>>Neurogen Announces Results of First-in-Human Trial for New Approach to Treating Obesity
Wednesday May 2, 7:30 am ET
BRANFORD, Conn.--(BUSINESS WIRE)--Neurogen Corporation (Nasdaq: NRGN - News) today announced that it has completed a single ascending dose, first-in-human study with NGD-4715, the Company's leading drug candidate for the treatment of obesity. NGD-4715 works as a small molecule antagonist at the melanin concentrating hormone receptor-1 (MCHR1). The compound was safe and well tolerated at all doses studied in this clinical trial.
MCHR1 represents a new biological target for treating obesity and is the subject of research programs at many major pharmaceutical companies. Neurogen believes its MCHR1 program may be the most advanced in the industry. NGD-4715 and other compounds in the Company's MCHR1 obesity program are wholly-owned by Neurogen.
The recently completed Phase I clinical trial was a randomized, double-blind, placebo-controlled evaluation in healthy overweight and obese subjects of the safety, tolerability and pharmacokinetics of single rising oral doses of NGD-4715. The study enrolled 71 male and female subjects. NGD-4715 was studied across a broad range of doses in this trial and was safe and well tolerated at all doses. During the trial, blood levels of the compound exhibited a consistent dose dependent increase.
William H. Koster, President and CEO, said, "We are exploring an entirely new target for therapeutics to treat obesity and are extremely pleased that NGD-4715 is advancing in human clinical studies. Next, we will conduct a multiple ascending dose study in healthy volunteers and then plan to proceed into a Phase 2 proof-of-concept study in obese patients.
"While the MCHR1 mechanism has been an area of high interest in the pharmaceutical community, we believe most in the industry have encountered significant obstacles to advancing drug candidates into human studies. Neurogen has established a leading position with this promising new target and we hope to provide an effective therapeutic for the growing number of patients affected by obesity and its many co-morbidities, including diabetes and hypertension."
Neurogen's obesity program is focused on blocking the melanin concentrating hormone receptor-1 (MCHR1). When the neuropeptide MCH binds to the receptor, it stimulates food intake. Reported studies in rodents support MCH being an important mediator of caloric intake; deletion of MCH or the MCHR1 receptor gene resulted in lean animals, while over-production of MCH caused increased weight gain. Neurogen scientists presented data at the North American Association for the Study of Obesity (NAASO) in November 2004, which the Company believes was the first reported finding of the utility of an MCHR1 antagonist in a non-rodent species that, like humans, expresses both a MCH type 1 and MCH type 2 receptor. The Company's studies indicated that selectively blocking MCHR1 was sufficient to achieve a significant reduction in food intake in a higher animal species.<<
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Yeah, one wonders how long till the start of the multiple dose P1. That will presumably take longer than the 6 months for the single dose study. I'm not expecting announcement that the trial has started to move the stock, but rather results or continued thumbs up from DSMB. My guess is there's some time to get in on NRGN again.
All sorts of big & little pharma hunting this target, but not sure if anyone's in the clinic yet; Lilly, P&G, Glaxo, Abbott, Merck, Amgen (perhaps a vestige of a Tularik program, which had looked at MCHR2), Schering-Plough, Banyu, NBIX, MLNM, PCOP, maybe Astrta Zeneca and Servier (who did early research). Also being tested for anxiety and depression by Taisho and others. The IP must be a nightmare to figure. I'd love to hear more about the IP angle from NRGN.
Cheers, Tuck |
