Biotech Tracker News - Axokine for Type II Diabetics
April 15, 2003, In spite of many companies pursuing anti-obesity programs, drug therapy continues to have severe limitations in the management of obesity. This month, confirmatory data highlighted the limitations of several marketed agents (see April 8 BT News). Also this month, Regeneron’s (NASDAQ: REGN) Axokine generated disappointing phase III data (see April 1 BT News).  While appropriate diet and exercise will continue to be the best weight reduction option for most overweight people for the foreseeable future, Axokine (recombinant ciliary neurotrophic factor) continues to merit continued development, especially in certain subpopulations. The most prevalent of these is type II diabetics. Yesterday, Regeneron announced preliminary phase II data that address the potential of Axokine in this population. In spite of one statistically significant outcome and multiple outcomes associated with a trend towards benefit, Axokine’s magnitude of therapeutic effect in type II diabetics remains suspect.  Axokine 0.5 and 1.0 micrograms per kilogram per day was evaluated in overweight and obese people with type II diabetes. The randomized, double-blind, placebo-controlled clinical trial enrolled 157 study subjects who weighed, on average, approximately 233 lbs. After a 14-day run-in period, participants were randomly assigned to receive daily subcutaneous injections of either Axokine dose level or placebo for 12 weeks. 12 weeks of high-dose administration was associated with statistically significant, dose-dependent weight loss.  In the most rigorous (intention to treat) analysis, high-dose Axokine plus dietary counseling was superior to placebo plus dietary counseling in terms of average weight loss (6.5 pounds versus 2.5 pounds), improvements in blood glucose, and certain other metabolic parameters. Only the average weight loss outcome achieved statistical significance. 18.9% of high-dose Axokine recipients and 5.8% of placebo recipients achieved a weight loss of at least 5% body weight. Approximately one-third of the high-dose Axokine recipients developed likely response-limiting anti-Axokine antibodies. These antibodies were definitively associated with poor clinical outcomes in the phase III trial, and appear to similarly affect outcomes in this trial. Axokine’s tolerability and serious adverse event profiles were reassuring. High-dose Axokine is being further evaluated in both an ongoing open-label extension phase and an ongoing, ambitious, phase III program.
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