The wonderful Bellus story: not ours.2 very different stories. those of Bellus' chronic cough medicine and Spectral Medical's septic shock treatment.
BLU-5937 phase 3 trial
Randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study
First patient expected to be enrolled in the fourth quarter of 2022;
Topline results from CALM-1 expected in 2H 2024
And that's for 675 patients (no problem finding patients)
160 sites
For a drug that would be very widely used to treat a chronic condition suffered by millions.
The company was bought out a few months after the start of the phase 3 trial (interest was there).
Tigris phase 3 trial
No end in site (started in 2019)
50 patients randomized over 150 during that time.
Open-label study designed to find a sub-sub-sub group of septic patients that might statistically benefit from PMX.
The medical community and patients seem very reluctant to use this treatment.
(cannot find participants in the US, PMX is approved in Canada and not used...)
Not a stand-alone treatment (to be administered in addition to SoC), which means very expensive and highly likely insurance companies would not be inclined to reimburse.
Who knows what will be considered a success leading to an FDA approval?
Company always fails to meet targets.
Company nerver seizes the chance of selling its product.
Company wastes money.
Company gives out its assets.
Shady management behaviors (conference calls, communiques, share handouts)
We can stop using the "millions of people worldwide", as we do not have PMX rights for outside NA.