The Phase I hurdle

Given that efficacy is the basis for drug approval, it is understandable that Phase II and Phase III clinical development get a great deal of attention. Nevertheless, companies sometimes get a reminder that Phase I safety and pharmacokinetic trials are still a hurdle that must be overcome. Neurogen Corp. and its pharma partners have knocked over their share of low hurdles, with three of its first four small molecule clinical programs hitting a snag in Phase I studies.

The company last week announced a minimum three-month delay in its obesity program with partner Pfizer Inc. (New York, N.Y.) after 25 percent of patients treated with a high dose of NRGN's NGD 95-1