Current Report Filing (8-k)
September 15 2014 - 8:05AM
Edgar (US Regulatory)
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)
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Delaware |
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001-35900 |
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26-4190792 |
(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.) |
10835 Road to the Cure, Suite 205
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 September 13, 2014, Receptos, Inc. (the
Company) reviewed in further detail the data from the Phase 2 portion of RADIANCE, the Companys 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.
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Exhibit
No. |
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Description |
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99.1 |
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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.
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Date: September 15, 2014 |
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RECEPTOS, INC. |
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By: |
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/s/ Christian Waage |
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Christian Waage |
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SVP & 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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Slide presentation of Receptos, Inc. dated September 13, 2014. |
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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
patients 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) |
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