Corbus Pharmaceuticals (CRBP - Get Report) waves a sea of hands in front of investors' eyes Thursday to obscure dismal results from another mid-stage study of its experimental anti-inflammatory drug anabasum.
In this four-month study of cystic fibrosis patients, the Corbus drug failed to improve lung function compared to a placebo. Overall respiratory symptoms, measured by a cystic fibrosis patient questionnaire, also showed no difference between anabasum and placebo.
These were the two most important, prospectively defined efficacy endpoints measured in the Corbus phase II study. Both came back zero. No benefit.
Instead of dealing with the clinical setback honestly, Corbus deflects with cherry-picked "positive" results from subsets of patients using endpoints not even written into the original design of the study.
Corbus claims a subset of patients treated with the highest dose of anabasum -- 20 mg taken twice daily -- reported a 75% reduction in "acute pulmonary exacerbations" compared to a placebo.
A 75% reduction sounds impressive but it wasn't. There was a one acute pulmonary exacerbation in patients treated with the 20 mg twice daily dose of anabasum compared to three of these events in placebo patients. In other words, Corbus got lucky with a tiny number of events.
Worse, this tiny numerical difference is probably due to imbalance in the baseline characteristics of patients in the study. Notably, significantly more patients in the 20 mg twice-daily arm were being treated with Vertex Pharma's (VRTX - Get Report) cystic fibrosis drugs Orkambi or Kalydeco compared to the placebo patients. The Vertex drugs are proven to reduce pulmonary exacerbations.
Corbus defines "acute pulmonary exacerbation" events as those requiring intravenous antibiotic treatment. The company claims these data were "captured as an event of special interest during the study."
The study, as originally designed, does not include "acute pulmonary exacerbation" as a prospectively captured efficacy endpoint.
Six placebo patients compared to seven anabasum patients reported treatment-emergent pulmonary exacerbations in the study. Corbus' drug performed numerically worse.
Corbus insists Thursday's anabasum results from the cystic fibrosis study are "exciting," "promising" and "encouraging." The study was too short, too small, to identify the true clinical benefit of the drug, the company claims. Corbus offered similar platitudes last year with a phase II study of anabasm in sclerosis.
These are lame excuses that only make sense if you ignore all the objectively negative data and turn off your brain. Smart investors won't do that.
Editor's Pick: This story was originally published on Wednesday, March 30, at 9:04 a.m.