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April 01, 2003, Preliminary data from Regeneron’s (NASDAQ: REGN) initial phase III clinical trial suggest that the magnitude of Axokine’s anti-obesity effects are clinically significant in the short-term, but most likely inadequate for long-term care. The achievement of soft primary endpoints is overshadowed by the observation that the duration of anti-obesity effects for a significant proportion of recipients is likely to be even shorter than for marketed anti-obesity compounds, already plagued by poorly sustained effectiveness. Axokine’s limited duration of therapeutic effect is associated with the development of anti-Axokine antibodies, as approximately 60% of Axokine recipients developed anti-Axokine antibodies. The results considerably diminish Axokine’s likelihood of FDA approval for unrestricted use in the general population. If approved, these results will limit sales potential.
The phase III investigation was a randomized, double blind, placebo-controlled trial of 501 placebo-treated and 1,467 Axokine-treated non-diabetic, obese study subjects. Participants received daily subcutaneous injections of either placebo or Axokine 1.0 microgram per kilogram. Statistically, Axokine advantages (one-year study) in the intent-to-treat analysis included:
proportion of recipients losing at least 5% of their initial body weight – 25.1% to 17.6% (a primary endpoint)
average weight loss – 6.2 lbs versus 2.6 lbs (a primary endpoint)
proportion of recipients losing at least 10% of their initial body weight – 11.3% vs. 4.2%.
For the approximately 30% of Axokine recipients that did not develop antibodies by the end of one year, sustained therapeutic effects were observed. These results accounted for the lion’s share of the therapeutic success of the overall program. The inability to prospectively identify these individuals diminishes the probability that Axokine will enjoy widespread success for the general population. These anti-Axokine antibody-free recipients experienced the following statistically significant advantages over placebo recipients in the intent-to-treat analysis:
average weight loss – 12.6 lbs versus 4.5 lbs proportion of patients losing at least 5% of initial body weight – 46% versus 24%
proportion of patients losing at least 10% of initial body weight – 24% versus 6.6%.
Axokine’s one-year safety, tolerability, and adverse effect profiles were reassuring. An analysis of data generated by only those study subjects completing the full follow-up period demonstrates an expected exaggeration of therapeutic effects. A significant proportion of these results were due to the inability of subjects who developed anti-Axokine antibody to complete the study protocol.
This investigational phase of the trial is being followed by a 12-month open-label safety extension phase. Regeneron plans to complete the analysis of a pilot study in obese subjects with type II diabetes, and to complete ongoing short-term treatment investigations before deciding how to proceed with Axokine development.
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