Current Report Filing (8-k)

 

 

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): September 13, 2014

 

 

RECEPTOS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-35900		26-4190792
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(I.R.S. Employer Identification No.)

10835 Road to the Cure, Suite 205

San Diego, California 92121

[phone]

(Address, including zip code, and telephone number, including

area code, of registrant’s 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:

 

¨	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))

 

 

 

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Item 7.01.

Regulation FD Disclosure.

On September 13, 2014, Receptos, Inc. (the “Company”) reviewed in further detail the data from the Phase 2 portion of RADIANCE, the Company’s Phase 2/3 study of RPC1063 in Relapsing Multiple Sclerosis (RMS) in a presentation at MS Boston, using slides containing the information furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The Company does not undertake to update this presentation.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Slide presentation of Receptos, Inc. dated September 13, 2014.

The information in this Current Report on Form 8-K, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission pursuant to Item 7.01 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

 

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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.

 

Date: September 15, 2014				RECEPTOS, INC.
				By:		/s/ Christian Waage
						Christian Waage
						SVP & General Counsel

 

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EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Slide presentation of Receptos, Inc. dated September 13, 2014.

Phase 2 Results of the RADIANCE Trial: A Randomized, Double-Blind, Placebo-Controlled Trial of Oral RPC1063 in Relapsing Multiple Sclerosis Amit Bar-Or, MD September 13, 2014 1 Cleveland Clinic, Mellen Center for MS Treatment and Research, Cleveland, OH, United States 2 NeuroRx Research, Montreal, QC, Canada 3 McGill University, Montreal, QC, Canada 4 San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Neurology, Milan, Italy 5 Montreal Neurological Institute, Department of Neurology and Neurosurgery, Montreal, QC, Canada 6 Receptos, Inc., Clinical Development, San Diego, CA, United States 7 Medical University of Lodz, Department of Neurology, Lodz, Poland J Cohen 1 , DL Arnold 2,3 , G Comi 4 , A Bar-Or 5 , S Gujrathi 6 , JP Hartung 6 , A Olson 6 ,   M Cravets 6 , PA Frohna 6 , K Selmaj 7 Exhibit 99.1 2014 Joint ACTRIMS-ECTRIMS Meeting Boston, Massachusetts

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13 September 2014 2 ACTRIMS-ECTRIMS 2014 Conflict of Interest Statements Amit Bar-Or : financial support from Biogen Idec, DioGenix, Genentech, GlaxoSmithKline, Guthy-Jackson Charitable Foundation, Medimmune, Merck Serono, Novartis, Ono Pharmaceuticals, Receptos, Roche, Sanofi- Aventis, and Teva Neuroscience J Cohen : financial support from EMD Serono, Receptos, Genzyme/Sanofi, Innate Immunotherapeutics, Novartis DL Arnold : financial support from Receptos G Comi : financial support from Receptos K Selmaj : financial support from Biogen Idec, Novartis, Genzyme, Synthon, Roche, Merck, Receptos, Teva S Gujrathi, JP Hartung, A Olson, M Cravets & PA Frohna are full-time employees of Receptos

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13 September 2014 3 ACTRIMS-ECTRIMS 2014 Introduction Immunomodulation through the sphingosine 1-phosphate (S1P) receptor family is a validated therapeutic approach for the treatment of relapsing multiple sclerosis (RMS) RPC1063 is a novel, oral S1P 1,5R modulator in clinical development for RMS by Receptos, Inc., which has only been previously tested as single and multiple doses in healthy volunteer subjects The Phase 2 results presented today are from the RADIANCE trial: an ongoing international, combined Phase 2/3 trial of RPC1063 in adult patients with RMS

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13 September 2014 4 ACTRIMS-ECTRIMS 2014 RADIANCE Patient Population: Key Inclusion Criteria MS, as diagnosed by the revised McDonald criteria (2010) Exhibiting a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS Ages 18-55 years, inclusive EDSS at Baseline between 0 and 5.0 points, inclusive Meet 1 of the following RMS disease activity criteria: At least 1 documented relapse within the last 12 months OR At least 1 documented relapse within last 24 months plus at least 1 GdE lesion

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13 September 2014 5 ACTRIMS-ECTRIMS 2014 RADIANCE Phase 2 Trial Design 24-Week Placebo-Controlled Treatment  Period 30-day Screening Period 7-day Titration Period Randomization 1 mg RPC1063 0.5 mg RPC1063 Placebo Week -4 0 1 4 8 12 16 20 24 Safety Only Baseline Blinded Safety- Extension 1 mg RPC1063 0.5 mg RPC1063 1 mg RPC1063 0.5 mg RPC1063 Yearly 2° Efficacy Endpoints: 1. Number of GdE lesions at Week 24 2. Cumulative new or enlarging T2 lesions 3. Annualized Relapse Rate (ARR) MRI 1°Endpoint: GdE Lesions

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13 September 2014 6 ACTRIMS-ECTRIMS 2014 Patient Disposition Randomized (N=258) Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83) Discontinued 3 (3.4%) Adverse event 0 Lost to follow-up 1 (1.1%) Protocol violation 0 Consent withdrawn 2 (2.3%) Discontinued 2 (2.3%) Adverse event 0 Lost to follow-up 0 Protocol violation 1 (1.1%) Consent withdrawn 1 (1.1%) Discontinued 1 (1.2%) Adverse event 0 Lost to follow-up 0 Protocol violation 0 Consent withdrawn 1 (1.1%) Completed 85 (96.6%) Completed 85 (97.7%) Completed 82 (98.8%) Very high rate of study compliance and completion Similar completion rates across the treatment groups

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13 September 2014 7 ACTRIMS-ECTRIMS 2014 Patient Demographics and RMS Disease History Demographics Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83) Female – n (%) 62  (70.5) 60  (69.0) 59  (71.1) Age (yrs) 39.0 (8.7) 38.1 (9.2) 38.4 (9.8) RMS Disease History, mean (SD) Years since MS diagnosis 4.6 (5.1) 2.8 (5.0) 3.6 (4.4) EDSS Score at Baseline 2.85 (1.27) 2.94 (1.29) 2.86 (1.21) Relapses, last 12 months 1.3 (0.6) 1.5 (1.2) 1.3 (0.7) Relapses, last 24 months 1.8 (1.0) 2.0 (1.8) 1.9 (1.1) Gd-Enhancing lesions at Baseline 1.4 (3.4) 0.9 (1.4) 1.3 (2.8) Gd-Enhancing lesion free at Baseline, n (%) 62  (70.5) 53  (60.9) 52  (62.7)

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13 September 2014 8 ACTRIMS-ECTRIMS 2014 Primary Endpoint: Cumulative Number of Total GdE Lesions From Weeks 12 to 24 p < 0.0001 p < 0.0001 86% decrease 86% decrease 11.1 1.5 1.5 0 2 4 6 8 10 12 14 Treatment Group Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83)

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13 September 2014 9 ACTRIMS-ECTRIMS 2014 Secondary Endpoint (1): Mean Number of GdE Lesions at Week 24 p < 0.0001 p < 0.0001 91% decrease 94% decrease 3.2 0.3 0.2 0 0.5 1 1.5 2 2.5 3 3.5 Treatment Group Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83)

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13 September 2014 10 ACTRIMS-ECTRIMS 2014 Secondary Endpoint (2): Cumulative Number of New or Enlarging T2 Lesions From Weeks 12 to 24 p < 0.0001 p < 0.0001 84% decrease 91% decrease 9.0 1.4 0.8 0 2 4 6 8 10 12 Treatment Group Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83)

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13 September 2014 11 ACTRIMS-ECTRIMS 2014 Secondary Endpoint (3): Annualized Relapse Rate p = 0.271 31% decrease p = 0.053 53% decrease 0.5 0.35 0.24 0 0.1 0.2 0.3 0.4 0.5 0.6 Treatment Group Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83)

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13 September 2014 12 ACTRIMS-ECTRIMS 2014 Pharmacodynamic Effect of RPC1063: Mean ± SE Percent Change in Absolute Lymphocyte Counts 0 4 12 24 Study Week 0 -20 -40 -60 50% 60% Program: E:SASDatarpc1063201acsrprogg_lymph.sas 08JUN2014 ~ ~

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13 September 2014 13 ACTRIMS-ECTRIMS 2014 SAFETY: Treatment Emergent Adverse Events, n (%) (All 24-week Double blind phase) Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83) Number of subjects experiencing 1 TEAE 52 (59.1) 56 (64.4) 47 (56.6) 1 moderate or severe TEAE 23 (26.1) 24 (27.6) 13 (15.7) 1 severe TEAE 1  (1.1) 2  (2.3) 1  (1.2) 1 possible, probable, or related TEAE 11 (12.5) 19 (21.8) 15 (18.1) 1 related TEAE 1  (1.1) 1  (1.1) 0 Preferred Term Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83) Nasopharyngitis 12 (13.6%) 11 (12.6%) 5 (6.0%) Headache 8 (9.1%) 5 (5.7%) 3 (3.6%) Urinary Tract Infection 2 (2.3%) 6 (6.9%) 2 (2.4%) Most Common TEAEs  in RPC1063-treated Patients

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13 September 2014 14 ACTRIMS-ECTRIMS 2014 SAFETY: Serious TEAEs Only 3 Serious TEAEs (reported as unrelated) during the study *No change in EDSS post IV methyprednisolone treatment; did not qualify as a protocol-defined relapse but was considered related to the patient’s MS Preferred Term Placebo (N=88) n (%) RPC1063 0.5 mg (N=87) n (%) RPC1063 1 mg (N=83) n (%) Total number of Serious TEAEs 0 3 0 Number of Subjects with 1 Serious TEAE 0 3  (3.4) 0 Optic neuritis* 0 1 (1.1) 0 Somatoform autonomic dysfunction 0 1  (1.1) 0 Uterine cervical squamous metaplasia 0 1  (1.1) 0

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13 September 2014 15 ACTRIMS-ECTRIMS 2014 SAFETY: Non-Serious TEAEs No notable cardiac, pulmonary, ophthalmologic, infectious or malignancy TEAEs were observed 3 TEAEs of elevated liver enzymes ( 3x ULN) without clinical signs/symptoms were observed All were isolated ALT elevations (without AST or Bilirubin elevations) None 5x ULN Transient elevations despite continued treatment Parameter Placebo (N=87) RPC1063 0.5 mg (N=85) RPC1063 1 mg (N=83) Alanine Aminotransferase (ALT) 3x ULN, n (%) 0 2 (2.4%) 1 (1.2%) Aspartate Aminotransferase (AST) 3x ULN, n (%) 0 0 0

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13 September 2014 16 ACTRIMS-ECTRIMS 2014 Placebo (N=88) RPC1063 0.25 mg (N=170) Subjects with 2 nd Degree AVB, type I 2 (2.3%) 4 (2.4%) Subjects with Sinus Pause ( 2 seconds) 1 (1.1%) 1 (0.6%) Day 1: Cardiac Findings on 24-hr Holter SYSTEM ORGAN CLASS Preferred Term Placebo (N=88) RPC1063 0.5 mg (N=87) RPC1063 1 mg (N=83) CARDIAC DISORDERS 2  (2.3%) 2  (2.3%) 1  (1.2%) Angina Pectoris 0 0 1  (1.2%) First Degree AV Block 1  (1.1%) 0 0 Palpitations 1  (1.1%) 2  (2.3%) 0 Overall Incidence of Cardiac TEAEs Cardiac Safety Profile of RPC1063

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13 September 2014 17 ACTRIMS-ECTRIMS 2014 Conclusions Both doses of RPC1063 demonstrated large, significant and consistent reductions of all MRI measures of MS disease activity The overall tolerability and safety profile of RPC1063, including cardiac and hepatic safety results, suggests a favorable risk-benefit profile in the treatment of RMS These results support the ongoing Phase 3 portion of the RADIANCE trial and the second Phase 3 trial of RPC1063 vs. IFN -1a in RMS (SUNBEAM)