BiotechTracker - Axokine May Benefit Some
May 19, 2003. Updated phase III Axokine results presented this past Saturday at the American Society of Hypertension Annual Meeting in New York City show that Regeneron (NASDAQ: REGN) is keen to profile the subpopulations for which Axokine will have the most acceptable benefit/risk ratio. We view this as a reasonable approach, given that targeting the general population is an inappropriate clinical and commercial ambition in the development of an anti-obesity compound.  Phase III data suggest that Axokine recipients experiencing early weight loss, defined as at least 4 pounds at 1 month, were most likely to experience the greatest weight reductions after 1 year of Axokine treatment. Moreover, after 3 months of Axokine (or a weight reduction program alone) administration, study subjects who had lost at least 4 kilograms (8.8 pounds) were more successful at sustaining weight reduction after a year. Such responders have been termed “early responders,” and will be the subject of continued investigation.  Early responders in the Axokine group averaged 14.4 pounds of weight loss at 3 months and 16.6 pounds at 1 year. Early responders in the placebo group actually had a similar magnitude of average weight loss. However, a significantly higher proportion of Axokine recipients (32.2%), compared with placebo recipients (17.6%), were early responders.  The role of Axokine in the general, obese population might prove to be the facilitation of early response, leading to sustained weight reduction for at least a year. In addition to targeting Axokine to early responders, Regeneron could further limit Axokine to those recipients that do not develop anti-Axokine antibodies if methods of profiling these patients can be developed. The way in which Regeneron approaches these refinements remains to be seen, although Regeneron’s stated plan is to treat obese individuals with Regeneron “for 3 months, evaluating their weight loss, and then continuing treatment longer-term for those who are early responders…to improve the risk benefit profile of Axokine.”  Weight loss results at the end of 1 year for early responders to Axokine compared with those who were not early responders on an intent-to- treat basis are summarized below:    Early Responders (n=472) Non-early Responders (n=995) Fraction of total Axokine group 32.2% 67.8% Average weight loss  16.6 pounds (6.9%) 1.3 pounds (0.6%) Proportion who lost 5% of weight               54.9% 11.0% Proportion who lost 10% of weight 29.2% 2.8% These data are from a phase III randomized, double-blind, placebo-controlled investigation of 501 placebo-treated and 1,467 Axokine-treated participants with an average baseline weight for all participants of approximately 235 pounds. For 12 months, in combination with counseling in a dietary and lifestyle modification program, study subjects received daily subcutaneous injections of either placebo or Axokine 1.0 microgram per kilogram of body weight.
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