NUVO’s phase-2 results in acute peripheral arterial occlusion (PAO):
Despite the heady style of the data presentation, I was not overly impressed with the content. One-third of Alfimeprase patients had to be followed up surgically, the same fraction as with patients initially given an alternative clot-buster.
Moreover, the design of the trial was loose enough that it’s hard to know how many of the seven bleeding SAE’s in the Alfimeprase arm were caused by Alfimeprase. The clinicians thought it was only one, but that’s just a guess.
The PI on this trial thinks that the phase-3 Alfimeprase trial in PAO will require about 500 patients, and that won’t be cheap. If AMGN pulls out of the 50/50 partnership (a distinct possibility), NUVO will have to pay the entire freight.
Count me as a “weak sell” on NUVO.
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