Clinuvel Pharmaceuticals (OTCPK:CLVLY) is expecting to report on key binary events in the coming months – and as of right now, these binary events are flying under the radar in the biotech investing world. This presents an intriguing opportunity for those investors who are looking for a high risk / high potential reward play in biotech.
These events will be game changers – and they are all right around the corner. Let’s preview them:
1. Results from the Phase III EPP trial –
Clinuvel is banking on solid Phase III EPP (porphyria – absolute sun/UV intolerance) results from the current trials in Europe and Australia. The EPP trial is their lead trial for their first-in-class photoprotective drug, afamelanotide. Results are expected in within three months. Positive results will significantly de-risk the Company and should spawn several more accomplishments soon, such as trials in the US and a trade name for afamelanotide.
Note that in January 2009, the Company reported positive interim Phase III results for EPP.
2. Interim results from the Phase III PLE trial –
The PLE (polymorphic light eruption – sun/UV poisoning) indication for afamelanotide holds the largest potential on-label market for the drug. I’m personally putting more weight on the results of this trial than others are. If the PLE trial does not meet its primary endpoint, I would consider this a pretty big blow to the Company. Given there are a handful of clinical indications for afamelanotide, disappointing PLE results would not be deadly, but would certainly have a negative effect on shareholders.
Interim PLE results are expected in Q4 2009.
3. FDA Green Light for a USA Phase III trial –
It appears the Company is waiting for the FDA to grant clearance for a confirmatory Phase III EPP trial. Approval of this trial would be a watershed event for the Company for a couple reasons:
First, the Company would finally be on path to starting a major trial for afamelanotide on American soil, roughly 20 years after the synthetic version of the melanocyte stimulating hormone was first created by researchers at the University of Arizona.
Second, it is extremely rare for any Australian biotech company to achieve late-stage drug trial status with the FDA. The Company would be on path to entering the largest pharmaceutical market.
Clinuvel is hoping to begin a Phase III EPP confirmatory trial in Q2 2010.
One thing is for certain – Clinuvel Pharmaceuticals is about to enter the most important 3-4 month period of its history. The above-mentioned binary events will determine much of the Company’s fate.
Disclosure: Long Clinuvel