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12:00 AM
Apr 07, 2003
 |  BioCentury  |  Product Development

Axokine neutralized

Despite meeting its primary endpoint, Phase III data from a one-year interim look at Regeneron Pharmaceuticals Inc.'s Axokine second-generation ciliary neurotrophic factor to treat obesity were a disappointment on two fronts: weight loss was less than that seen with marketed obesity drugs, and a majority of patients developed antibodies to the protein.

Indeed, despite the company's efforts to re-engineer its CNTF to reduce the antibody response, 70% of patients treated with the second-generation molecule developed antibodies to Axokine. Even so, the trial met its primary endpoints by showing that Axokine patients lost more weight than placebo patients and that there was greater than 5% weight loss in significantly more Axokine patients compared to placebo (p<0.001 in both cases).

Going forward, REGN (Tarrytown, N.Y.) is looking at new dosing regimens to give the drug a place in the anti-obesity landscape.

Why small was significant

The FDA has set a relatively low bar for weight loss. The agency suggests endpoints that demonstrate "that the drug effect is significantly greater than the placebo effect and the mean weight loss exceeds the placebo weight loss by at least 5%" and/or that the "demonstration that the proportion of subjects who reach and maintain a loss of at least 5 percent of their initial body weight is...

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