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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (769)	7/17/2001 12:32:11 PM
From: keokalani'nui	Read Replies (4) \| Respond to of 1834

Notes from CC. Not double-checked and it got a little fuzzy toward the end. Rarely do you hear a company answer all the clinical questions directly, honestly, to the best of their ability. High quality all the way around. ____________ Primary (LTPS) and 2nd endpoints (total sleep, sleep efficiency and wakening after sleep onset) all met. No next day residual effects, and se profile same as placebo. This was the first time in this target population. 59 pts, with 6 way crossover (meaning every patient received all treatments in randomized fashion.) Highly SS efficacy at all doses, including lowest. Linear, progressive dose response. Lowest dose P=.016, and as dose went up p< .001. The p in the press release was the weakest. Increased total sleep was SS throughout with p improving with dose. As this is the immediate release dose, company is now especially optimistic for modified release in TS scores. No next day residual effects even at highest dose, comparable to placebo. Did not even appear to be a dose response. Totally consistent with 850 patients dosed to date (2000 patients if you count all the cross-over encounters). P3 to start 10/01. One year open label safety study because its for a chronic indication, in at least 100 patients and will be one dose. 2 other pivotal trails to start with 35-day consecutive with 2 doses. Doses were not disclosed, but are probably now known. Transient insomnia trial is completed, data in August. 330 patients. Elderly ongoing, results YE. From the investigator, Dr. ___: Most other sleep meds have flat response curves, this is linear and very unique and promising. Lack of residual next day se’s means middle-of-night-studies have good chance to succeed. Answers to Questions: If accepted on time, results published at Neurology or a YE sleep meeting. All secondary endpoints were SS and all showed dose response and p goes down with increase in dose. LTPS requires 10 consecutive minutes sleep. TST is measured in 8 hr period. Sleep Efficiency is TSTdivided by Time in Bed. Time to wake after sleep onset is what it sounds like. No dose effect on next day residual. Study was 2 consecutive nights on, then 5 or 12 day washout and back on. Will be looking for a middle of the night label, this will require more studies. Hope that success in MON will distinguish from Zoplicone. Standard formulation NDA expect to file middle 2003, modified release 5 months behind. Drug t1/2 is 1- 1.5 hrs, and formulation doesn’t change it. Believed a great benefit over Zolpride and Zoplicone whose ½ lives are much longer per published studies. LTSO for placebo was 36 minutes, on drug it was 19 min at highest dose and high 20s lowest dose. The 16-17 minute reduction is a 46% improvement. The transient insomnia trial (the follow/repeat of the 1999 P2) will be completed 8/01. 330 pts, and will be the largest sample using the commercial preparation. Young adult and elderly all need dose response data. Will be seeking labels for chronic efficacy and MON admin. Sounded like MON will involve head to head studies. Believe sepr drug has long ½ life and will have problems. Though management deflected more conversation on this. Liver tox studies not back yet, but previous 800 patients (some at higher doses than this trial given 14 consecutive days) and the primate (9 mos) and rodent (6 mos) studies at enormously higher equivalent doses all show no problems. ‘Exceedingly safe.’ This trail did not show how good the drug could be head to head against Ambien, because the protocol was single dose at bedtime. But the results support distinguishing improvements of multi-dose and MON dose vs Ambien. Ambien was a control to calibrate the system. Only competitive drugs mentioned by co were TAK’s melanacortin analogue and Zoplicone. Patient self assessment questionnaire results not in yet _______________________ Wilder