It's all getting recorded and as Ox says will be published fairly soon with the co. also saying they will put it up on the site...
But my summary - note not all words below are verbatim, some may be what I heard etc:
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PR opened well, a few quotes:
"There are no products on the market"
"Thats a massive opportunity for the company"
He started with the overview of the company and where we are i up t (Stage 1 completed).
Take away point, PAR has been able to manage its clinical programs.
We do have an opportunity to file for TGA in a couple of weeks time.
Exciting results - we have bene invited for a podium presentation and talk through the data at OARSI - new data in the treatment of OA. Commercial companies and their reps will be present at this conference.
Spoke a little about Bene. They have only FDA approved version in humans. Hasn't been able to replicated by any other company. Those other products from India and CHina have tried to get their product into US but this has not been successful (for humans).
25 year Post market exclusivity that PAR has with Bene We also know its a complicated structure and makes it a significant barrier for a true generic.
Patent portfolio.
CLINCIAL DATA OVERVIEW
005 Program (Above)
Pain Reduction and Function Improvement, placebo -v- Active
First study that PAR conducted
008 study (Above)
(Lower trending graph is better ). We go out to Day 3654, we still see from the trend a downward gradient whereas BO returning to baseline. Clinically meaningful data out to Day 365.
Function similar pattern.
Histographically, SS achieved with good separation. Post Day 56 the PBO group overall took 5 times the rescue med. as did the PPS group.
Functional effects.
Current Therapies comparison.
Mentioned about the Opioid epidemic, NSAIDS causing gastrointestinal issues
Corticosteroids and HA is intra-articular. Both of these are used more in second line.
iPPS is SubQ Efficacy increases after course and is maintained to 12 months.
PHASE 3 OA 120 sites across USA, EU, UK, Canada and Aus
Processing data
We will approach FDA based on data and interim data, dose that gives us best efficacy is 2 x 2. We will make our recommendation and subsequent IND
Couple of weeks for this deadline (to hand over data to FDA) Some external delays.
FDA asked us to est lowest effective dose. They were in agreement with the adaptive design and compare it with the 2 x 2 and go back to FDA and hopefully agree and move on with the 2 x 2 dosing.
PARA 008 STUDY
Exploratory study. Is the drug providing any modification of disease?
Case example below.
Explanation of above MRI. Fluid build up. Bone Marrow Lesion, progression of OA and remodelling. (LHS) But RHS post iPPS, Grade 3 down to a Grade 2 by Day 53. Important signal that this drug potentially doing something to address the ongoing destruction of the joint.
Most Orthopedic surgeons will tell you that OA is associated with more pain and spurs and generally wont come down. These legions are key indicators for a surgeon to suggest surgery.
Significant reduction of grade, vol, and intensity of that legion to bring it down to Grade 2.
Serum samples to measure cartilage breakdown. From baseline to follow up (day 56) we showed that these disease bio markers were decreasing.
Cartilage Thickness (increase with iPPS -v- further loss in Placebo)
Key researchers excited by this data, have seen it for the first time. They have asked us to present this to OARSI.
Complete response to Type D and revised protocols to FDA
TGA determination application also goes in a few weeks time. We hope to get green light to proceed on to full submission by July this year.
QUESTIONS
Q - Can we get a sense of when TGA app might go through and does it also cover NZ along with Aus?
I will have to speak to Reg dept about NZ coverage My understanding is AUS only but TGA prob has reach into NZ. But we will be making that application for determination within the next couple of weeks
Q3/Q4 TY for full dossier if we are allowed to go ahead after that (If we are allowed to proceed) then wait for 12 months so that's Q3/Q4 2025
MOZZ THOUGHT
Overall a brief overview and update. Didnt have a lot of time but thought he spoke well and covered it well too.
(20min delay)