Anavex Life Sciences Corp (AVXL)

[TrueTrades]

Anavex 2-73 results methodically presented at AAIC 2016

SUNDAY
Primary endpoint:
Safety, tolerability and maximum tolerated dose (MTD) finding study.

WEDNESDAY
Exploratory secondary endpoints include: Pharmacokinetics, MMSE,
Cogstate, EEG/ERP, ADCS-ADL.

Sunday's poster reflects complete analysis of data to the 26 week mark for the PO. This is what we were looking for in March for 12 weeks but has been stretched-out to the 26 week point. That is a fantastic accomplishment by the company, in light of the thoroughness of the analysis.

Outstanding Team Anavex!!!

N=27 at 31 weeks. 4 SAEs with 3 resulting in withdrawal during the PART B consisting of:

- Delirium Grade 3: Not related
- Fractured ankle Grade 2: Not related
- Urinary tract infection Grade 2: Not related
- Hodgkin's lymphoma Grade 2: Unlikely related; Patient has developed
Hodgkin’s lymphoma. Patient’s comorbidities include Sjogren’s
syndrome, which increases the risk of lymphoma between five-and ninefold.1
Will stay on study while undergoing radiation therapy.

Look at the Safety Overview, particularly [Psychiatric disorders], and realize the correlation of these AEs to the 16 reported 'Therapeutic Response Unexpected' events outlined below it. These are the anecdotal reports reported in the Aussie pump that I mentioned could be reported as this type of AE. The adaptive design will allow for this category of events to be reported as a therapeutic response BENEFIT in-line with Quality Of Life outcome measures in the P2/3. Adaptive trial design at it's finest!

I believe this remark underlines A2-73's unprecedented safety profile:

It can be concluded that doses lower
than 50.58 mg could be tolerated by 5%
of the most frail patients, whereas,
doses higher than 70.28 mg could be
administered to 5% of the most robust
patients in the population.

The conclusions outline the PART A (5 week) results and set the stage for Wednesday's supporting data, which I bolded.

• The traditional definition of MTD was updated in the presence of
inter-patient variability. For AD patients 50.58 mg of ANAVEX 2-73 is
the maximum tolerated dose taking into account most frail patients
(5% of total patients). In half of these patients a DLT event will occur.
• In PART A, MMSE-?-, ERP-?-scores vs. ANAVEX 2-73 doses
displayed a significant positive slope for the ANAVEX 2-73 dose with
confidence intervals that excluded the zero-value.
• The MTD determination from the present Phase 2a study, allows for
a Phase 2/3 study to be conducted according to a double-blind
design including placebo. To complete the design of a future study,
population PK data (and the evaluation of inter-patient variability) are
necessary in order to compute the patients’ sample size and to
achieve conclusions associated with a given statistical power. This is
currently in progress.
• ANAVEX 2-73 may have a broader scope in addressing diseases by
virtue of both its molecular biology and the favorable safety profile
observed thus far. Estimating MTD is a prerequisite for the
progression of ANAVEX 2-73 towards further clinical trials.

They waited until 26 weeks, "so that there can be no doubt as to the cause-effect relationship of the 12-week efficacy data".

This concludes the clinical safety and dose-finding part of the mission. Wednesday we will get the matching 26-week PK/PD safety and efficacy results. We will then be armed with the necessary data to draft a protocol for FDA submission on a pivotal P2/3.

Dr Hampel makes it clear, “ANAVEX 2-73 data presented today is prerequisite information in order to progress into Phase 2/3 placebo controlled studies”

Got my bowl of popcorn ready
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