Do we really think BOT management would try and ‘bury’ results of the psoriasis BTX1308 trial? Or hope that no-one was going to ask as shareholders basked in the glory of the exciting news – or were simply too dazzled by Vince’s smile to care.
What benefit could there be in burying the results of an initial Phase 1 trial? It is ultimately an early, exploratory investigation amongst a very small number of trial participants – typically aimed at determining safety and dose response – but potentially some indication of efficacy as well.
Surely not releasing results would be as damaging – if not more damaging – than releasing what may be interpreted (by the market more so than the medical community) as ‘disappointing’ results? Trust in management would be eroded irrevocably.
The Phase I trial design was clearly articulated – and does have efficacy relative to placebo and a relatively potent corticosteroid (Betnovate 0.1%) - as primary endpoints. These are the primary and secondary endpoints and comparators as per ANZCTR website
As noted already - the different treatment arms are also mentioned explicitly in the announcement.
So, one can only assume that results are still to be released. How many times do we need to read the term ‘interim’ to understand this?
The only question in my mind is the strategy management may be adopting around the release of the results. And perhaps a less than ‘dazzling’ set of results needed to have the precursor of more significant ‘news’ regarding the potential mode of action of cannibidiol in dermatology.
Results generated from 15 trial participants – and across a very short time period for psoriasis (19 days) should surely not be taken as a definitive indicator of likely efficacy. And a pretty tough call to compete with a steroid cream that is known to work in the short term - but probably shouldn't be used long term, and certainly not by children. But the market being the market – any hint of anything other than “We smashed it out of the park” can be met with – at best – a muted response and – at worse – a drop in the SP. ‘Missing’ a primary efficacy endpoint in Phase 1 should mean nothing in terms of the clinical potential for the product – but it would impact the SP if misunderstood by or miscommunicated to the market.
(As an aside – one of the pivotal trials for Abbvie’s new biologic for psoriasis was studied over 16 weeks to determine efficacy. Whilst biologics are typically trialled in severe psoriasis patients – a longer trial across a larger population is probably very necessary given the highly variable nature of psoriaric symptoms – which can ‘come and go’ as patients experience ‘flares’.)
So – releasing a very positive set of results / announcement around the likely mode of action of BTX1308 which includes emphasis on the IL6 and IL13 target pathways places the product ‘front and centre’ in the management of psoriasis – and potentially de-emphasises the need to focus on how around a dozen punters went on BTX1308 for a few weeks. IMO this is important and significant news - regardless of the treatment outcomes in the trial.
The current biologics for psoriasis – of which there are many – all ‘compete’ by referencing where in the disease pathway they work –IL23, IL17 etc.
BTX1308 is now part of that conversation.
And at the same we learnt that cannabidiol has antimicrobial properties – even if there was / is some confusion evident in having these two announcements so close together.
But the strategy of emphasising combined antimicrobial and anti-inflammatory properties points towards the de-risking of the next most important trial – Phase II Acne trial
And let’s not forget Phase II is the toughest hurdle for any new treatment (with average success rates of around 39%).
So far management has played this beautifully. Why would I start to mistrust them now?
[All just IMO / DYOR / etc]
(20min delay)
