Pfizer’s partners announced the results of a Phase I trial involving 114 healthy volunteers on Aug. 14. It showed COVID-19, which works by binding to COX-2 proteins responsible for inhaled tissue breakdown in Alzheimer’s disease and congestive heart failure, reduced inflammation in those diseases.
The trial included male subjects with high blood pressure, but not atherosclerosis. Only 10% of patients responded to the COVID-19. Although the full data set from the double-blind, placebo-controlled trial is not yet available, Pfizer has identified the general strength, or usefulness, of the results.
Understandably, Pfizer is eager to bring COVID-19 to the market. But that leaves its partners with a quandary: which Alzheimer’s patients will get COVID-19 first?
Who should get COVID-19?
Some eager pharmaceutical executives and shareholders expect COVID-19 to move faster than its competitors, AstraZeneca (NYSE:AZN) and Johnson & Johnson (NYSE:JNJ), can bring into the market their own COVID-2 compounds, called resolvins. Resolvins have never seen a clinical trial. Only resolvins developed by Wyeth’s Bristol-Myers Squibb subsidiary as part of a licensing deal with Bristol-Myers Squibb and AstraZeneca made it into human trials. Resolvins have been approved for certain indications like non-alcoholic steatohepatitis in patients at high risk for the disease. But resolvins for Alzheimer’s have yet to make it to the market.
While the plaintiffs in the COVID-19 case argue that both of the Pfizer compounds, COVID-1 and COVID-2, are biosimilars and thus treat the same disease, Pfizer and co-developers said they differentiate COVID-1 and COVID-2 to protect their intellectual property rights. The companies say that only COVID-1 and COVID-2 belong to Pfizer and are not biosimilars because the drugs work by targeting A4 molecules (a subset of those that found in the two other compounds). The other compounds, in contrast, have more of an umbrella effect on more A1 molecules in the patient, they argue.
That’s a complicated argument. Pfizer’s partners have not yet compiled the full data from the trial, and it’s possible that there could be several different functions to COVID-2 and COVID-1, as described by Gary Burnison, CEO of Becton Dickinson (NYSE:BDX). In addition to being a respiratory virus, that molecule can be seen as the matrix for toxic molecules in a number of diseases, such as Alzheimer’s and congestive heart failure.
So the potential competing players have identified different patient populations that their compounds might treat — and just as likely, they know more than Pfizer or their partners about those patients, who may have different symptoms. The partners are therefore free to proceed with their compounds first.
Who should wait?
On the other hand, the patients on COVID-19, which Pfizer believes are the best fits for the lung disorder indications, are thus the most important ones. Here’s why: COVID-19 appears to have two functions: it’s a respiratory virus that aims to combat the production of toxins that can cause the lung disease fibrosis, or scarring. On the other hand, COVID-2, which is also anti-infective, doesn’t appear to act on the central nervous system. And the only novel therapeutic effect from Becton Dickinson’s branded product clears the infection while it can provide molecular evidence of the therapy in protein biopsies of diseased patients.
That’s the sort of unique action that says COVID-2 represents a better therapy, at least in the lungs. The advantage of the novel action, however, belongs to Pfizer and co-developers. And if it can be shown to be the best.