AGNPF - Algernon lung disease drug hits one goal misses out on another in mid-stage study

Algernon Pharmaceuticals' ( OTCQB:AGNPF ) drug NP-120 (Ifenprodil) met one main goal but missed out on another in a phase 2 proof of concept study to treat idiopathic pulmonary fibrosis (IPF) and chronic cough.

IPF is a condition in which the lungs become scarred and breathing becomes difficult.

IPF data :

The cokpany said Lung function in the trial was measured by forced vital capacity (FVC). Patients whose FVC declined were classified as non-responders, while those whose FVC improved or remained stable were classified as responders.

Out of the 20 enrolled patients, 13 (65%) had stable or improved FVC over the 12-week treatment period with statistical significance, when compared to an anticipated placebo effect of 40%, the company said in a July 18 press release.

Data on certain serum markers which included proC3, C3M, C6M, reC1M, proC8 and ELP-3 did not reach statistical significance but trends to reduction were seen. Elevation of these markers has been linked with increased mortality and risk of disease progression in prior research studies, according to the company.

Chronic Cough Data :

In the study, primary cough main goal did not achieve statistical significance when compared to an anticipated placebo.

Algernon ( OTCQB:AGNPF ) said 30% of people achieved the endpoint of a 50% reduction in the average number of coughs per hour over 24 hours from baseline to week 12, compared to 25% on placebo.

Safety :

The company noted that  data showed that Ifenprodil's safety profile was consistent with findings from previous studies of the drug, with no new safety signals seen. About 45% of people experienced at least one treatment-emergent adverse events (TEAE). The most common TEAE’s were gastrointestinal disorders (25%) and decreased appetite (10%).

Algernon expects full data from the trial in August.

The company plans to file a pre-IND application with the U.S. FDA for a Phase 2b IPF study. For chronic cough, the company has already filed a pre-IND application with the U.S. FDA

Algernon ( OTCQB:AGNPF ) added that will take more time to review full data before a decision is made to pursue an independent phase 2b study of chronic cough or to focus on Ifenprodil as a potential new IPF drug.

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