Neurogen halts obesity testing, hopes to outlicense MCH prpogram, but . . . Target looks suspect (how to know up front? Hard to test mice for awakenings & dream vividness), and dose modification messed up the efficacy. Not good.
>>Neurogen Announces Results of Multiple Ascending Dose Studies with Experimental Obesity Drug
Monday January 7, 8:00 pm ET
BRANFORD, Conn.--(BUSINESS WIRE)--Neurogen Corporation (Nasdaq: NRGN - News) today announced that it has completed the follow-up component of a Phase 1 multiple ascending dose (MAD) study with NGD-4715, an MCH-1 receptor antagonist being investigated for the treatment of obesity.
The initial phase of the MAD study utilized three times per day dosing (tid) for 14 days in healthy obese subjects exposed to a high caloric diet. As previously reported, during this phase moderate induction of the liver enzyme CYP 3A4 occurred, increasing the probability of accelerating metabolism of other drugs administered concomitantly. In addition, during the initial phase of the MAD study, lipid lowering effects were observed.
The follow-up study reported today was designed to test the effect of twice per day dosing (bid) in healthy obese subjects on a restricted caloric diet for 14 days. Using bid dosing, CYP3A4 induction was substantially reduced as measured by treatment with midazolam, a drug sensitive to changes in CYP 3A4 levels. With less frequent dosing and caloric restriction in the current trial, no effect on lipids was observed. As in the initial Phase 1 studies, no serious adverse events were observed. However, vivid dreams and awakenings were reported by half the drug treated subjects during the first week of dosing. These results suggest that the effect of MCH-1 receptor antagonism on caloric regulation and sleep architecture requires further study in humans. Based on the results of the MAD studies, Neurogen has determined that it will not advance the compound into Phase 2 testing at this time, but will consider out-licensing its MCH program for potential development with a partner.<<
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Announced so late that there is no after hours read, but I'd expect to see the stock back in the 2s, though deeper this time. Jeez, such a long haul for NRGN with little to show for it. And just in past year, big programs and promise result in . . . the VR1 program going into super slo-mo from clear leader to back in the pack with competitors, the insomnia drug showing itself to be an also ran in a crowded field, and now this. I've been out for a while, having traded NRGN successfully for modest gains. Hope everyone else here did OK.
Cheers, Tuck |
