Re B-OM Ph2 topline: A Lead-Off Stand-Up Double
(to use a baseball analogy)
Trial was a Success – Very Good results, imo, esp in the context that there are NO (repeat NO) effective OM treatments out there – let alone a placebo-controlled study that showed close to 30% ITT and 40% PP in PREVENTING OM, not just ameliorating symptoms. Ice chips analogy. Who wouldn't want to have a 30-40% of NOT getting OM. If I was taking chemotherapy, I'd say "Sign Me the Hell up!"
Also, note that 70% of drugs fail in Phase 2 so kudos to folks in Beverly, yet again.
The only other OM drug ever approved (Kepivance) was for Symptom Relief. B-OM is playing in an entirely different ballpark (that of Prevention), with few others (Enzychem) even targeting it as Primary. Soligenix had what a 7pt spread in Incidence and one arm actually did 7pts worse than placebo… and yet it is now in a Ph 3… with Duration/Onset the target endpoints.
Again, Context folks, Context.
Regarding BTD, how can folks say this is off the table? They haven’t even compiled all the data (Secondary/Exploratory) yet and the FDA has been throwing out FT to pretty much every OM company, like confetti, based on pre-clinical. One would think that the first drug showing true Prevention in humans would very much be in running for BTD. Go back and look at BTD criteria – language around providing a “substantial improvement” in care… and in OM, that is pretty much the lowest of bars… people are dying because of interruptions in care.
Also we are an oral-rinse, not IV – don’t discount this. In a yet untapped $1bn market where hundreds of thousands are suffering from chemoradiation side-effects.
Re dropout rate of 25% that is par for course in clinical trials. Can dig for the data if folks want, but it is what it is… esp w very sick OM patients, one might think it’d be higher.
The placebo response was a bit surp, 60% got SOM when lit shows closer to 70%... so in a larger Ph3 trial one would hope that our active-placebo spread would be even higher…. If we’d gotten closer to 30% reduction in incidence of SOM, I’d have characterized as a Home Run. Though will take a lead-off stand-up double any day.
Bottom-line: We’re standing on 2nd base with a chance to steal 3rd if we land a Partner and/or get BTD… and possibly on our way to crossing the plate as the first or one of the first -- esp in re to PREVENTION, not symptom-mitigation... though that is impt too -- OM drugs approved.
Game On.
