Where others have failed will Atl1102 succeed ?, page-69

Hi @Uboy

I for one am not expecting one big trial, on saying that

Yes i believe the trial results from both trials will be acceptable by both governing bodies in either direction

Reason i believe they will be separate

1 . The EMA route is to close to starting it is way way in advance of any FDA route at this moment in time

2. It would put us at a disadvantage in partnering discussions because there is no way we would be able to fund a trial of this size, separate trials, gives us the edge in partnering talks, we will be starting this trial October onwards this year, some 15 months later hopefully we will be talking marketing approval through the EMA with the ongoing extended trial to back in the marketing application

3. The route above puts any large Pharma under pressure to cough up the Big $$$$ now or miss the boat, like i have said, more than one way to skin a cat. If know one wants to cough up then like i said one would hope plans are being made to face that challenge and again as i have said look to listing on the Nasdaq with a $70mil + IPO.
This should not be a problem raising support if our US directors are up to it. Everyone keeps saying they have been there before done that,

Well as they say

SHOW US THE MONEY, SHOW US YOUR MAGIC

4. Again as i have previously said they would be insane not to include ambulant children in this trial so just right there the dynamics of the trial would not marry up but on saying that i am sure if we go down this track then as i said above, i am sure that any trial carried out through the FDA route would be accepted by the EMA hence, we would have the advantage of being able to go it alone in none ambulant and early access to market.

But once the larger number more involved trial through the FDA, carrying both the ambulant and none ambulant children is hopefully a success, this would, along with the new data hopefully allow us to cross combine our data and thereby allow us to treat the Ambulant children under the flag of the EMA

This would bring in added value that we have not had to budget for in our original trial, and if in a partnering situation through the FDA, the partner would have funded that added value that we would receive by adding Ambulant children to our existing marketing approval for None ambulant children under the EMA banner

Backing up the truck a little here and going closer to home with regards to the Minutes we are awaiting on

Lets not forget here the reason for the type c meeting

The type c meeting once more

The Company with its US based expert regulatory consultants is clarifying via the meeting the preclinical requirements to support the clinical development of ATL1102 in the US in DMD patients and expect to conclude with guidance on the path forward.

As part of its Type C meeting, the Company is requesting that the FDA consider allowing the data from previously conducted 6-month monkey toxicity studies, and recently obtained 6-month (24 weeks of dosing) clinical safety data in non-ambulant DMD patients, to support the longer term (12-month) dosing of ATL1102 in DMD patients in the US.

Please take note
This was a 1 hour meeting giving us the FDAs requirements to support the clinical development of 1102 moving forwards,

So i am expecting just that guidance

So looking for Tox and existing trial decision acceptable or not, ( if not the requirement to move forwards )

We could also find in these minutes, what with the talk on other indications that the anp will be asked to look at combining 1102 as a multiuse drug and in doing so apply it to the following

possible new indications that may be applicable to ATL1102 drug development

AS IN

The method of claim 1 wherein the MD is selected from the group consisting of

Duchene muscular dystrophy (DMD),
limb girdle muscular dystrophy (LGMD),
Becker muscular dystrophy (BMD),
congenital muscular dystrophy (CMD including Fukuyama Type congenital MD and congenital MD with myosin deficiency),
fascioscapulohumeral, oculopharyngeal, Emery-Dreifuss, and distal muscular dystrophy.


[0006] Muscular Dystrophy (MD) is a group of disorders characterized by progressive weakness and wasting of specific muscle tissue (myonecrosis) and replacement of skeletal muscles with fibrous, bony or fatty tissue. There are several different forms of muscular dystrophy affecting either males or males and females, many of which appear during infancy and childhood up to middle age or later. The form and severity vary with age of onset in particular, with younger subjects often experiencing acute progressive disease. The most common forms of MD are Duchene muscular dystrophy (DMD), limb girdle muscular dystrophy (LGMD), Becker muscular dystrophy (BMD), congenital muscular dystrophy (CMD including Fukuyama Type congenital MD and congenital MD with myosin deficiency, fascioscapulohumeral, oculopharyngeal, Emery-Dreifuss, and distal forms. Almost all types of MD arise from single-gene mutations.


Something like the feedback IHL just received from the FDAin their recent minutes see below

Following guidance from FDA,

Incannex is delighted to report that it will expand its development program to assesses the potential for IHL-675A to become a multi-use pharmaceutical drug. IHL has received positive pre-clinical results from five distinct in vivo assessments of IHL-675A applicable to various disorders caused by excessive inflammation. The indications prioritised for clinical assessment are:

We dont have 5 pre clinical results but we do have 2 successful Clinical trials being DMD and MS and possible relationships to the above highlighted other indications, which you could argue should give any of the above new indications the right to qualify for an immediate PH2 clinical trial without even going pre clinical,

after all, is that not what we have just done with 1102 for DMD ,at this stage in time

I am hoping that Type c turns out to be or equivalent to a Pre IND and once the advice is met to the FDAs satisfaction we can move on with an official IND submission which will get the backing of the FDA

But on saying the above i am expecting further interaction with the FDA prior to any IND Submission

Let the EMA take its course near term its our Avenue to success

Thank you Gassy and Yes we have always seen eye to eye on the potential of this pipeline

SEE HOW WE GO