I actually think that FX-322 showing results may bring more money to the hearing space when investors see the market potential for hearing restoration. Same thing happens in other non-medical industries.
This is the only one I'm aware of where a placebo group was involved:
Thanks for finding that!
Wow, even in that study the placebo effect is really high. I wonder if just the act of doing the injection somehow helps relieve the symptoms of Ménière's. Maybe it helps some fluid leak out of the inner ear (which I've heard contributes to the disease). I wonder if the placebo effect would still be as high if the control group was given a sugar pill instead (and made unaware that the other group got an injection).
Looks like the 6 month mark is when placebo and steroid start to differ appreciably.
This is probably exactly what has happened. However the same thing could happen with other treatments like FX-322 if they need to reformulate the medicine. I reckon that this is not a bad thing that they are doing this now because it will mean that the end product gives people the best chance of a positive and successful outcome possible.
The drug, Otividex, was designed to treat vertigo in Meniere's patients using a steroid delivered intratympanically. It got to Phase III but failed twice because it didn't show enough improvement over placebo on either occasion.
I'm no expert, but I read that the trials for tinnitus were successful last summer so they are focusing on that now.
Otonomy had a drug rarely discussed here called Otividex. It was an extended release steroid for Meniere's being tested for vertigo episodes. It did not meet its endpoints.
Because vertigo in Meniere's is extremely subject to the placebo effect. In one study that @Aaron91 posted, 57% had full remission for a year with placebo. Vertigo episodes were Otividex's only endpoint.
My theory: it probably doesn't help vertigo from other causes, but in Meniere's specifically elevated intracranial pressure seems to be related to hydropic attacks and stress can elevate intracranial pressure.
. With that said, don't you think their balance sheet of almost $85m gives them enough working capital to make a go at their other pipeline drugs?
I think people are scared of their ability to keep taking hits. If OTO-413 is a booming success (thankfully, the first Phase 1/2 was really positive so the next one probably will be as well), there's less to be worried about, but what if they have to redo a deeper phase (much like OTIVIDEX)?
Very good points, and the failure in this latest Phase 3 is a real head scratcher. After looking at the latest 13F's (institutional investment) they really "piled on" in the last quarter, so there were many believers they would crush Phase 3. I think what's going to be very important to keep these institutions from losing faith and heading for the hills would be as you pointed out the ITT vs PP assessments. This will allow the company to identify if it was only a few patients that drove the ITT vs PP results or was it all 12 patients. My thought is if there are logical explanations, it may allow them to save faith and maintain investor confidence that they are able to finally execute successfully.
Well, they're saying they have enough cash balance to achieve clinical readouts, but for which phases?
Well, you can assume with favorable Phase 2 readouts, more cash investments will be made. Without favorable readouts, though, they don't have drugs anyway.
The relationship between CSF pressures and inner ear pressures in hydrops suggests that intra-aural fluid pressures are elevated in the hydropic ear.
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