Kinarus Therapeutics, a Swiss clinical-stage biopharmaceutical company, announced preclinical data supporting the effectiveness and safety of KIN001 for the treatment of idiopathic pulmonary fibrosis (IPF) and revealed a protocol plan for a phase 2 clinical trial.
In a mouse model of lung injury, KIN001 demonstrated high efficacy at reducing the weight of lungs and tissue fibrosis score. The novel oral therapy was more effective than the present standard of care, pirfenidone, while the combination of the two showed an even greater reduction in lung fibrosis.
“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 or combination therapy,” said Thierry Fumeaux, chief medical officer of Kinarus.
“Our data demonstrate that KIN001 possesses broad anti-inflammatory and anti-fibrotic properties which increase the probability that a patient may respond to KIN001. Together with our superior safety profile, demonstrated in clinical testing to date, this indicates that KIN001 may be more effective and better tolerated than available drugs.”
Fumeaux noted that patients with IPF often stop taking the drugs that are currently available because of side effects and lack of efficacy.
According to the plan, the phase 2 study will be a 52-week, double-blind, randomized, placebo-controlled trial assessing the effect of KIN001 on forced vital capacity (FVC) in 80 patients with IPF. The study will include patients receiving pirfenidone and nintedanib as well as those not receiving any current standard medication.
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KIN001 is an orally administered combination of pamapimod and pioglitazone which might significantly reduce the upregulation of multiple key inflammatory cytokines and chemokines implicated in the pathology of lung fibrosis.
The biopharmaceutical company is currently conducting a phase 2 trial evaluating the ability of KIN001 to reduce the severity and duration of COVID-19 symptoms in ambulatory patients with a positive SARS-CoV-2 test. The preclinical data “also support the potential of KIN001 to reduce the severity and long-term organ damage in COVID-19.”
Kinarus Therapeutics reports preclinical data in lung fibrosis and discloses clinical development plan. News release. Kinarus Therapeutic Holding AG; January 17, 2023.