Investment Highlights

• FDA provides validation for ‘4050 in IPF. We had viewed the pre-clinical data for

PBI-4050 to be very supportive of its applicability in IPF. However, we believe that the

FDA’s buy-in for a pivotal clinical program in IPF provides tremendous validation in this

indication, which may prove to be the largest blockbuster opportunity for PBI-4050.

• Visibility of an abbreviated path forward. The ‘green light’ to file the IND with the FDA

in IPF provides a clear path forward with the potential to reduce development timelines

substantially. This could allow investors to see Phase III clinical evidence in IPF much

sooner than expected and also reduces regulatory risk, in our view.

• Potentially a more attractive asset to big pharma. The FDA has agreed to allow

ProMetic to evaluate PBI-4050 as add-on therapy to the existing standard of care

(either pirfenidone (Esbriet) or nintedanib (Ofev)). Based on the observed synergistic

effect of ‘4050 in combination with pirfenidone in preclinical studies, we believe that

this could significantly reduce clinical risk. Armed with the FDA’s blessing, lower clinical

and regulatory risk, as well as a shortened development timeline, ‘4050 could now be

an even more attractive asset for big pharma.

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comments from PLI's IR (Fred):

Tks and you’re absolutely right with the fact that it is good news, it’s actually great news and significant for the following reasons:
 
The FDA is allowing ProMetic to file for an IND in the USA on the back of its non-clinical data
 
•           This confirms how impressive the pre-clinical data on PBI-4050 in the lung fibrosis models is;
•           This confirms that the combination of PBI-4050 and pirfenidone in the pre-clinical model is also impressive;
•           The safety profile in humans (healthy volunteers and patients) to date is also remarkable;
•           This confirms a regulatory pathway for PBI-4050 as an “add on therapy” to the existing standard of care.
 
Now ProMetic has three shots at the goal for IPF: PBI-4050 in combo with pirfenidone, PbI-4050 in combo with nintedanib or PBI-4050 alone.
 
Overall, this accelerates the IPF program as ProMetic does not need to first secure evidence of efficacy in the current Canadian Open label phase II multicentre trial (that was also expected to be expanded in the US). 
 
ProMetic can now proceed and file the IND for the placebo controlled pivotal study in the US. This shaves over 12 months in the development program timelines.
 
World experts are currently drafting this protocol based on the FDA input.  The design may allow the study to show a difference between treatment arms in as little as 6 months.
 
Just to further add to the fact we do not know just yet how long it will take before we get to see results from this upcoming pivotal trial. I’ll know more once we have filed the IND (Q1 2016), have the IND cleared by the FDA (normally 30 days after filing) and see how quickly enrolment of patients will proceed.
 
As mentioned, we’re currently finalizing the protocol to file the IND in Q1 2016. We will be powering the study enough to show statistical difference in possibly as little as 6 months of treatment. Proof will be in the pudding Bob. The nice message is that we have basically shaved about or even more than 12 months of development time with this…
 
 
Tks
 
Fred