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): April 16, 2015
RECEPTOS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-35900
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26-4190792
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(State or other jurisdiction of
incorporation or organization) |
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(Commission
File Number |
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(I.R.S. Employer
Identification No.) |
3033 Science Park Road, Suite 300
San Diego, California 92121
(858) 652-5700
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
On April 16, 2015, Receptos, Inc. (Receptos or the Company) issued a press release announcing top-line results for the maintenance
period of its Phase 2 TOUCHSTONE trial of ozanimod (formerly RPC1063) in Ulcerative Colitis, as further described in Item 8.01 below. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated into this Item 7.01 by
reference.
The information in this Item 7.01 as well as Exhibit 99.1 to this report is being furnished to the Securities and Exchange Commission and
shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended (the Securities Act), or the Exchange Act, whether made before or after the date hereof.
Item 8.01. Other Events.
On April 16, 2015,
Receptos announced that the maintenance period of TOUCHSTONE, the Phase 2 trial of ozanimod (formerly RPC1063) in ulcerative colitis (UC), met all of its efficacy endpoints with statistical significance in patients on the 1 mg dose of ozanimod after
32 weeks of treatment. The overall safety and tolerability profile of ozanimod was consistent with the results of TOUCHSTONEs induction period and those observed in the Companys RADIANCE Phase 2 trial in relapsing multiple sclerosis
(RMS), and continues in the Companys belief to support the potential for orally administered ozanimod to significantly improve the treatment paradigm for UC patients.
The randomized, double-blind, placebo-controlled trial assessed the efficacy, safety and tolerability of two orally administered doses (0.5 mg and 1 mg) of
ozanimod versus placebo in 199 patients with moderately-to-severely active UC across 57 sites in 13 countries. For the induction period, the trial met its primary efficacy and all secondary endpoints with statistical significance for patients on the
1 mg dose after 8 weeks of treatment. In the maintenance period of the trial, 103 patients who had achieved clinical response at week 8 continued with treatment for an additional 24 weeks. The proportion of patients in clinical remission at week 32
as defined by the industry standard Mayo scoring criteria was statistically significant in favor of both the 1 mg group and the 0.5 mg group (p < 0.05) compared to placebo. All secondary endpoints at week 32, including clinical response, change
in the Mayo score and mucosal improvement on endoscopy, were also positive and statistically significant for the 1 mg dose.
Ozanimod was generally well
tolerated, and the incidence of adverse events across the active treatment groups and placebo appeared to be similar. Most adverse events were either mild or moderate in nature, and there appeared to be no concerning signals in the adverse events of
special interest, including the cardiac and hepatic safety profiles. Rates of liver transaminase elevations observed in patients receiving ozanimod were low and consistent with the earlier Phase 2 trial in RMS.
Receptos intends to move forward with a Phase 3 trial of RPC1063 in UC and a Phase 2 program in Crohns disease in 2015.
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Receptos, Inc. on April 16, 2015. |
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Exhibit 99.1 to this report is being furnished to the Securities and Exchange Commission and shall not be deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that
section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, whether made before or after the date hereof. |
Forward-Looking Statements
The statement in this Current Report on Form 8-K, other than statements of historical fact, constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. The words intends, continues and belief, as well as similar expressions are intended to identify forward-looking statements. These forward-looking
statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the safety, efficacy and projected development timeline of RPC1063, constitute
forward-looking statements. These forward-looking statements are based upon the Companys current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation consistency of trial results to date with further trial results, the Companys ability to
adequately and timely recruit and enroll patients in its clinical trials, as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics.
These and other risks are described in detail in the Companys SEC filings, including the Companys Annual Report on Form 10-K for the year ended December 31, 2014. All forward-looking statements contained in this report speak only as
of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.
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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.
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Date: April 16, 2015 |
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RECEPTOS, INC. |
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By: |
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/s/ Christian Waage
Christian Waage Senior Vice President & General
Counsel |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Receptos, Inc. on April 16, 2015. |
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Exhibit 99.1 to this report is being furnished to the Securities and Exchange Commission and shall not be deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that
section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, whether made before or after the date hereof. |
Exhibit 99.1
Receptos Reports Positive Results for the Maintenance Period of the Phase 2 TOUCHSTONE Trial of Ozanimod in
Ulcerative Colitis
- Study
met all efficacy endpoints with statistical significance for patients on 1 mg dose after 32 weeks of treatment -
- Safety data are
consistent with the favorable profile observed in prior clinical trials -
- Receptos plans to accelerate initiation of Phase 3 program in
ulcerative colitis and Phase 2 program in Crohns disease -
SAN DIEGO, April 16, 2015 Receptos, Inc. (Nasdaq: RCPT) today announced that
the maintenance period of TOUCHSTONE, the Phase 2 trial of ozanimod (formerly RPC1063) in ulcerative colitis (UC), met all of its efficacy endpoints with statistical significance in patients on the 1 mg dose of ozanimod after 32 weeks of treatment.
The overall safety and tolerability profile of ozanimod was consistent with the results of TOUCHSTONEs induction period and those observed in the RADIANCE Phase 2 trial in relapsing multiple sclerosis (RMS), and continues to support the
potential for orally administered ozanimod to significantly improve the treatment paradigm for UC patients.
This randomized, double-blind,
placebo-controlled trial assessed the efficacy, safety and tolerability of two orally administered doses (0.5 mg and 1 mg) of ozanimod versus placebo in 199 patients with moderately-to-severely active UC across 57 sites in 13 countries. For the
induction period, the trial met its primary efficacy and all secondary endpoints with statistical significance for patients on the 1 mg dose after 8 weeks of treatment. In the maintenance period of the trial, 103 patients who had achieved clinical
response at week 8 continued with treatment for an additional 24 weeks. The proportion of patients in clinical remission at week 32 as defined by the industry standard Mayo scoring criteria was statistically significant in favor of both the 1 mg
group and the 0.5 mg group (p < 0.05) compared to placebo.
All secondary endpoints at week 32, including clinical response, change in the Mayo score
and mucosal improvement on endoscopy were also positive and statistically significant for the 1 mg dose. The detailed results of the maintenance period portion of the TOUCHSTONE trial are expected to be presented at a major scientific meeting in the
coming months.
Ozanimod was generally well tolerated, and the incidence of adverse events across the active treatment groups and placebo appeared to be
similar. Most adverse events were either mild or moderate in nature, and there appeared to be no concerning signals in the adverse events of special interest, including the cardiac and hepatic safety profiles. Rates of liver transaminase elevations
observed in patients receiving ozanimod were low and consistent with the earlier Phase 2 trial in RMS.
The maintenance results of this trial appear
to demonstrate robust longer term efficacy of ozanimod, said Dr. William Sandborn, M.D., Professor of Medicine and Chief, Division of Gastroenterology and Director, University of California San Diego Inflammatory Bowel Disease Center.
Ozanimod appears to be effective in both inducing and maintaining clinical remission and response in patients with ulcerative colitis, with a favorable overall safety profile.
Receptos plans to initiate a Phase 3 program in 2015 in patients with moderately-to-severely active UC. In addition, these results continue to suggest the
potential for ozanimod to be used in the treatment of Crohns disease, a related inflammatory bowel disease. Receptos plans to initiate a Phase 2 study of ozanimod for the treatment of Crohns disease in 2015.
The positive results of the maintenance period of the TOUCHSTONE study exceeded our expectations with respect to the longer term effects of
ozanimod, said Faheem Hasnain, President and Chief Executive Officer of Receptos. The consistency of the efficacy data across the various endpoints for the high dose, combined with the favorable safety profile, gives us continued
confidence to advance the development of ozanimod in inflammatory bowel disease. Having completed our end-of-phase 2 meeting with the FDA and Scientific Advice meetings with the Competent Authorities in Europe, we believe that we now have regulatory
alignment and are prepared to accelerate the initiation the Phase 3 program in ulcerative colitis.
About Receptos
Receptos is a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases. The Companys lead
program, ozanimod, is a sphingosine 1-phosphate 1 and 5 receptor small molecule modulator in development for immune indications including RMS and IBD. Patents supporting ozanimod were exclusively licensed to Receptos from The Scripps
Research Institute (TSRI). The Company is also developing RPC4046, an anti-interleukin-13 (IL- 13) antibody for eosinophilic esophagitis (EoE), an allergic/immune-mediated orphan disease.
About Ozanimod
Ozanimod (formerly RPC1063) is a novel, oral, once daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator in development for autoimmune
indications including relapsing multiple sclerosis (RMS) and ulcerative colitis (UC). In a Phase 2 trial in patients with RMS, ozanimod achieved the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring
effects on other MRI parameters. The overall safety profile of ozanimod was consistent with the results of prior trials and continues to demonstrate differentiation against other oral agents for treatment of RMS. Receptos is now conducting a Phase 3
clinical development program comprised of two trials: RADIANCE and SUNBEAM, both of which are randomized, double-blind studies designed to compare 0.5 mg and 1.0 mg of ozanimod against interferon beta-1a (Avonex®) in patients with RMS.
Ozanimod is also being studied in inflammatory bowel disease (IBD). The
TOUCHSTONE Phase 2 trial of ozanimod in UC met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1.0 mg dose of ozanimod in the 8-week induction period. The overall safety and tolerability profile of
ozanimod was consistent with the results of the recent Phase 2 trial in RMS, and continues to support the potential for orally administered ozanimod to significantly improve the treatment paradigm for UC patients. Receptos plans to initiate a Phase
3 program in UC and a Phase 2 program in Crohns disease in 2015.
Forward-Looking Statements
Statements contained in this release, other than statements of historical fact, constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. The words expects, believes, anticipates, may, intends, plans, potential and similar expressions are intended to
identify forward-looking statements. Investors are cautioned that these forward-looking statements are not guarantees of future performance. Forward-looking statements, include without limitation, the ability of the Company to successfully undertake
certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals (such as the completion of clinical trials and availability of clinical trial results), and the safety,
efficacy, projected development timeline and therapeutic and commercial potential for ozanimod. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those
anticipated. These forward-looking statements are based upon the Companys current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks associated with the process of discovering, developing and commercializing drug candidates
that are safe and effective for use as human therapeutics. These and other risks regarding the Companys financial position and research and development programs are described in detail in the Companys SEC filings,
including the Companys Annual Report on Form 10-K for the year ended December 31, 2014. All forward-looking statements contained in this release speak only as of the date on which they were first made by the Company, and the Company
undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.
Media and Investor
Contacts:
Graham K. Cooper
Chief Financial Officer,
Receptos
(858) 652-5708
gcooper@receptos.com
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