Interesting news, actually.
I saw this. IPIX is considering improving Brilacidin contact time with sachets. That's taking a page from Validive playbook (mucoadhesive buccal tablet). Put that on top of this fact: besides Kepivance's registration trial where mysteriously near 100 % of placebo subjects developed serious OM (a Secretariat at Belmont 1973 like feat: not equalled, or even approached since) ...a big pause ...
At 0.71 Brilacidin has the lowest known hazard/risk ratio vs placebo in severe OM among approved and experimental treatments. I base this on IPIX reported mITT population. IPIX 'per protocol' would have even better ratio, but who knows how that population is defined.
Hazard/Risk Ratios for severe OM incidence in recent trials:
Kepivance, 180 ug/kg in FDA approval blood cancer trial: 0.67
Bricalicin,45 mg/15 ml in p2: 0.71
Validive, 50 ug in p2: 0.73
Kepivance, 180 ug/kg in head and neck cancer, p2: 0.76
Kepivance, 120 ug/kg in head and neck cancer, p2: 0.78
Validive, 100 ug in p2: 0.80
Kepivance, 180 ug/kg in supporting p2 for FDA approval: 0.84 [1]
Dusquetide, 1.5 mg/mL in p2: 0.94
[1] with identical dosing and schedule as in the pivotal p3 trial (why do we still wonder why Kepivance is losing indication scope?)
My ab culus hazard ratio range prediction for Brilacidin is 0.66 to 0.79 unless IPIX can convince me that their per protocol population has relevance to FDA. A quick calculation for sufficient trial size gives minimum 190 OM observations (if you believe HR will be at most 0.66) to maximum 480 (if you are afraid HR will be as high as 0.79).
Now, improved contact time would probably push numbers down (HR and populations needed) making Brilacidin even more inviting. And a sachets looks like the easiest/fastest way to improve contact time.
It took few days to hunt down all references and calculate the ratios. My guess is that the so-called interested pharma has had a similar comparison since the day IPIX published results.
Warning: the exists evidence that I can be SOOOO... WRONG!
