Inhibikase Therapeutics reported new biomarker details and enrollment updates for its Phase II Parkinson’s disease program.
Inhibikase will implement a biomarker analysis of alpha-synuclein status in its ongoing Phase IIa trial in untreated Parkinson’s disease (NCT05424276). Recently published research from the Michael J Fox Foundation for Parkinson’s Disease Research validated alpha-synuclein as a biomarker for acutely diagnosing and monitoring the neurodegenerative disease.
Inhibikase’s 120-patient Phase IIa study evaluates Inhibikase’s small molecule IkT-148009. The primary outcome is safety, while secondary endpoints include measures of Parkinson’s disease symptoms, movement disorders, sleep, and quality of life.
Inhibikase reported that it expects 11 out of 35 trial sites to be screening patients by the end of April, and 30 sites to be screening by the end of Q2. The company will report further details on its plans to incorporate biomarker analyses using skin biopsies at the American Academy of Neurology meeting on April 26.
IkT-148009 inhibits Abelson tyrosine kinase, an enzyme implicated in the dopaminergic pathway, thereby generating a neuroprotective effect.
Parkinson’s disease dosing updates
Inhibikase has also asked the US Food and Drug Administration (FDA) for permission to include a higher dose of IkT-148009 based on new data evaluating a 200mg dose. The 200mg dose was reported to be safe and well-tolerated in newly reported data.
Meanwhile, Inhibikase presented additional Phase Ib data (NCT04350177) evaluating 50mg and 100mg doses of IkT-148009. The updated analysis included early efficacy signals along Parkinson’s disease rating scales from the 101-subject study, which included both healthy volunteers and patients with Parkinson’s disease.
As Inhibikase continues to make progress in the Parkinson’s disease space, the biotech joins an increasingly crowded drug development field. Meanwhile, new progress in novel biomarkers and digital therapeutics have opened the door to new treatment possibilities. GlobalData predicts global sales of $11.5 billion in 2029 for marketed Parkinson’s disease treatments.