Today Rule Breakers pick PDL BioPharma
Nuvion is currently set to undergo phase 3 testing after getting the go-ahead from a data monitoring committee last month. Since the phase 2 study that the committee looked at is still underway, no results of the mid-stage trial have been announced yet. Today investors finally got some more trial results to sink their teeth into, and to compare with another approved ulcerative colitis biologic therapy, Remicade, from Johnson and Johnson
For a variety of reasons, including the statistical endpoints used in the data and the different patient populations in which the drugs are being tested, the Nuvion and Remicade pivotal trial results can't be directly compared. That doesn't mean that looking at how Remicade performed in its long-term study can't give an indication of Nuvion's level of efficacy, after PDL released these results today.
For example, in the one-year Remicade study, at the highest dose 37% of patients had a sustained clinical response through the end of one year. But 47% of Nuvion patients, treated in a much tougher patient population with a median 356-day follow-up after therapy, were able to avoid medical or surgical treatment (which often consists of having the colon removed).
As I mentioned before, these results are not comparable for many reasons. One reason is that Nuvion patients have already failed on many of the drugs that Remicade was being combined with in its study; this is a point for Nuvion. Also, at least half of the Nuvion patients haven't been tracked through a full year following therapy. This could lessen the magnitude of the Nuvion results once more patients hit the one-year mark, which is a point against the drug.
No matter how Nuvion's long-term results compare to Remicade, as long as PDL is able to continue to produce some sort of meaningful efficacy results for this patient population, it should have an approvable compound on its hands. Besides Remicade, there are no other biologic therapies approved for the condition, and Nuvion will be most patients' last resort before having to undergo a life-altering colectomy operation.
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