This is old news by posted for the record.
NEUROGEN
neuroinvestment.com
From January 2001 overview
Perhaps the third time will be the charm for Neurogen and anxiety. Pfizer has taken the third selective GABA-A antagonist developed by Neurogen into Phase II. This will be a 280pt study, and its timeframe for completion will be considerably longer than we had previously estimated. With enrollment likely to take 15 months, and a six week dosing schedule, we doubt that data will come out until quite late in 2002. That data will compare two dose levels of NGD-95-3 to placebo and Xanax in the treatment of Generalized Anxiety Disorder. If successful, a Phase III would then follow. It thus remains two to three years behind Interneuron's pagoclone in the race for a new anxiolytic. The next most advanced program is NGD-97-1, which seeks to upregulate cognition in dementing disorders by serving as an inverse agonist for those GABA-A subtypes whose activation diminishes cognitive clarity and memory functions, as is seen with benzodiazepines. Phase I was successful, Phase II should begin during 1H:01. The insomnia program continues to be at an impasse, with the lead molecule (NGD-96-1) not suitable pharmacokinetically for commercialization. They continue to use it to explore potential adverse effect issues preclinically, but are still looking for a backup molecule with the kind of rapid onset and short half-life which is now de rigeur in insomnia treatment.
The most advanced preclinical program is in CRF antagonism, the same area being pursued by Neurocrine Biosciences and others. Neurogen believes that the chemical structure of their compounds differs from that of the group that proved toxic for Neurocrine and Janssen, though we do not know how similar or dissimilar it is to the new NBIX CRF antagonist group. Neurogen is still conducting preclinical toxicology studies while assessing their compound in animal models of depression. Their complement (C5A antagonist) program is also in animal studies. Whereas Alexion's C5A drug is a peptide, Neurogen's is a small molecule, which would give it some manufacturing and delivery advantages. Pfizer ended the collaboration studying neuropeptide Y modulation for obesity, Pfizer choosing to take some compounds in-house for further work. The future of that particular approach seems quite murky at present. Neurogen is continuing early-stage research on their melanin concentrating hormone program for obesity, and the VR-1 antagonist for pain.
When CEO Harry Penner announced he would be stepping down, it triggered quite a rally in Neurogen's stock price. Under his stewardship, Neurogen had maintained its reputation for strong science, a close but perhaps overly dependent alliance with Pfizer, and a solid balance sheet, but none of its compounds ever made it past Phase II. It will be interesting to see if the next CEO takes a more independent stance with the programs that remain inhouse. |
