Phase 2 Trial of NP-120 for IPF Reaches 25% of Enrollment Target

Teresa Carvalho, MS avatar

by Teresa Carvalho, MS |

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Phase 2 study of NP-120 (ifenprodil)

A Phase 2 study of NP-120 (ifenprodil) for chronic cough associated with idiopathic pulmonary fibrosis (IPF) has reached 25% of its enrollment target, Algernon Pharmaceuticals, the therapy’s developer, has announced.

“I am very pleased to report that we have reached 25% enrollment in the study,” Christopher J. Moreau, CEO of Algernon, said in a press release.

“IPF and chronic cough are very serious conditions … and our team is working hard to make sure our clinical program of investigating Ifenprodil as a possible treatment continues to move forward on schedule,” he added.

People with IPF often face a persistent cough, which affects their general health and quality of life. However, there is no approved treatment for this symptom and those used off-label usually do not provide the desired effect.

NP-120 is an antagonist of the NMDA receptor glutamate that also binds to a protein called the sigma-1 receptor. Both receptors have been implicated in tissue scarring (fibrosis) in the lungs.

Previous studies showed that NP-120 has an anti-inflammatory effect and can reduce fibrosis in the lungs of a mouse model of IPF. In another study in a guinea pig model of acute cough, NP-120 significantly delayed the onset of the first cough episode and reduced cough frequency.

The new Phase 2 study (NCT04318704) intends to assess the safety and effectiveness of NP-120 in preserving lung function in people with IPF and in treating cough associated with the disease. Enrollment is currently open in Australia and New Zealand. Additional information on contacts and sites can be found here.

The trial aims to recruit 20 patients up to 85 years old. Participants will receive 20 mg of NP-120, to be taken orally three times a day.

The primary goal of the trial is observe a decrease of 50% or more in the average number of coughs over 24 hours. Researchers will also evaluate whether patients experience a worsening of their lung function during treatment — assessed through their forced vital capacity (FVC).

As recently reported, the study has received ethics approval and successfully completed site initiation at three locations in Australia and two in New Zealand.

Algernon is currently also working on an injectable and slow release formulation of NP-120.