Back in 2003, I wrote about the excitement over PYY3-36, a peptide which showed some profound effects on feeding in animal models, but I wasn't exactly jumping up and down:
. . .You're not going to be able to take this orally. It's going to be i.v. or bust for some time, I'm afraid. There's some hope for taking peptides of this size nasally, although it's tricky, and there's an outside chance of getting them through via a transdermal patch, but I wouldn't bet on that one. . .And these are early days. The obesity field is cluttered up with promising ideas that have deflated. . .
A small company called Nastech took a whack at the idea, using the nasal delivery route, and they had some promising Phase I data. Well, OK, Phase I isn't designed to show efficacy, but they looked anyway, and saw some. In the eleven patients who completed the study, that is. Well, OK, in the nine responders. But the data were interesting enough to get Merck on board to fund some real efficacy studies.
Well, the results are in, and the headline says it all: "Nastech Pharmaceutical Company Reacquires PYY3-36 Nasal Spray. . ." is how the press release starts, and you know what that means. The stuff missed its endpoints most powerfully, and Merck hit it back over the net. Makes you wonder what the deal was with the positive human data that had been reported by others back in happier days, doesn't it?
Nastech makes what they can out of the blood levels they observed, and says that they hope to take the peptide back into Phase II once they've worked out a better dosing regimen. I wouldn't stand on one leg while waiting for that happen, but I wish them luck. There may be other indicators over the next few weeks or months. As Fred Cohen points out, Amylin is also working on the same peptide with an injectable dosing protocol, and if you see them pulling out of the field then that's going to be that.
Perhaps the saddest paragraph in the Nastech release is this one:
Nastech intends to cooperate with Merck in the production of a manuscript to be submitted for publication concerning the clinical trials performed by Merck. Merck noted that the 'interaction between Merck and Nastech has been positive and professional', and that they 'would welcome the opportunity to collaborate with Nastech again should the appropriate opportunity arise.' Nastech as well would welcome the opportunity to work with Merck in the future.
I'll bet that they would, and I hope that they get the chance. For now, it looks like this work is going to go to where drug development projects go when they die: publication in a peer-reviewed scientific journal. For industrial scientists, that's a sad way for things to end. The obesity field may have yet another failed hypothesis to deal with; you'd think that it already had ruined enough for anyone.