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): February 1, 2016
Carbylan Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36830 | 20-0915291 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
3181 Porter Drive
Palo Alto, California 94304
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (650) 855-6777
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 February 1, 2016, Carbylan Therapeutics, Inc. (the “Company”) issued a press release announcing top-line results from the Company’s COR 1.1 Phase 3 clinical trial of Hydros-TA for the treatment of pain associated with osteoarthritis of the knee (the “Press Release”). A copy of the Press Release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press release, “Carbylan Therapeutics Reports Top-Line Results from COR1.1 Clinical Trial of Hydros-TA in Patients with OA of the Knee,” dated February 1, 2016. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: February 1, 2016 | CARBYLAN THERAPEUTICS, INC. | |||||||
| By: | /s/ David M. Renzi | |||||||
| David M. Renzi President and Chief Executive Officer | ||||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press release, “Carbylan Therapeutics Reports Top-Line Results from COR1.1 Clinical Trial of Hydros-TA in Patients with OA of the Knee,” dated February 1, 2016. | |
Exhibit 99.1
Carbylan Therapeutics Reports Top-Line Results from COR1.1 Clinical Trial of
Hydros-TA in Patients with OA of the Knee
Palo Alto, Calif., February 1, 2016 - Carbylan Therapeutics (NASDAQ: CBYL), a specialty pharmaceutical company focused on the development of novel and proprietary combination therapies, today announced top-line results from COR1.1, its first Phase III trial of Hydros-TA for the treatment of pain associated with osteoarthritis of the knee. Hydros-TA is the company’s proprietary formulation of hyaluronic acid which entraps a low-dose corticosteroid, triamcinolone acetonide (TA). Hydros contains the same proprietary hyaluronic acid without the addition of TA.
COR1.1 was a 560 patient, international, multi-center, randomized, double-blind study designed to evaluate the safety and efficacy of Hydros-TA. The primary endpoints of the trial were changes from baseline in the WOMAC A pain scores at week 2 for Hydros-TA versus Hydros and at week 26 for Hydros-TA versus TA, or triamcinolone acetonide (10 mg), as well as a safety assessment of adverse events.
In the COR1.1 study, Hydros-TA met the first of its two primary endpoints, demonstrating a statistically significant improvement from baseline in the WOMAC A pain score at week 2 versus Hydros (hyaluronic acid alone). In addition, Hydros-TA maintained a significant reduction in pain from baseline over 26 weeks. However, patients in the TA arm continued to show an unexpected significant reduction in pain through 26 weeks. Given the comparable effectiveness at 26 weeks, COR1.1 did not meet its second primary endpoint. Hydros-TA was generally well tolerated with no treatment related serious adverse events (SAEs), and adverse events (AEs) were mostly mild and included arthralgia (knee pain) and swelling.
“We are pleased to have achieved one of our primary endpoints in our COR1.1 trial. This demonstrates that Hydros-TA can provide early onset of pain relief with a low-dose corticosteroid,” stated David Renzi, President and CEO of Carbylan Therapeutics, “However, patients who received the corticosteroid triamcinolone acetonide, or TA, showed a prolonged pain-reduction through 26 weeks, which was unexpected based on clinical experience and published literature. We are very pleased that Hydros-TA and Hydros performed as expected throughout the course of the study, and we are actively reviewing the trial data in order to better understand the reported duration of effect of TA at 26 weeks. We look forward to sharing with our investors our future plans for the continued development of Hydros-TA.”
Conference Call and Webcast,
Carbylan Therapeutics will host a conference call at 4:30 p.m. ET today to discuss the clinical trial results. The conference call can be accessed by dialing 877-407-9039 for domestic callers, and 201-689-8470 for international callers. The conference ID number is 13629929. In addition to the call, a live webcast of the event will be available on the investor relations page of the Company’s website at www.carbylan.com.
Following the call, the event will remain archived on the Carbylan website for one year. In addition to the archive, a recording of the call will be available until February 8, 2016. The recording can be accessed by dialing 877-870-5176 for domestic callers, and 858-384-5517 for international callers. The conference ID number for the recording is 13629929.
About Carbylan Therapeutics
Carbylan is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel and proprietary combination therapies that address significant unmet clinical needs. The Company’s lead product candidate, Hydros-TA, is a proprietary, cross-linked combination of low dose corticosteroid and novel hyaluronic acid viscosupplement, designed to provide both rapid and sustained osteoarthritis pain relief via a single intra-articular injection.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Carbylan Therapeutics, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including statements regarding Carbylan’s ability to successfully complete, clinical and regulatory prerequisites and to bring Hydros-TA to market. Such forward-looking statements involve substantial risks and uncertainties that could cause Carbylan’s future results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing and success of regulatory filings and other matters that could affect the availability or commercial potential of Carbylan’s drug candidates. Carbylan Therapeutics undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Carbylan’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2015, and its subsequent periodic reports to be filed with the Securities and Exchange Commission.
Contacts
The Ruth Group
David Burke/Lee Roth
646-536-7009/7012
dburke@theruthgroup.com/lroth@theruthgroup.com