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
Date of Report (Date of Earliest Event Reported): December 17, 2012
TRANZYME, INC.
(Exact name of registrant as specified in its charter)
DELAWARE |
|
001-35119 |
|
63-1192270 |
(State or other jurisdiction |
|
(Commission File Number) |
|
(I.R.S. Employer |
of |
|
|
|
Identification No.) |
incorporation) |
|
|
|
|
5001 South Miami Boulevard, Suite 300 |
|
|
Durham, NC |
|
27703 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrants telephone number, including area code (919) 474-0020
Not Applicable
(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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 December 17, 2012, Tranzyme, Inc. issued a press release announcing that it will be stopping its second of two Phase 2b clinical trials evaluating the efficacy and safety of its oral ghrelin agonist TZP-102 in diabetic patients with gastroparesis, which trial is known as DIGEST, in light of its analysis of the interim results.
The full text of the press release regarding the announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
Press release of Tranzyme, Inc. dated December 17, 2012. |
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.
December 17, 2012 |
Tranzyme, Inc. | |
|
|
|
|
By: |
/s/Vipin K. Garg, Ph.D. |
|
Name: Vipin K. Garg, Ph.D. | |
|
Title: President and Chief Executive Officer |
Exhibit 99.1
PRESS RELEASE
Tranzyme Pharmas DIGEST Trial Stopped for Futility After Interim Analysis of the Phase 2b Results
RESEARCH TRIANGLE PARK, NC (December 17, 2012) Tranzyme Pharma (NASDAQ: TZYM), today announced it is discontinuing and immediately ending patient enrollment in DIGEST, a Phase 2b trial in diabetic patients receiving TZP-102 for the management of symptoms of gastroparesis, due to insufficient efficacy. The decision followed a planned interim futility analysis, which examined patients responsiveness to thrice daily oral dosing of 10mg of TZP-102 or placebo at the end of weeks 4 and 8 of a 12 week trial. The results are consistent with the findings of a prior Phase 2b trial in that there was a very large placebo effect and no treatment effect.
About Tranzyme Pharma
Tranzyme Pharma is a biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics for the treatment of upper gastrointestinal (GI) motility disorders. While approximately 40 percent of people in the U.S. are affected by these persistent and recurring conditions which disrupt the normal movement of food throughout the GI tract, there are a limited number of safe and effective treatment options. By leveraging its proprietary drug discovery technology, MATCH, Tranzyme is committed to pursuing first-in-class medicines to address areas of significant unmet medical needs.
Further information about Tranzyme Pharma can be found on the Companys web site at www.tranzyme.com.
Corporate Inquiries:
Susan Sharpe
Director, Corporate Communications
(919) 328-1109
ssharpe@tranzyme.com
Investor Inquiries:
David Carey
Lazar Partners, Ltd.
(212) 867-1768
dcarey@lazarpartners.com