BRANFORD, Conn., Feb. 5 -- Neurogen Corporation (Nasdaq: NRGN) today announced the commencement of Phase Ib human clinical studies of its anti-obesity drug, NGD 95-1, which it is co-developing with Pfizer Inc. The studies will examine the drug's safety and pharmacokinetic profile over 14 days of multiple dose administration to overweight, but otherwise healthy, male and female volunteers.
"Our studies to date have demonstrated that NGD 95-1 is safe when subjects receive a single dose of the drug. We are now eager to further establish its safety and pharmacologic profile in multiple doses over an extended period," said Harry H. Penner, Neurogen's President and CEO. "Pfizer has been very supportive of Neurogen's efforts in these Phase I trials, and we look forward to working with our partner to advance the drug into Phase II efficacy studies." Earlier double blind Phase I studies completed in July and December 1996 tested single escalating doses of NGD 95-1 in over 80 overweight, but otherwise normal, males and females.
These studies indicated that the drug was safe and well-tolerated across a wide dosing window. Neurogen is conducting Phase I clinical trials with NGD 95-1 under Pfizer auspices pursuant to a collaborative agreement concluded in November 1995. Phase II clinical studies conducted by Pfizer may commence as early as this summer. NGD 95-1 is an orally active small molecule antagonist of NPY receptors and is presumed to be the first NPY antagonist to be tested in humans.
NPY is strongly linked to appetite and is thought to be the most potent known stimulator of eating in animals. In a variety of animal studies Neurogen has demonstrated that NGD 95-1 blocks NPY-induced feeding, and in a three week study NGD 95-1 significantly reduced weight gain in normal rats.
CONTACT: Stephen R. Davis, or Amy C. Enders, both of Neurogen Corporation, 203-488-8201; or James W. Heins, media, or Reagan Codner, investors, both of Burns McClellan, Inc., 212-505-1919/