RE:New Analyst update calling AGN.C a SPEC BUY with $25 target Screenshot didnt work
Breathing Easier - Liftoff! - IPF Phase 2a Data Hits ACTION: Maintaining SPECULATIVE BUY Rating and Target Price AGN reported topline results of a Phase 2a trial with ifenprodil in IPF patients with chronic cough - the idiopathic pulmonary fibrosis (IPF) data hit its endpoint -showing promising initial efficacy. We are maintaining a SPECULATIVE BUY rating. Our target price of C$25.00 is based on a probability-adjusted NPV analysis of ifenprodil.
DETAILS: Topline Phase 2a Results with Ifenprodil in IPF Patients with Chronic Cough Design of the Trial: This open-label study enrolled 20 idiopathic pulmonary fibrosis (IPF) patients with chronic cough. Each patient received 12 wks of ifenprodil treatment (20mg, 3 times/day). The primary endpoints are as follow: (i) reduction in 24h and waking cough counts for the cough indication, specifically, a ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor at week 12 & (ii) forced vital capacity of the lungs for the IPF indication, specifically, no worsening of force vital capacity (FVC) in either mL or % predicted at week 12. Key secondary endpoints included biomarkers of fibrosis.
IPF Data Hits Primary Endpoint: In order to understand the potential efficacy in IPF patients, lung function in this trial was measured by forced vital capacity (“FVC”). Forced vital capacity (a best-efforts measurement) was taken for each patient at baseline, and then again at 12 weeks. Patients whose FVC declined were classified as non-responders, while those whose FVC improved were classified as responders. Of the 20 patients who enrolled, 13 (65%) had improved FVC over the 12-week treatment period with statistical significance (p=.0225 when compared to an anticipated placebo effect of 40%, all numbers are Intent-to-Treat analysis). The primary endpoint of the IPF part of the study was the proportion of patients who achieve zero reduction in lung function at 12 weeks vs. baseline. It should be noted that an ITT analysis was conducted in 19 out of the 20 patients, as one patient did not have week 12 measurements (that is, one patient died – unrelated to NP-120 “Ifenprodil”). Importantly, KOLs advising the company had indicated prior to these results that approximately 30-33% of patients IPF patients would experience no decline if they were dosed with a placebo over the 12 week period, thus this data indicates NP-120 showed promising initial IPF efficacy in this trial.
IPF With Chronic Cough Misses Primary But Has Potential: For the chronic cough part of the study’s primary endpoint, 35% of subjects achieved the endpoint of a 50% reduction in the average number of coughs per hour over 24 hours from baseline to week 12. While this primary cough study endpoint did not achieve statistical significance (p=0.3017 when compared to an anticipated placebo effect of 25%), the secondary endpoint of actual changes (reduction) in cough counts did. Subjects experienced a 24% relative reduction from baseline in mean cough count, and a 38% relative reduction from baseline in median cough count in their 24-hour cough count per hour at week 12 (p=0.0344). In addition, 75% of subjects saw improvements in their cough over 12 weeks. There is potential to redesign a trial for this indication as all patients showed an improvement regardless of their baseline cough count.
IMPACT: A High-Risk/High-Reward Investment Opportunity AGN is incredibly undervalued having a market cap of only $6M. AGN’s ifenprodil has a well established safety profile and now promising initial IPF Phase 2a data - for an Orphan indication that is targeting an unmet medical need for a very large market opportunity. We are maintaining our SPECULATIVE BUY rating and target price of C$25.00. We expect AGN to trade up on these positive results. We recommend investors with a higher risk tolerance to aggressively purchase the stock.