IkT-148009 for Parkinson's Disease

No longer recruiting at 36 trial locations

Overseen By Carl Klint

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ABLi Therapeutics, Inc.

Must not be taking: Antipsychotics, Amphetamines, Levodopa, others

Disqualifiers: Atypical parkinsonism, Hallucinations, Substance abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new drug, IkT-148009, to determine if it can improve symptoms in people with Parkinson's disease who haven't started treatment. Researchers aim to assess the drug's safety and its effects on both movement and non-movement symptoms of Parkinson's. Participants will take one of three doses or a placebo (a dummy treatment) daily for 12 weeks. Ideal candidates have bradykinesia (slowness of movement) and motor asymmetry, haven't taken any Parkinson's medication, and won't need new treatments during the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop certain medications to join the trial. You cannot be on any anti-parkinsonian therapy, and you must not have taken certain medications like levodopa or monoamine oxidase-B inhibitors within 28 days before screening. If you've used irreversible monoamine oxidase-B inhibitors, they must be stopped at least 90 days before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IkT-148009 has undergone safety testing in several studies. In studies with healthy older adults, IkT-148009 was generally well-tolerated, with most participants not experiencing major side effects. This suggests the drug is safe at certain doses. Additionally, the FDA allowed further testing of IkT-148009 after reviewing data and determining it safe enough to continue.

The current trial phase focuses on safety and tolerability in people with untreated Parkinson's disease. Researchers are still gathering information to confirm the drug's safety and tolerability for this group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's?

Researchers are excited about IkT-148009 for Parkinson's Disease because it brings a fresh approach to treatment. Unlike standard options like levodopa or dopamine agonists, which primarily boost dopamine levels, IkT-148009 targets underlying disease mechanisms. This drug is designed to inhibit the LRRK2 enzyme, which is thought to play a crucial role in the progression of Parkinson's by affecting cellular processes. By focusing on this enzyme, IkT-148009 could potentially slow disease progression, offering hope for a more effective, long-term solution.

What evidence suggests that IkT-148009 might be an effective treatment for Parkinson's disease?

Research has shown that IkT-148009 could be promising for treating Parkinson's disease. Studies have found that IkT-148009 helps protect brain cells from damage. In lab tests, it restored the function of certain brain cells in mice with Parkinson's. The drug blocks a protein called c-Abl, which can reach the brain. Early studies in humans showed that IkT-148009 is safe and well-tolerated. These promising results suggest that IkT-148009 may help with Parkinson's symptoms. ^{5 6 7 8 9}

Who Is on the Research Team?

Milton Werner, PhD

Principal Investigator

ABLi Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for people aged 30-80 with untreated Parkinson's Disease (PD) who meet specific medical criteria and can self-administer a drug daily with food. They must not need other PD treatments during the study, agree to birth control methods if of childbearing potential, and have no significant health issues that could affect participation.

Inclusion Criteria

I have Parkinson's disease with slow movements and uneven symptoms on both sides.

I am not on any medication for Parkinson's disease.

Montreal Cognitive Assessment ≥ 24

Exclusion Criteria

I have advanced or intermediate age-related vision loss.

I experience significant dizziness when standing up.

I haven't taken Parkinson's disease medications or supplements for over 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive one of three doses of IkT-148009 or placebo once daily for 12 weeks

12 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• IkT-148009
• Placebo

Trial Overview The trial tests IkT-148009's safety and how it affects the body compared to a placebo in managing Parkinson's symptoms. Participants will randomly receive either one of three doses of IkT-148009 or a placebo once daily for 12 weeks.

How Is the Trial Designed?

Group I: 50mg IkT-148009 (risvodetinib) Experimental Treatment 1 Intervention

This arm consisted of participants treated with the 50mg dose of risvodetinib.

Group II: 200mg IkT-148009 (risvodetinib) Experimental Treatment 1 Intervention

This arm consisted of participants treated with the 200mg dose of risvodetinib.

Group III: 100mg IkT-148009 (risvodetinib) Experimental Treatment 1 Intervention

This arm consisted of participants treated with the 100mg dose of risvodetinib.

Group IV: Placebo Placebo Group 1 Intervention

This arm consisted of participants treated with placebo.

Who Is Running the Clinical Trial?

ABLi Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

450+

Inhibikase Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

450+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05424276

NCT05424276 | A Randomized, Double-Blind, Placebo- ... This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old).

2. cureparkinsons.org.uk cureparkinsons.org.uk/2023/01/inhibikase-new-drug/

Biotech Inhibikase develops new drug for Parkinson's Researchers have published laboratory data demonstrating the neuroprotective effects of a new potential drug for Parkinson's called IkT-148009.

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000205150

The 201 Trial in Untreated Parkinson's Disease (P9-3.011) Objective:To evalute the safety, tolerability and clinical benefit of risvodetinib (IkT-148009) in untreated Parkinson's disease.

4. inhibikase.com inhibikase.com/news/press-releases/detail/63/inhibikase-therapeutics-to-present-data-from-phase-11b

Inhibikase Therapeutics to Present Data from Phase 1/1b ... "These data highlight that IkT-148009 is safe and well tolerated over 7-days of daily dosing, with high systemic exposure and persistent ...

5. science.org science.org/doi/10.1126/scitranslmed.abp9352

The c-Abl inhibitor IkT-148009 suppresses ... - Science IkT-148009, a c-Abl inhibitor that can cross the blood-brain barrier, rescued dopaminergic neuron deficits in mouse models of inherited and sporadic PD.

6. inhibikase.com inhibikase.com/investors/news-events/press-releases/detail/72/inhibikase-therapeutics-announces-fda-has-lifted-the-full

Press Releases Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Parkinson's Disease ... safety data. With ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05424276

NCT05424276 | A Randomized, Double-Blind, Placebo- ... This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old).

8. inhibikase.com inhibikase.com/news/press-releases/detail/84/inhibikase-therapeutics-provides-safety-and-functional

Press Releases IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain as well as other diseases.

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04350177?term=IkT-148009&draw=2&rank=1

A Study to Assess Single and Multiple Doses of IkT-148009 ... This study investigates the safety and tolerability of drug IkT-148009 in healthy elderly volunteers (55 to 70 years old). This first-in-human study is ...