Inhibikase Therapeutics Inc. (NASDAQ: IKT) stock gains by 1.03% in the current market trading session. Inhibikase Therapeutics is a clinical-stage pharmaceutical business focused on finding treatments for Parkinson’s disease and other neurodegenerative diseases.
What is PD?
Parkinson’s disease (PD) is the 2nd most frequent neurodegenerative condition in the United States, affecting roughly 1,000,000 people and resulting in 60,000 new cases and 38,000 deaths each year. PD is a progressive neurodegenerative illness that begins with the misfolding of alpha-synuclein, a tiny non-essential protein found both within and outside the brain.
IKT stock’ Significant Development
Inhibikase Therapeutics released intermediate three-month results from its continuing chronic toxicity studies in rats and non-human primates using oral IkT-148009 (NHPs).
The Company’s continuing toxicity studies of IkT-148009 are created to accommodate regulatory criteria for chronic treatment in humans, which include daily oral administration for six months in rats and nine months in NHPs. Inhibikase has introduced three-month dosing cohorts in rats and NHPs to enable assessment in Parkinson’s patients for up to three months in its planned Phase 2a research, in addition to these criteria. The three-month intermediate findings from both animal species are included in the report, showing that the toxicological profile for IkT-148009 improved as the medication was dosed longer.
Prior to starting the Company’s Phase 1 study of IkT-148009 in older healthy people, Inhibikase submitted 14-day toxicity data in rats and NHPs to the US Food and Drug Administration. The No Adverse Event Level, a measure of medication safety in animals, was determined to be 31.2 mg in NHPs over the 14-day trial, but not in rats. NOAEL measurements in rats and NHPs after three months of treatment were 50 mg and 75 mg, respectively, showing a 2.4-fold increase in NHPs and maintaining a standard for rats.
Following FDA evaluation of these three-month toxicological data, the Company expects to start a Phase 2a trial in 2022 to test daily oral administration of IkT-148009 in up to 120 Parkinson’s patients for three months, if the Agency agrees.