, 2021, 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, Ph.D.
President & CEO
678-392-3419
info@inhibikase.com

Investor Relations:
Alex Lobo
SternIR, Inc.
alex.lobo@sternir.com

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SOURCE Inhibikase Therapeutics, Inc.