KYN-5356 for Schizophrenia

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Kynexis B.V.

Must be taking: Antipsychotics

Disqualifiers: Substance use disorder, unstable condition, others

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

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: 33

Duration: 28 days

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, KYN-5356, to evaluate its efficacy and safety in treating schizophrenia. Participants will receive a low, medium, or high dose of the medication, or a placebo, for 28 days. The goal is to understand how different doses affect symptoms and brain function in individuals with schizophrenia. Eligible participants must have been diagnosed with schizophrenia for at least a year, be stable in their condition, and have been taking only one antipsychotic medication for at least two months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in schizophrenia treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stay on your current antipsychotic medication if it's a single, stable treatment you've been on for at least 2 months. You cannot be on more than one antipsychotic medication.

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

Research has shown that KYN-5356 has been safe in earlier human studies. In a previous trial, healthy participants handled the treatment well, with no major safety issues reported. The treatment is a small molecule targeting an enzyme called KAT-II, which plays a role in brain function.

Participants in the initial studies did not experience significant negative side effects, suggesting that KYN-5356 is generally well-tolerated. However, as with any treatment, individual reactions may vary. Participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for schizophrenia, like antipsychotics, work by blocking dopamine receptors. However, KYN-5356 is unique because it targets a different pathway in the brain, potentially offering relief with fewer side effects. Researchers are excited about KYN-5356 because it could provide a new option for patients who don't respond well to existing medications. By offering different doses—low, medium, and high—this treatment could be tailored to individual patient needs, which is a big step forward in personalized medicine for schizophrenia.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research shows that KYN-5356 is designed to improve thinking and memory in people with schizophrenia. In earlier studies, patients demonstrated that KYN-5356 was safe and worked well in the body, as it was absorbed and processed effectively. As the first of its kind tested in humans, KYN-5356 targets specific brain functions linked to thinking problems in schizophrenia. Although human studies have provided limited information, early results suggest that KYN-5356 might help manage cognitive symptoms related to the condition. Participants in this trial will receive either a high, medium, or low dose of KYN-5356, or a placebo, to further evaluate its effectiveness and safety. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults with cognitive impairment due to schizophrenia may join this trial. Participants will stay in a clinic for 32 days and take the study drug or placebo for 28 days. They must be able to undergo various assessments, including safety checks and possibly brain function tests.

Inclusion Criteria

Has a body mass index (BMI) between 18 and 40 kg/m2 Inclusive

Signed and dated written informed consent before screening in accordance with Good Clinical Practice

I have been diagnosed with schizophrenia.

Exclusion Criteria

A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening

Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol)

I am currently taking more than one antipsychotic medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KYN-5356 or placebo for 28 days with efficacy, safety, PK, and PD assessments

28 days

In-residence at clinic for 32 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person) on Day 42

What Are the Treatments Tested in This Trial?

Interventions

• KYN-5356 High Dose
• KYN-5356 low dose
• KYN-5356 Medium Dose
• Placebo

Trial Overview

The trial is testing KYN-5356 at three different doses against a placebo to see if it's effective and safe for treating cognitive issues in schizophrenia. It includes close monitoring over a month, with follow-up after discharge.

How Is the Trial Designed?

Group I: KYN-5356 medium dose Experimental Treatment 1 Intervention

KYN-5356 medium dose, oral tablet for 28 days

Group II: KYN-5356 low dose Experimental Treatment 1 Intervention

KYN-5356 low dose, oral tablet for 28 days

Group III: KYN-5356 high dose Experimental Treatment 1 Intervention

KYN-5356 high dose, oral tablet for 28 days

Group IV: Placebo Placebo Group 1 Intervention

Placebo, oral tablet for 28 days

Who Is Running the Clinical Trial?

Kynexis B.V.

Lead Sponsor

Trials

1

Recruited

70+

Citations

1.

kynexistx.com

kynexistx.com/news/phase-2-first-patient-dosed

Kynexis Announces First Patient Dosed in Phase 2 Clinical ...

... KYN-5356 to improve cognitive function in people with schizophrenia. By combining standardized cognitive performance measures with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07191483

NCT07191483 | A Study to Evaluate KYN-5356 in Adults ...

These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, ...

3.

forbion.com

forbion.com/media/fbcjcpqh/1837-kynexis-announces-positive-topline-results-from-phase-1-study-of.pdf

Kynexis Announces Positive Topline Results from Phase 1 ...

“As the first KAT-II inhibitor studied in humans, KYN-5356 has demonstrated an excellent safety profile and promising pharmacokinetic data, ...

4.

synapse.patsnap.com

synapse.patsnap.com/article/kynexis-reports-promising-phase-1-results-for-kyn-5356-in-treating-schizophrenia-related-cognitive-impairment

Kynexis Reports Promising Phase 1 Results for KYN-5356 ...

The recent study aimed to assess the safety, tolerability, and pharmacokinetics of KYN-5356 in healthy volunteers, administering both single and ...

5.

globenewswire.com

globenewswire.com/news-release/2025/09/30/3158423/0/en/Kynexis-Announces-First-Patient-Dosed-in-Phase-2-Clinical-Trial-of-KYN-5356-for-Cognitive-Impairment-Associated-With-Schizophrenia.html

Kynexis Announces First Patient Dosed in Phase 2 Clinical

The Phase 2 trial builds on positive results from Kynexis's first-in-human Phase 1 trial, in which KYN-5356 demonstrated an excellent safety and ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-kyn-5356-in-healthy-subject

A Study to Investigate the Safety, Tolerability, and ...

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KYN-5356 in Healthy Subjects Aged 18 to 55 Years. K. Kynexis. Status ...

7.

kynexistx.com

kynexistx.com/news/kynexis-announces-initiation-of-first-in-human-phase-1-study-of-kyn-5356

Kynexis Announces Initiation of First-in-Human Phase 1 ...

KYN-5356, a clinical-stage small molecule targeting a key enzyme in the kynurenine pathway known as KAT-II, is being developed for cognitive impairment ...