Exhibit 99.1
Inhibikase Therapeutics Issues a Letter to Shareholders and Comments on Recent Trading Activity
BOSTON and ATLANTA, September 20, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage
pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinsons disease (PD), Parkinsons-related disorders and other diseases of the Abelson
Tyrosine Kinases, today issued a Letter to Shareholders in response to recent price volatility.
Dear Fellow Shareholders of Inhibikase Therapeutics:
We have watched, as have you, as the value of IKT has dropped dramatically in the last 8 trading sessions. Days of unusually high volume and steep declines in
price have impacted the stock with no identifiable cause. We are continuing to advance our work in Parkinsons Disease, Chronic Myelogenous Leukemia (CML) and Multiple System Atrophy (MSA), and there is no new information concerning this
work that we believe could account for the volatility in share price in recent days.
Let me first address risvodetinib
(IkT-148009) in Parkinsons and related diseases. At the recent Movement Disorder Society (MDS) Congress in Copenhagen, Denmark (August 26-September 1, 2023), we
presented safety and tolerability data across 119 people that reinforces our belief that risvodetinib is safe and well tolerated, and that there are no side effects of clinical significance at any dose or treatment duration measured to date. These
data are presented in our corporate presentation on the Inhibikase website. At the Congress, we further detailed the changes in Parkinsons functional assessments relative to baseline in 2-3 patients at
each of the 50, 100 and 200 mg doses. These data comes from the 8 active and 3 placebo patients that had been enrolled prior to the FDA Clinical Hold placed on the 201 Trial in November, 2022. These data support the importance of the ongoing 201
Trial in untreated Parkinsons disease that restarted with its first enrolled patient in May, 2023 following the lifting of the Clinical Hold in January of this year. Presently, 28 of the 120 planned patients are in the consenting or screening
process or already enrolled in the trial. As we recently announced, one participant has already completed the 12-week dosing period and is awaiting the opportunity to participate in the planned 12 month
extension study.
The implementation of our patient outreach program and launch of our patient portal (www.the201trial.com) is also providing
avenues for accelerating trial enrollment. The pre-qualification questionnaire acts as a filter through which potential participants can pass and directly contact a nearby site. During September, the pre-qualification process identified an additional 50 potential participants. We believe this approach will assist all sites in concentrating their consenting and screening efforts on individuals who already meet
the basic criteria for enrollment. We are encouraged by these statistics as the public awareness of the 201 Trial grows amongst the untreated Parkinsons patient community and their caregivers and support networks.
We also presented evidence for the wider applicability of risvodetinib to other Parkinsons-related disease at
the MDS Congress, showing functional benefit in models of Multiple System Atrophy (MSA), an orphan disease that is a rapidly progressing form of Parkinsonism.
Finally, we continue to make significant progress on the path to approval of IkT-001Pro in Stable Phase Chronic Myelogenous Leukemia. IkT-001Pro is our
prodrug of the anticancer agent imatinib mesylate. We have completed the necessary steps to request an FDA meeting to seek agreement on the path to approval under the 505(b)(2) regulation. Simultaneously, we continue to differentiate IkT-001Pro from
standard-of-care by measuring bioequivalence to 600 mg imatinib mesylate, a dose for standard-of-care imatinib mesylate which is commonly in use, but poorly tolerated by patients. This high dose cohort is expected to be completed early in the 4th
quarter of 2023.
|
|
|
|
|
|
|
3350 Riverwood Parkway SE, Ste 1900 |
|
|
|
|
|
1 Cranberry Hill, Suite 200 |
Atlanta, GA 30339 |
|
|
|
|
|
Lexington, MA 02421 |
678-392-3419 |
|
|
info@inhibikase.com |
|
|
617-936-0184 |