IKT is Currently Performing Phase I Clinical Trials
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NASDAQ Listed Clinical-Stage Pharmaceutical Company.
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Focus on Development of Effective Therapeutics for Parkinson’s and Related Neurodegeneration Disorders as well as Certain Cancers.
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$20.4 Million in Grant Funding Plus $19 Million in Investor Capitol.
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Phase I Trials for Proprietary Therapy Drug on Accelerated Plan.
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Experienced Management, Consultants, Board of Directors and Nearly All KOLs in the Field on Scientific Advisory Board.
Inhibikase Therapeutics, Inc. (NASDAQ: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease and related disorders. The IKT multi-therapeutic pipeline focuses on neurodegeneration and its lead program for IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, intends to treat Parkinson’s disease inside and outside the brain.
IKT is currently performing 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. IKT is also advancing a novel drug delivery platform to treat certain forms of cancer at the same time as it is developing novel drugs for the treatment of neurodegenerative disease. IKT is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.
IKT is Driving Functional Reversal of Parkinson’s Disease
• Multi-therapeutic pipeline with emphasis on neurodegeneration inside and outside of the brain.
• Our lead inhibitor of the Abelson Tyrosine Kinase (c-Abl), IkT-148009, halts and reverses functional loss in animal models that recreate progressive human disease.
• Five clinical programs in neurodegeneration and one clinical program in oncology by close of 2021.
• Ongoing Phase 1 trial with IkT-148009 reaches therapeutic drug exposures seen in animal models at just 25 mg oral dose 1x/day in humans.
• Multiple patent families for lead compound with expiration of 2036 and beyond
• $20.4 million in grants and contracts from NIH, DoD, the Michael J. Fox Foundation and the Georgia Research Alliance, all peer-reviewed
• $19 million in investor capital since 2018.
• Highly experienced and respected management team, consultants, Board of Directors and nearly all KOLs in the field on Scientific Advisory Board.
First Quarter 2021 Highlights of Recent Activity
On May 17thIKT reported financial results for the first quarter ended March 31, 2021 and highlighted recent developments.
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Accelerated timelines for Phase 1 Study of IkT-148009 for the treatment of PD and associated GI Disorders: In February 2021 IKT commenced patient dosing in its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of IkT-148009, the Company’s novel brain penetrant Abelson tyrosine kinase (c-Abl) inhibitor with the potential to modify Parkinson’s disease and its gastrointestinal complications. In April 2021, IKT announced that it had accelerated the timeline for completion of the study based on early data that provided the opportunity to seek regulatory approval to commence dosing of PD patients in the third quarter of 2021, much earlier than previously anticipated.
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Advancing chronic toxicology studies of IkT-148009 to permit long-term dosing in patients: In January 2021 IKT initiated 3- and 6-month long-term toxicology studies of IkT-148009 in mice and 3- and 9-month long-term toxicology studies of IkT-148009 in primates as required to obtain regulatory approval for chronic administration of IkT-148009 in patients. IKT has completed 3-month toxicology studies and is presently completing its histopathology analysis in preparation for submission of the data for regulatory review early in the third quarter of 2021. IKT expects to complete 6- and 9-month toxicology studies in the fourth quarter of 2021.
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Initiated clinical batch manufacturing and pill formulation of IkT-001Pro. In February, 2021, IKT initiated clinical batch manufacturing and final product formulation of IkT-001Pro, the IKT prodrug formulation of Imatinib, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). IKT expects to file an Investigational New Drug (IND) application in the third quarter of 2021, with initiation of clinical development as soon as practicable after the filing, subject to FDA acceptance of the IND.
The acceleration of the Phase 1 study for its lead candidate, IkT-148009 should allow IKT to move into evaluation of the safety, tolerability and pharmacokinetics in Parkinson’s patients early in the third quarter of 2021. Concurrently, IKT is advancing two long term toxicology studies in animals, which will allow for chronic administration of IKT-148009 in patients following FDA review and acceptance.
In the third quarter of 2021, IKT plans to file its IND application for IKT-001Pro, which holds the potential to be a safer and better tolerated treatment for cancers such as CML and expects to initiate clinical development as soon as practicable following the submission of the IND application.
For more information on Inhibikase (ITK) visit: www.inhibikase.com
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Media Contact
Company Name: Inhibikase Therapeutics, Inc.
Contact Person: Media Relations
Email: Send Email
Phone: 678 392 3419
Address:3350 Riverwood Parkway Suite 1900
City: Atlanta
State: GA 30339
Country: United States
Website: https://www.inhibikase.com/