ARM210 for Ventricular Tachycardia

No longer recruiting at 1 trial location

Overseen By Eugene E Marcantonio, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Armgo Pharma, Inc.

Must be taking: CPVT standard-of-care

Must not be taking: CYP2C8 inducers/inhibitors, Antacids

Disqualifiers: Alcoholism, Epileptic seizures, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, S48168 (ARM210), to determine its safety and effectiveness in treating Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT1), a condition causing dangerous heart rhythms during exercise or excitement. The drug repairs faulty heart channels that lead to these rhythm changes. Participants will receive either the drug or a placebo (a pill with no active drug) once daily for 28 days. Ideal candidates have a confirmed genetic diagnosis of CPVT1 and continue to experience irregular heartbeats despite current treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol requires that any daily medicines and dietary supplements be approved by the study's principal investigator and sponsor. Some medications may need a washout period (time without taking certain medications) before joining the study.

Is there any evidence suggesting that S48168 (ARM210) is likely to be safe for humans?

Research has shown that S48168 (ARM210) is safe and well-tolerated in people. In an earlier study, patients taking 120 mg and 200 mg daily experienced no major safety problems, meaning the treatment did not cause serious side effects. Another study examined its use for ventricular tachycardia, a heart rhythm disorder, and also found it to be well-tolerated.

These studies indicate that ARM210 has undergone safety testing at different doses, with positive results. For those considering joining a trial, this suggests that the treatment is generally safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ventricular tachycardia?

Most treatments for ventricular tachycardia focus on stabilizing the heart's rhythm through medications like beta-blockers, antiarrhythmics, or procedures such as catheter ablation. But S48168 (ARM210) works differently, targeting the underlying cellular mechanisms that cause the arrhythmia. This oral medication is designed to be taken once daily, potentially simplifying the treatment regimen for patients. Researchers are excited because ARM210 offers a novel approach that might improve heart rhythm stability more effectively and with fewer side effects than current options.

What evidence suggests that S48168 (ARM210) might be an effective treatment for CPVT?

Research has shown that S48168 (also known as ARM210) might help treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT1), a heart condition caused by calcium leaks that lead to dangerous heart rhythms. S48168 aims to repair these leaks, potentially restoring normal heart function. Early results suggest that this treatment might enable patients to live normal lives by preventing these risky heart rhythms. While there is hope for its effectiveness, further research is needed to confirm these benefits. Participants in this trial will receive either S48168 (ARM210) or a matching placebo to further evaluate its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael J Ackerman, MD PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults aged 18-65 with a confirmed genetic diagnosis of CPVT1 and related symptoms, who can follow the study plan and are not pregnant or breastfeeding. They must have a BMI ≤ 36 kg/m2, no recent drug abuse, controlled diabetes if present, no significant heart issues in the past five years, and agree to avoid certain medications and blood donations before and during the trial.

Inclusion Criteria

I have CPVT1 with symptoms, even on my current treatment.

I cannot become pregnant.

My daily medications and supplements are approved for the trial, or I can stop them before joining.

Exclusion Criteria

Participation in clinical trials for other therapeutic investigational drugs simultaneously or within the 4 weeks prior to the first dose of study drug

I can avoid taking non-approved medicines or supplements starting 2 weeks before and during the study.

I am not mentally or legally able to make decisions at the time of screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive S48168 (ARM210) or placebo once daily for 28 days to assess safety, tolerability, and preliminary efficacy

4 weeks

Continuous monitoring with wearable cardiac device

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Matching Placebo
• S48168 (ARM210)

Trial Overview The trial is testing S48168 (ARM210), which aims to fix leaky calcium channels caused by CPVT1 mutations that lead to dangerous heart rhythms. Participants will either receive this new drug or a placebo without knowing which one they're getting to compare effectiveness.

How Is the Trial Designed?

Group I: S48168 (ARM210) once daily for 28 days Experimental Treatment 1 Intervention

Oral dose of S48168 (ARM210) once daily on top of standard of care regimen for 28 days.

Group II: Matching Placebo once daily for 28 days Placebo Group 1 Intervention

Oral dose of placebo once daily on top of standard of care regimen for 28 days.

Who Is Running the Clinical Trial?

Armgo Pharma, Inc.

Lead Sponsor

Trials

2

Recruited

20+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05122975?cond=Ventricular%20tachycardia,%20catecholaminergic%20polymorphic,%201&viewType=Table&rank=1

Treatment of an Inherited Ventricular Arrhythmia S48168 (ARM210) repairs these leaky channels and can be a disease-modifying therapy restoring normal function to the channels. This result would allow patients ...

2. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/53588/pdf

A Phase II, Double-Blind 2-arm study to The purpose of this trial is to investigate the effect of S48168 (ARM210) on abnormal heart beats, safety, tolerability and blood levels ...

3. forbion.com forbion.com/news-insights/news/armgo-pharma-publishes-positive-phase-1b-trial-results-of-rycal-arm210-for-the-treatment-of-ryanodine-receptor-1-related-myopathies/

ARMGO Pharma Publishes Positive Phase 1b Trial Results ARM210 (S48168) is currently undergoing Phase 2 clinical development for a second orphan indication, Catecholaminergic Polymorphic Ventricular ...

4. withpower.com withpower.com/trial/phase-3-tachycardia-11-2021-33619

ARM210 for Ventricular Tachycardia · Info for Participants Trial Overview The trial is testing S48168 (ARM210), which aims to fix leaky calcium channels caused by CPVT1 mutations that lead to dangerous heart rhythms.

5. trial.medpath.com trial.medpath.com/clinical-trial/27dc3cd55fbb1e76/effect-s48168-cpvt1-adults

A Phase II, Double-Blind 2-arm study to investigate the effect ... A Phase II, Double-Blind 2-arm study to investigate the effect on ventricular ectopy, safety, tolerability and pharmacokinetics of S48168 (ARM210) compared ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20542946

Treatment of an Inherited Ventricular Arrhythmia The purpose of this study is to measure the effect on ventricular ectopy, safety, tolerability and pharmacokinetics of S48168 (ARM210) compared with placebo ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05122975?cond=VENTRICULAR%20TACHYCARDIA,%20CATECHOLAMINERGIC%20POLYMORPHIC&rank=4

Treatment of an Inherited Ventricular Arrhythmia The goal of the proposed project is to determine the safety and tolerability as well as the preliminary efficacy of a novel small molecule drug, S48168 ...