What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include Tyrosine Kinase Inhibitors (TKIs) like Seralutinib, which target pathways such as PDGF, CSF1R, and c-KIT. Known side effects of TKIs can include hepatotoxicity, necessitating close monitoring of liver function, as well as gastrointestinal issues like nausea, vomiting, and diarrhea. Other side effects may include fatigue, hypertension, and skin rashes. Additionally, treatments like PDE5 inhibitors (e.g., sildenafil) and endothelin receptor antagonists (e.g., bosentan) are associated with fluid retention, peripheral edema, and potential liver function abnormalities.

What prior FDA approvals exist?

The FDA has approved several treatments for Pulmonary Arterial Hypertension (PAH), including Tyrosine Kinase Inhibitors (TKIs) and other drug classes. Nintedanib, a TKI targeting multiple pathways including PDGF, has been approved for conditions related to PAH. Additionally, other drug classes such as Endothelin Receptor Antagonists (ERAs) like bosentan and macitentan, Phosphodiesterase-5 Inhibitors (PDE5Is) like sildenafil and tadalafil, and soluble guanylate cyclase stimulants like riociguat have also been approved for PAH treatment. These drugs aim to improve exercise capacity, delay clinical worsening, and enhance overall quality of life in PAH patients.

What other types of research exist?

Promising alternatives to Seralutinib for PAH patients include Dasatinib, which has been studied for its effects on PAH, and Epoprostenol, a prostacyclin with a strong track record in improving exercise capacity and survival in PAH patients. Additionally, PDE-5 inhibitors like Sildenafil have shown favorable impacts on exercise capacity and hemodynamic variables in smaller studies.

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Kinase Inhibitor

Seralutinib for Pulmonary Arterial Hypertension

Q: What is the mechanism of action of this treatment?

Pulmonary Arterial Hypertension (PAH) treatments target various pathways to reduce pulmonary vascular resistance and improve heart function. Tyrosine Kinase Inhibitors (TKIs) like Seralutinib inhibit pathways such as PDGF, CSF1R, and c-KIT, which are involved in vascular remodeling and inflammation, thus potentially reversing disease progression. Phosphodiesterase-5 Inhibitors (PDE5Is) like sildenafil increase cyclic GMP levels, leading to vasodilation and improved blood flow. Endothelin Receptor Antagonists (ERAs) such as bosentan block endothelin-1, a potent vasoconstrictor, reducing vascular resistance. Soluble guanylate cyclase stimulants like riociguat enhance nitric oxide signaling, promoting vasodilation. These treatments are crucial for PAH patients as they help alleviate symptoms, improve exercise capacity, and potentially slow disease progression.

Phase 3

Recruiting

Research Sponsored by GB002, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult subjects aged 18 to 75 years

Diagnosis of PAH classified by one of the following: Idiopathic PAH (IPAH) or heritable PAH (HPAH), PAH associated with connective tissue disease (CTD-APAH) or anorexigen or methamphetamine use, Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair

Must not have

Requirement of IV inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) or IV diuretics for more than 24 hours within 4 weeks prior to Screening

Body weight < 40 kg at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 52 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called seralutinib to see if it can help people with a specific type of lung disease (PAH) improve their ability to exercise. The medication works by blocking signals that cause the blood vessels in the lungs to tighten and narrow. Seralutinib is delivered via inhalation and is being developed for patients with pulmonary arterial hypertension. The goal is to see if this can reduce lung pressure and delay worsening of the disease.

Who is the study for?

Adults aged 18-75 with Pulmonary Arterial Hypertension (PAH) who can walk between 150 and 450 meters in a six-minute test. They must have been on stable PAH medication for at least three months, have specific heart catheterization results, and not be pregnant or nursing. Participants need to use effective contraception if of childbearing potential.

What is being tested?

The trial is testing Seralutinib's effectiveness in improving exercise capacity for those with WHO Group 1 PAH who are classified as Functional Class II or III. It involves comparing Seralutinib against a placebo using a generic dry powder inhaler to see which is better at preventing clinical worsening.

What are the potential side effects?

While the side effects of Seralutinib are not detailed here, common side effects from similar treatments include breathlessness, headache, dizziness, nausea, diarrhea, rash and fatigue. The severity varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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My PAH is due to genetics, connective tissue disease, drug use, or heart defect repair.

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I am a man who will use a condom if I have sex with a woman who can get pregnant, from now until 90 days after my last treatment.

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I have been on a stable PAH medication for at least 12 weeks.

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I can walk between 150 and 450 meters without stopping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have needed strong heart or fluid medication through an IV for more than a day in the last month.

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My body weight is less than 40 kg.

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My PAH is related to HIV, schistosomiasis, portal hypertension, or POVD.

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I don't have any conditions that would affect my ability to perform a walking test.

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My kidney function is low and my blood count is below normal.

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I have a serious heart valve problem.

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I have previously participated in studies or been treated with seralutinib.

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I currently use inhaled tobacco, nicotine products, or marijuana.

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I haven't taken any tyrosine kinase inhibitors in the last 12 weeks.

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I have severe sleep apnea that hasn't been treated.

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My condition is classified under WHO Pulmonary Hypertension Groups 2 to 5.

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I have irregular heartbeats that doctors haven't been able to control.

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I have had blood clots in my lungs.

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My liver function is not normal, with specific test results above the usual range.

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I have had a procedure to create a hole in the wall between the upper chambers of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Proportion of subjects who achieve all of the following components of clinical improvement at Week 24, in the absence of clinical worsening

Proportion of subjects with each of the Clinical Worsening Outcomes

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Seralutinib 90 mgExperimental Treatment2 Interventions

Seralutinib inhaled orally BID up to 48 weeks

Group II: PlaceboPlacebo Group2 Interventions

Placebo inhaled orally twice daily (BID) up to 48 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Generic Dry Powder Inhaler

2020

Completed Phase 2

~160

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pulmonary Arterial Hypertension (PAH) treatments target various pathways to reduce pulmonary vascular resistance and improve heart function. Tyrosine Kinase Inhibitors (TKIs) like Seralutinib inhibit pathways such as PDGF, CSF1R, and c-KIT, which are involved in vascular remodeling and inflammation, thus potentially reversing disease progression. Phosphodiesterase-5 Inhibitors (PDE5Is) like sildenafil increase cyclic GMP levels, leading to vasodilation and improved blood flow. Endothelin Receptor Antagonists (ERAs) such as bosentan block endothelin-1, a potent vasoconstrictor, reducing vascular resistance. Soluble guanylate cyclase stimulants like riociguat enhance nitric oxide signaling, promoting vasodilation. These treatments are crucial for PAH patients as they help alleviate symptoms, improve exercise capacity, and potentially slow disease progression.