Clinical Trial Evaluating ITI-214 is Recruiting Parkinson’s Patients

Catarina Silva, MSc avatar

by Catarina Silva, MSc |

Share this article:

Share article via email
Parkinson's therapy trial

A Phase 1/2 clinical trial evaluating ITI-214 in patients with Parkinson’s disease (PD) has begun enrolling patients, Intra-Cellular Therapies announced.

ITI-214 is a potent and selective inhibitor of the phosphodiesterase 1 (PDE1) enzyme, which is involved in the degradation of both cAMP and cGMP (cyclic nucleotides). These are within-cell messengers for various signals in the nervous system. PDE1 activity is often high when disease is present, and PDE1 inhibitors are designed to re-establish normal function.

It has been shown that ITI-214 is generally well-tolerated and has a favorable safety profile. The results that led to these discoveries came from four Phase 1 clinical trials involving healthy subjects and schizophrenia patients.

Additionally, studies using animal models reported that neurodegeneration and neuroinflammation were reduced when PDE1 was inhibited, which suggests a possible use for ITI-214 in neurodegenerative diseases, like PD. PDE1 inhibitors also were shown to increase the effect of L-DOPA and other dopamine replacement therapies for motor symptom control, while blocking the adverse involuntary muscle movements induced by these treatments.

The newly-started ITI-214-195 Phase 1/2 trial is a double-blind, placebo-controlled, multiple ascending dose study (NCT03257046). The goal is to evaluate ITI-214’s safety and tolerability in idiopathic PD patients. To do so, researchers randomly will assign PD patients who are on stable PD therapy, to placebo or ITI-214 (1, 3 or 10 mg administered orally once a day for seven days).

The trials’ secondary objectives include the study of the drugs’ absorption, distribution, metabolism, and excretion; the investigation of ITI-214’s usefulness as control therapy for PD motor fluctuations and non-motor symptoms, such as daytime sleepiness. The team also will look for biological markers of disease progression, like those associated to inflammation.

“ITI-214 is a potent and selective phosphodiesterase 1 (PDE1) inhibitor. Following the favorable safety and tolerability results in our Phase 1 program, we are pleased to announce the advancement of ITI-214 for the treatment of patients with Parkinson’s disease,” Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, said in a press release. “This study is designed to evaluate the safety and tolerability of ITI-214 in this patient population, as well as evaluate the ability of ITI-214 to treat both motor and non-motor symptoms associated with Parkinson’s disease and to provide a framework for future trials to assess disease modification.”

Your Parkinson’s Community

Woman laying down illustration

Visit the Parkinson’s News Today forums to connect with others in the Parkinson’s community.

View Forums