KIN001, Alone or with Esbriet, Decreases Pulmonary Fibrosis in a PF Mouse Model | Plans to bring potential IPF therapy into Phase 2 trial

KIN001, an experimental oral treatment of idiopathic pulmonary fibrosis (IPF), was more effective than Esbriet (pirfenidone) in alleviating pulmonary fibrosis in a mouse model of the disease, reported its developer, Kinarus Therapeutics.

When KIN001 was given with Esbriet, an approved treatment, the reduction in fibrosis was even greater than that seen with KIN001 alone.

Based on this initial data, the company plans to launch a one-year, placebo-controlled Phase 2 clinical trial of KIN001 in patients with IPF, including those using Esbriet or Ofev (nintedanib), also an approved treatment for the condition.

“These preclinical data strongly support the potential of KIN001 to be an effective treatment for IPF and fibrotic disorders of the lung and other organs, both in single and combination therapy,” said Thierry Fumeaux, chief medical officer at Kinarus, in a statement to press.

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Anti-inflammatory and anti-fibrotic potential seen in the treatment of IPF, KIN001

IPF occurs when scar tissue forms in the lungs. Over time, scarring (fibrosis) makes it difficult for the lungs to function properly, leading to symptoms of the disease that include shortness of breath, a persistent dry cough, and fatigue.

Although the cause of IPF is unknown, some medications can help ease your symptoms and slow the progression. However, some patients do not tolerate these treatments well and others do not respond to them as expected.

“Many patients discontinue therapy with currently available drugs because of side effects and lack of efficacy,” said Fumeaux.

KIN001 combines two active substances: pamapimod and pioglitazone. Pamapimod works by blocking the activity of p38 mitogen-activated protein kinase (MAPK), a protein that helps cells grow, move around and carry out specific functions. It appears to have anti-inflammatory and anti-fibrotic properties.

Pioglitazone is approved to help lower blood sugar levels in people with type 2 diabetes. It works by making cells more sensitive to insulin, a hormone that plays a key role in regulating the absorption of sugar into the blood.

Kinarus scientists found that the combination of pamapimod and pioglitazone makes its effects stronger and longer lasting.

In the preclinical study, researchers demonstrated that KIN001 significantly reduced lung weight and fibrosis in a mouse model of lung injury. The experimental therapy also outperformed Esbriet in reducing lung fibrosis.

The combination of KIN001 and Esbriet had a greater antifibrotic effect, suggesting that KIN001 may provide additional benefits when used alongside standard care therapies.

RNA sequencing – a technique that allows scientists to know which genes are active (on or off) in a sample – also showed that KIN001 reduced several genes that are usually activated whenever there is inflammation in lung fibrosis.

“Our data demonstrate that KIN001 has broad anti-inflammatory and anti-fibrotic properties that increase the likelihood that a patient will respond to KIN001,” said Fumeaux. “Along with our superior safety profile, demonstrated in clinical trials to date, this indicates that KIN001 may be more effective and better tolerated than available drugs.”

Phase 2 trial planned to enroll patients on standard therapies

The Phase 2 study plans to enroll up to 80 patients with IPF, including those using Esbriet, Ofev or other standard care. People who are currently not on any IPF treatment will also be considered eligible.

Enrollees will be randomly assigned to either the experimental oral treatment or a placebo. The primary endpoint of the study is changes in forced vital capacity (FVC), a measure of lung function, from baseline through week 52 using KIN001.

KIN001 is also being tested in KIN-FAST (NCT05659459), a Phase 2 safety and efficacy study in up to 400 people who test positive for SARS-CoV-2 and COVID-19 who were not admitted to a hospital. It is currently applying to locations in Germany and Switzerland.

The preclinical data “also support KIN001’s potential to reduce severity and long-term organ damage in COVID-19,” Fumeaux said.

Kinarus previously announced a possible partnership with a group in China to support the development of KIN001, including Phase 2 clinical trials.

KIN001, Alone or with Esbriet, Decreases Pulmonary Fibrosis in a PF Mouse Model | Plans to bring potential IPF therapy into Phase 2 trial

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