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): August 24, 2016
Inotek Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
| DELAWARE | 001-36829 | 04-3475813 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 91 Hartwell Avenue Lexington, MA |
02421 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code (781) 676-2100
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:
| ¨ | 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 August 24, 2016, Inotek Pharmaceuticals Corporation (the “Company”) issued a press release announcing the completion of the active recruitment phase of its MATrX-1 trial, the first pivotal Phase 3 trial of trabodenoson for the treatment of glaucoma. A copy of the press release is filed as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated August 24, 2016 | |
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.
| Date: August 24, 2016 | INOTEK PHARMACEUTICALS CORPORATION | |||||
| By: | /s/ Dale Ritter | |||||
| Dale Ritter | ||||||
| Vice President —Finance | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated August 24, 2016 | |
Exhibit 99.1
Inotek Pharmaceuticals Announces the Completion of the Recruitment Phase of MATrX-1, the
First Phase 3 Clinical Trial of Trabodenoson for Glaucoma
- Top-line Data Expected in December 2016 -
LEXINGTON, Mass – August 24, 2016 – Inotek Pharmaceuticals Corporation (NASDAQ: ITEK), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for ocular diseases, today announced the completion of the active recruitment phase of MATrX-1, the first pivotal Phase 3 trial of trabodenoson for the treatment of glaucoma. Trabodenoson, the Company’s lead clinical candidate, is a first-in-class selective adenosine A1 mimetic under investigation for reduction of intraocular pressure (IOP) which has been observed in Phase 2 clinical trials to reduce IOP. Top-line data from the MATrX-1 study are expected in December 2016.
“As anticipated, MATrX-1 has recruited on time, consistent with our fourth-quarter guidance for top-line data,” said Rudolf Baumgartner, MD, Executive Vice President and Chief Medical Officer. “Trabodenoson has the potential to be a convenient, safe and innovative treatment option for patients suffering from glaucoma based on its targeted approach of restoring the natural pressure-regulating process in the eye to lower IOP, and we are looking forward to the results of this trial.”
About the MATrX-1 Phase 3 Trial
MATrX-1 is a Phase 3 randomized, double-masked, placebo-controlled trial of trabodenoson in (~)335 patients suffering from primary open angle glaucoma (POAG) or ocular hypertension (OHT) that is designed to assess the efficacy, safety and tolerability of trabodenoson over three months of treatment. The primary endpoint is reduction of IOP as compared to the placebo treatment arm. The study includes three doses of trabodenoson: 3% (1000 mcg) once daily, 4.5% (1500 mcg) twice daily, and 6% (2000 mcg) once daily. In addition, the study contains a timolol 0.5% arm to validate the sensitivity of the patient population and will serve as an internal control. Enrollment criteria include patients with IOP greater than or equal to 24 mm Hg and less than or equal to 34 mm Hg, which represents the patients most likely to receive treatment for glaucoma or ocular hypertension.
About Inotek Pharmaceuticals Corporation
Inotek Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases. The Company’s lead product candidate, trabodenoson, is a first-in-class selective adenosine mimetic currently in Phase 3 development. Trabodenoson was developed in Inotek’s laboratories and is designed to restore the eye’s natural pressure control mechanism. Additionally, the Company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases. For more information, please visit www.inotekpharma.com. The inclusion of our website address here and elsewhere in this press release does not include or incorporate by reference the information on our website into this press release.
Forward-Looking Statements
This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. These forward-looking statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Inotek Contact:
Claudine Prowse, Ph.D., 781-552-4305
Vice President, Strategy, Business Development, and IRO
IR@inotekpharma.com
Investor Contact:
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com
Media Contact:
MacDougall Biomedical Communications
Karen Sharma, 781-235-3060
ksharma@macbiocom.com