What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (e.g., bosentan, macitentan), PDE-5 inhibitors (e.g., sildenafil, tadalafil), and prostacyclins (e.g., epoprostenol, treprostinil). Endothelin receptor antagonists can cause fluid retention, liver enzyme abnormalities, and anemia. PDE-5 inhibitors may lead to headaches, flushing, dyspepsia, and visual disturbances. Prostacyclins often result in side effects such as jaw pain, nausea, diarrhea, and flushing. Treatments targeting PDGFR, CSF1R, and c-KIT, like Seralutinib, aim to reduce pulmonary vascular remodeling and inflammation, but specific side effects for Seralutinib are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH). These include endothelin receptor antagonists like bosentan and macitentan, phosphodiesterase type 5 inhibitors such as sildenafil and tadalafil, and prostacyclin analogues like epoprostenol, treprostinil, and iloprost. These drugs target various pathways to reduce pulmonary vascular resistance and improve symptoms. While Seralutinib, which inhibits PDGFR, CSF1R, and c-KIT, is still under investigation, it aims to reduce pulmonary vascular remodeling and inflammation, potentially offering a novel approach to PAH treatment.

What other types of research exist?

Promising novel alternatives to Seralutinib for PAH patients include: <ol> <li>Toceranib - Shown to significantly reverse right ventricular remodeling in PAH models.</li> <li></li> </ol> Pacritinib - A JAK2 and FLT3 inhibitor, effective in reducing symptom burden and spleen volume in myelofibrosis, which may have potential applications in PAH. 3. Nintedanib - A tyrosine kinase inhibitor with efficacy in idiopathic pulmonary fibrosis, potentially beneficial for PAH due to its anti-fibrotic properties.

← Back to Search

Tyrosine Kinase Inhibitor

GB002 for Pulmonary Arterial Hypertension

Phase 2

Recruiting

Research Sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Eligibility Criteria Checklist

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

Must have

Treatment with standard of care PAH disease-specific background therapies (stable dose).

Be older than 18 years old

Must not have

Chronic renal insufficiency

History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 80 months or availability of commercial product

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the long-term effects of GB002 (seralutinib) in patients who were part of an earlier study for Pulmonary Arterial Hypertension (PAH). Seralutinib is a new treatment developed for PAH and has shown better results compared to another treatment in early studies.

Who is the study for?

This trial is for adults who've completed a previous GB002 study for Pulmonary Arterial Hypertension (PAH) and were compliant. They must be on stable PAH medications, not have life-threatening heart issues, severe hypertension or hypotension, new left-sided heart disease, substance abuse problems, certain blood disorders or infections. They can't use inhaled tobacco/marijuana but may use ingestible/topical marijuana.

What is being tested?

The trial tests the long-term effects of an inhaler drug called GB002 (seralutinib) in patients with PAH who participated in earlier GB002 studies. It's an open-label extension which means everyone knows they're getting the actual drug and there's no placebo.

What are the potential side effects?

While specific side effects of GB002 are not listed here, common ones for PAH treatments include breathlessness, headache, dizziness, nausea and potential risks to liver function. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am on a stable dose of standard treatment for PAH.

Exclusion Criteria

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

Select...

I have long-term kidney problems.

Select...

I have high blood pressure in my lungs or liver due to cirrhosis, and it's at least moderate in severity.

Select...

I have recently developed a heart condition affecting the left side.

Select...

I am not on any long-term medications that are not allowed.

Select...

I have a serious heart rhythm problem that could be life-threatening.

Select...

I have ongoing high or low blood pressure issues.

Select...

I do not have any untreated serious infections.

Select...

I am using inhaled medication for blood pressure in my lungs.

Select...

I regularly take blood thinners like warfarin or NOAC/DOAC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 80 months or availability of commercial product

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 80 months or availability of commercial product

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 80 months or availability of commercial product for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)

Side effects data

From 2022 Phase 2 trial • 86 Patients • NCT04456998

43%

Cough

14%

COVID-19

14%

Headache

14%

Diarrhoea

11%

Dizziness

11%

Nausea

11%

Fatigue

Nightmare

Dyspnoea

Nasopharyngitis

Nasal congestion

Throat irritation

Abdominal pain lower

Rash

Arthralgia

Back pain

Chest discomfort

Vomiting

Appendicitis

Pneumonia

Staphylococcal bacteraemia

Vascular device infection

Lymphoma

Squamous cell carcinoma

Right ventricular failure

Jugular vein thrombosis

Haemoptysis

Pleural effusion

Pulmonary arterial hypertension

Enteritis

Obstructive pancreatitis

Device malfunction

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

GB002 (Seralutinib)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GB002 (seralutinib)Experimental Treatment2 Interventions

GB002 (seralutinib) inhaled orally twice per day (BID)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Generic Dry Powder Inhaler

2020

Completed Phase 2

~160

GB002 (seralutinib)

2020

Completed Phase 2

~90

0 / 10Eligibility 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

Common treatments for Pulmonary Arterial Hypertension (PAH) include phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, endothelin receptor antagonists (ERAs) such as bosentan and ambrisentan, and soluble guanylate cyclase stimulants like riociguat. These treatments work by targeting different pathways to reduce pulmonary vascular resistance and improve blood flow. PDE5Is increase nitric oxide availability, leading to vasodilation. ERAs block endothelin-1, a potent vasoconstrictor, reducing vascular tension. Riociguat enhances the nitric oxide signaling pathway, promoting vasodilation and reducing vascular remodeling. These mechanisms are crucial for PAH patients as they help alleviate symptoms, improve exercise capacity, and potentially slow disease progression by addressing the underlying vascular changes and inflammation characteristic of PAH.

Retraction: CD248 as a novel therapeutic target in pulmonary arterial hypertension.