8-K 1 f8k051106.htm POSITIVE PHASE II CLINICAL TRIAL RESULTS FOR INSOMNIA DRUG Positive Phase II Clinical Trial Results for Insomnia Drug
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 
May 11, 2006
Date of Report (Date of earliest event reported)
 
 
NEUROGEN CORPORATION
(Exact name of registrant as specified in its charter)
 
 
Delaware
(State or other jurisdiction of
incorporation)
 
 
0-18311
(Commission File Number)
 
 
22-2845714
(I.R.S. Employer Identification No.)
 
 
 
35 Northeast Industrial Road
Branford, Connecticut   06405
(Address of principal executive offices) (Zip Code)
 
(203) 488-8201
(Registrant's telephone number, including area code)
 
None
(Former name or former address, if changed since last report)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:  
 
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))  
 
 
 
 
Item 8.01 Other Events
 
On May 11, 2006, Neurogen Corporation issued a press release announcing top-line results of Phase II human testing in transient insomnia for the Company’s internally discovered drug candidate for insomnia, NG2-73. The primary endpoint of the study measured the efficacy of NG2-73 in reducing time to onset of persistent sleep in a well established clinical model of transient insomnia in healthy adults. In this multi-center, 369 subject study, NG2-73 was shown to significantly reduce time to onset of persistent sleep versus placebo at all doses tested.
 
Study Results
In top-line results, NG2-73 demonstrated statistically significant improvement over placebo (overall p<0.0001) for reducing Latency to Persistent Sleep (LPS) at all doses tested.

The following table shows mean LPS in minutes:
 

 
placebo
(n=74)
1mg
(n = 73)
3mg
(n=69)
10mg
(n=72)
20mg
(n=71)
           
     ·  
LPS
30.8
17.8
10.6
7.8
6.6
       ·   
p value
 
<0.01
<0.001
<0.001
<0.001
·  
percent improvement relative to placebo
 
42%
65%
75%
79%

 In this study NG2-73 was well-tolerated at all doses, with no drug-related serious adverse events or drug-related premature subject withdrawals.

Study Design
The Phase II clinical trial was a randomized, double-blind, placebo-controlled study, designed to determine the efficacy of four dose levels (1, 3, 10 and 20 mg) of NG2-73 compared to placebo in reducing the time it takes to fall asleep as defined by LPS. Dose selection was made on the basis of a prior Phase I pharmacokinetic/pharmacodynamic (PK/PD) trial which studied a range of doses of NG2-73 against placebo and an active comparator.

In this Phase II study, LPS was measured in a single-night, validated model of transient insomnia. The exposure response relationship for NG2-73 is being examined using PK/PD modeling. The study was conducted at 11 sites in the United States. Healthy adult subjects were enrolled in five treatment arms totaling 369 subjects.

NG2-73 is a partial agonist, preferential for the alpha-3 receptor subtype of the gamma-aminobutyric acid (GABAA) neurotransmitter system. NG2-73 and related compounds are a part of Neurogen’s wholly-owned insomnia program. During 2005, Neurogen announced results from a first-in-human, single ascending dose study and a multiple ascending dose study for NG2-73. In both of these Phase I trials, the compound was safe and well-tolerated with no serious adverse events.
 
 
 
 
 SAFE HARBOR STATEMENT
 
Statements which are not historical facts, including statements about the Company's confidence and strategies, the status of various product development programs, the sufficiency of cash to fund planned operations and the Company's expectations concerning its development compounds, drug discovery technologies and opportunities in the pharmaceutical marketplace are "forward looking statements" within the meaning of the Private Securities Litigations Reform Act of 1995 that involve risks and uncertainties and are not guarantees of future performance. These risks include, but are not limited to, difficulties or delays in development, testing, regulatory approval, production and marketing of any of the Company's drug candidates, the failure to attract or retain scientific management personnel, any unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates which could slow or prevent product development efforts, competition within the Company's anticipated product markets, the Company's dependence on corporate partners with respect to research and development funding, regulatory filings and manufacturing and marketing expertise, the inherent uncertainty of product development in the pharmaceutical industry, difficulties or delays in development, testing, regulatory approval, production and marketing of any of the Company's drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of the Company's drug candidates or other properties of drug candidates which could make them unattractive for commercialization, inability to obtain sufficient funds through future collaborative arrangements, equity or debt financings or other sources to continue the operation of the Company's business, risk that patents and confidentiality agreements will not adequately protect the Company's intellectual property or trade secrets, dependence upon third parties for the manufacture of potential products, inexperience in manufacturing and lack of internal manufacturing capabilities, dependence on third parties to market potential products, lack of sales and marketing capabilities, potential unavailability or inadequacy of medical insurance or other third-party reimbursement for the cost of purchases of the Company's products, and other risks detailed in the Company's Securities and Exchange Commission filings, including its Annual Report on Form 10-K for the year ended December 31, 2005, each of which could adversely affect the Company's business and the accuracy of the forward-looking statements contained herein. Future results may also differ from previously reported results. For example, positive results or safety and tolerability in one clinical study provide no assurance that this will be true in future studies.
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
NEUROGEN CORPORATION
 
(Registrant)
 
 
 
By: /s/ STEPHEN R. DAVIS
 
Name: Stephen R. Davis
Date: May 11, 2006
Title: Executive Vice President and Chief Operating Officer