I jumped into one of the Incannex zoom meetings yesterday.
Joel made himself completely available for discussion and questions. After the presentation, he fielded questions and made clear he was there to answer everything we might have questions about, without setting any time limits on the interactions.
IHL-42x
I mainly asked about Apnimed, and whether their FDA fast track and pending start of Phase 3 represented a serious challenge to IHL-42x.
Joel explained that their AD-109 had seen their proposed 6 month Phase 3 trial knocked back by the FDA: instead they must complete a 12 month Phase 3 trial. This trial has not started yet. This puts us basically neck to neck in terms of timeline, as our blended Phase 2/3 trial is poised to start and will run for 12 months. It sounded like the FDA wanted longer safety data from AD-109 because of the serious side effects one of their active ingredients (atomoxetine) is documented as producing (including suicide, cardiovascular damage, severe liver damage, erectile dysfunction and more). These potential side effects have earned it a 'black box' warning. The dosage of that ingredient in their combination drug is lower than the amounts usually prescribed for its primary indication (ADHD), but barely so. (75mg in AD-109, vs 80mg in Strattera, for adults). Clearly it was enough to give the FDA pause and we'll all be watching the results of their trial closely as they become available, to see if any of those serious issues rear their head. The likelihood is pretty high.
More common side effects, as has been already noted here on HC, include dry mouth, nausea, constipation and insomnia. And yes, all on its own, the irony of suffering insomnia in the pursuit of better sleep quality might be reason enough for doctors to try IHL-42x with their patients first, before thinking of AD-109.
As previously noted, we expect a significantly better side effects profile for IHL-42x, although only time will tell. Certainly the limited data from our Phase 2b warrants some of this expectation, as does the profile of the two active ingredients of our combination therapy, neither of which have 'black box' warnings associated with them.
Our 505(b2) pathway is slightly different to Apnimed's fast track, but delivers similar perks in how the FDA streamlines our drug candidate's process.
So in summary:
- neck to neck on the FDA timeline
- comparable efficacy
- but quite significant side effects profile for our IHL-42x.
If that holds true through to commercialisation, it should be enough to make IHL-42x the first choice.
As an aside, even if for some reason that is impossible to determine at this point in time, AD-109 carves out 70% of the market and IHL-42x only 30%, investors should keep in mind the OSA TAM is about 10 billion, vs (I believe)n the 1 billion TAM Epidiolex hoped for during development... GW Pharma sold for 7.2 billion USD, overwhelmingly for their lead asset, Epidiloex. In other words both Incannex and Apnimed could come out of this sitting very pretty indeed.
IHL-216a
Joel reiterated that IHL-42x, IHL-675a, Psi-GAD and three APIRx assets will be prioritized for the moment, and IHL-216a will either wait for the company to have a larger war chest, or for a collaboration. Useful news though: Joel confirmed that the work with Curea on developing the IHL-216a formulation, first GMP batch and stability testing has gone very well and will be complete in the coming weeks. Incannex will announce the completion of that work to market. The asset will then be ready to enter into clinical trials once the right time arrives. Apposite to this is the impending hiring of a dedicated manager in the US, whose role will be to seek out collaborations to progress and monetize as many of the 22 other drug candidates Incannex owns IP for that will not be being put through clinical trials by the company in the short term. That includes IHL-216a.
Joel also noted that IHL-216a was by far the most expensive of their drug candidates to put through clinical trials, which goes a long way to explaining their strategy with this very promising drug candidate.
Last tid bit: I asked Joel which drug candidate Bob Clarke had been the most impressed with, if any, and that may have tipped his decision to join Incannex after 4 months of stringent due diligence. Joel said without any hesitation: hands down, IHL-42x.
Good luck all holders.
I will be voting YES for the move from ASX to NASDAQ, and keeping an eye open for a buying opportunity in the coming weeks before the move, and as cash becomes available to me.
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