Catalyst sifted through the failed results from the phase IIa study and discovered that only 40% of the patients were compliant with treatment. Patients weren't monitored during the trial and were asked to self-report if they took the study drugs. For those patients who were compliant, CPP-109 did increase cocaine abstinence and reduced overall cocaine use compared to placebo.
Armed with this information, Catalyst designed the ongoing phase IIb study to improve compliance. Patients are monitored to make sure they take CPP-109 or the placebo when scheduled. The patients were also recruited from cocaine addiction treatment centers, meaning they have a greater willingness to overcome their addiction. The company also shortened treatment duration to nine weeks from 12.
I don't know if all this study optimizing will produce positive results for Catalyst and CPP-109. I do believe CPP-109 needs to hit on more than just the primary endpoint for the results to be clinically meaningful. The follow-on abstinence endpoint is particularly important.
One note on safety: Vigabatrin at higher doses and longer exposure causes vision loss. Catalyst says the low vigabratin dose in CPP-109 shouldn't accumulate enough to cause a loss of vision, and to date, no such cases have been detected in previous addiction studies. Obviously, this is something to watch when Catalyst announces results from the phase IIb study next month.
Peter G. writes, "You should reconsider your negative articles on Amarin (AMRN - Get Report), it might have a secondary benefit other than for the heart. Someone suggested it might grow hair on bald men. Now that would be a big market for some, don't you think????" I thought insults about male baldness lost their sting 20 years ago? Seriously, look around. The only person bothered by being bald today is Donald Trump.
Sticking with Amarin, Thomas P. asks, "What happened to the Adam Feuerstein who called Vascepa 'best in class' and referred to its clinical results as 'spectacular'? Your recent parsings of supposed subtle changes in statements of the company regarding NCE status amount to a distinction without a difference. I call to your attention last year's Shareholder Letter. Zakrzewski stated then quite clearly that he thought the company had good arguments, but that he could not guarantee that the FDA would accept them. Pretty much what is being said right now. And what, pray tell, would be so awful about going it alone? It's not black and white, after all. Talks would likely continue, and perhaps intensify after the sNDA Anchor filing expected early next year, which could expand the market opportunity tenfold."