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 21, 2015

 

 

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.)

3033 Science Park Road, Suite 300

San Diego, California 92121

(858) 652-5700

(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))

 

 

 


Item 7.01. Regulation FD Disclosure.

On February 21, 2015, Receptos, Inc. (the “Company”) reviewed in further detail the data from the induction period of its TOUCHSTONE trial, the Company’s Phase 2 study of ozanimod (RPC1063) in Ulcerative Colitis, in a presentation at a meeting of the European Crohn’s and Colitis Organization in Barcelona, Spain. The slides used at the presentation are 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 February 21, 2015.

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.

 

2


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: February 23, 2015 RECEPTOS, INC.
By:

/s/ Christian Waage

Christian Waage
SVP & General Counsel

 

3


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    Corporate slide presentation of Receptos, Inc. dated February 21, 2015.

EX-99.1
A Randomized, Double-Blind, Placebo-Controlled Induction
Trial of an Oral S1P Receptor Modulator Ozanimod
(RPC1063) in Moderate to Severe Ulcerative Colitis:
Results of the TOUCHSTONE Study
William Sandborn, MD
21 February 2015
Barcelona, Spain
W.
Sandborn¹,
B.
Feagan²,
D.
Wolf³,
G.
D'Haens
4
,
S.
Vermeire
5
,
S.
Hanauer
6
,
S. Ghosh
7
, H. Smith
8
, M. Cravets
8
, P. Frohna
8
, S. Gujrathi
8
, A. Olson
8
1
University of California San Diego, Division of Gastroenterology, La Jolla, United States
2
University of Western Ontario, Department of Gastroenterology, London, Canada
3
Atlanta Gastroenterology Associates, Emory Saint Joseph's, Atlanta, United States
4
Academic Medical Centre, Inflammatory Bowel Disease Centre, Amsterdam, Netherlands
5
University Hospital Leuven, Department of Gastroenterology, Leuven, Belgium
6
Northwestern University Feinberg School of Medicine, Digestive Health Center, Chicago, United States
7
University of Calgary, Department of Gastroenterology, Alberta, Canada
8
Receptos, Inc., Clinical Development, San Diego, United States
Exhibit 99.1


Conflict of Interest Statements
W Sandborn-
Financial support for research: Receptos, Jansen, Abbvie, Prometheus
Laboratories, Pfizer, Amgen, Genentech, Takeda. Consultancy: Receptos, Jansen, Abbvie, UCB
Pharma, Shire, Salix, Actavis, Prometheus Laboratories, Pfizer, Amgen, Genentech, Takeda
B Feagan-
Consultancy: AbbVie, Actogenix, Albireo, Amgen, AstraZeneca, Avaxia Biologics,
Baxter, Biogen Idec, Boehringer-Ingelheim, BMS, Calypso, Celgene, Elan, EnGene, Ferring
Pharma, Roche/Genentech, GiCare, Gilead, Given Imaging, GSK, Ironwood, Janssen, JnJ,
Lexicon, Lilly, Merck, Millennium, Nektar, Novonordisk, Pfizer, Prometheus, Protagonist,
Receptos, Sanofi, UCB. Directorship: Robarts Clinical Trials
D Wolf-
Financial support for research: AbbVie, Amgen, Elan, Given Imaging, Genentech,
Janssen, Millennium, Pfizer, Prometheus, Receptos, UCB. Lecture fees: AbbVie, Janssen,
Prometheus, Santarus, Salix, Takeda, UCB. Consultancy: AbbVie, Genentech, Given Imaging,
Janssen, Prometheus, Salix, Takeda, UCB
G D’Haens-
Consultancy: Abbvie, Ablynx, Actogenix, Amgen, AM Pharma, AstraZeneca,
Boerhinger Ingelheim, Cosmo, Elan, Ferring, DrFALK Pharma, Celgene, Celltrion, Janssen,
Engene,
Galapagos,
Giuliani,
GivenImaging,
GSK,
Hospira,
Takeda,
Mitsubishi
Pharma,
MSD,
Mundipharma,
Novonordisk,
Norgine,
Otsuka,
Pfizer,
Photopill,
PDL,
Prometheus,
Receptos,
Robarts, Salix, Sandoz, Setpoint, Shire, TEVA, Tigenix, Tillotts, UCB, Versant, Vifor
S Vermeire-
Financial support for research: Abbvie, MSD, Centocor. Consultancy: Abbvie, MSD,
Takeda,
Pfizer,
Genentech/Roche,Ferring,
Mundipharma,
Receptos
S Hanauer-
Consultancy: Receptos, AbbVie, Janssen, UCB, Shire, Actavis, Salix, BMS, Merck,
Pfizer, Boehringer-Ingelheim, Sanofi-Aventis, Ferring, Celgene, Caremark
S Ghosh-
Financial support for research: Abbvie. Lecture fees: Abbvie, MSD. Consultancy:
Pfizer, Novo Nordisk BMS , Janssen, Abbvie, Receptos
H Smith,
M
Cravets,
P
Frohna,
S
Gujrathi,
and
A
Olson
are
full-time
employees
of
Receptos


S1P
1R
signaling on CCR7+
lymphocytes (central
memory T cells) facilitate
their exit from lymph nodes 
along an S1P gradient
Ozanimod induces S1P
1R
internalization so
lymphocytes do not respond
to S1P and are retained in
the lymph node
Protective immunity is
generally preserved since
CCR7-
lymphocytes (effector
memory T cells) do not
circulate through the lymph
nodes
S1P
1R
Modulation Results in Sequestration
of Select Lymphocyte Subsets


S1P
1R
Modulators
Fingolimod
is
the
first
S1P
receptor
modulator
(S1P
1,3,4,5R
)
and
oral
agent approved in 2010 for the treatment of Relapsing Multiple
Sclerosis (RMS)
Well established efficacy and safety profile
Over 100,000 patients have been treated with Fingolimod
No increase in serious infections, opportunistic infections, TB,
PML or malignancies over time
Warnings and Precautions include first dose cardiac effects (HR
reduction and cardiac conduction abnormalities), LFT elevations,
and macular edema
Ozanimod
(RPC1063)
is
a
next
generation
oral
S1P
receptor
modulator
Increased
selectivity
for
the
S1P
1R
and
S1P
5R
Improved pharmaceutic properties that allow for enhanced tissue
penetration and faster clearance
Demonstrated efficacy in a Phase 2 trial in RMS patients
Clinical trial experience to date has demonstrated an improved
cardiovascular
profile,
reduced
LFT
elevations,
no
macular
edema
and rapid lymphocyte recovery


Patient Population: Key Inclusion/Exclusion
Criteria
Inclusion:
Adults with moderate to severe UC defined by a Mayo score of 6-
12 inclusive with endoscopic subscore
2 by central read
Receiving treatment with oral aminosalicylates and/or prednisone
Patients were allowed to receive MTX, 6-MP or AZA until the day
of dosing with Ozanimod
Exclusion:
Treatment with biologics within 5 half-lives
History of clinically relevant cardiovascular disease
Resting heart rate
55 bpm


Study Design
Induction Period
Maintenance Period
Randomization
Placebo (N=65)
Ozanimod 0.5 mg (N=65)
Ozanimod 1 mg (N=67)
Mayo Responders
Open-Label
Primary
Endpoint:
Induction
Disease
Relapse
Week 32
Maintenance
Endpoint
1 Week Dose
Titration
8 Weeks
Treatment
24 Weeks
Treatment
Conducted at 57 sites in 13 countries
Induction period completion rate: 95%


Study Endpoints and Methods
Primary Efficacy Endpoint
Proportion of patients in clinical remission at Week 8,
defined as a Mayo score
2 points with no subscore > 1
point
Key Secondary Efficacy Endpoints
Proportion of patients with clinical response at Week 8
Change from Baseline in Mayo score at Week 8
Proportion of patients with mucosal improvement/mucosal
healing (endoscopic subscore
1)
Methods
All endoscopies were read centrally by a blinded evaluator
for both eligibility confirmation and endpoint scoring
Subjects with different central and local endoscopic sub-
scores had an additional central read and adjudication


Patient Demographics and UC Disease History
Placebo
(N=65)
Ozanimod 0.5 mg
(N=65)
Ozanimod 1 mg
(N=67)
Demographics
Male –
n (%)
35 (53.8)
32 (49.2)
48 (71.6)
Age (years)
mean (SD)
41.9 (12.3)
38.8 (12.1)
41.8 (11.0)
UC Disease History
Years
since
UC
diagnosis
mean
(SD)
6.1 (5.5)
5.9 (5.4)
6.7 (6.8)
Mayo
Score
by
central
read
mean
(SD)
8.6 (1.5)
8.3 (1.5)
8.5 (1.6)
Prior anti-TNF medication –
n (%)
10 (15.4)
12 (18.5)
15 (22.4)
Prior
use
of
AZA/6-MP/MTX
n
(%)
17 (26.2)
24 (36.9)
22 (32.8)
Baseline
use
of
corticosteroids
n
(%)
23 (35.4)
22 (33.8)
26 (38.8)


Endpoint: Proportion of Patients in Remission at
Week 8 (Adjudicated Central Read)
p = 0.1422
p = 0.0482
6.2%
13.8%
16.4%
0%
5%
10%
15%
20%
Treatment Group
Placebo (N=65)
Ozanimod 0.5 mg (N=65)
Ozanimod 1 mg (N=67)


p = 0.0698
p = 0.0114
p = 0.1422
p = 0.0482
Comparison of 1°
Endpoint: Original Central Read vs.
Adjudicated Central Read
4.6%
6.2%
13.8%
13.8%
17.9%
16.4%
0%
5%
10%
15%
20%
Original Central Read
Adjudicated Central Read
Placebo (N=65)
Ozanimod 0.5 mg (N=65)
Ozanimod 1 mg (N=67)


Endpoint: Proportion of Patients in Clinical Response
at Week 8 (Adjudicated Central Read)
p = 0.0648
p = 0.0140
36.9%
53.8%
58.2%
0%
10%
20%
30%
40%
50%
60%
70%
Treatment Group
Placebo (N=65)
Ozanimod 0.5 mg (N=65)
Ozanimod 1 mg (N=67)


Endpoint:
Proportion
of
Patients
With
Mucosal
Improvement/Mucosal
Healing
(Endoscopy
score
of
1
at
Week
8,
Adjudicated
Central
Read)
p = 0.0348
p = 0.0023
12.3%
27.7%
34.3%
0%
10%
20%
30%
40%
Treatment Group
Placebo (N=65)
Ozanimod 0.5 mg (N=65)
Ozanimod 1 mg (N=67)


Safety: Treatment Emergent Adverse Events
Number of Subjects
Placebo
(N=65)
Ozanimod 0.5 mg
(N=65)
Ozanimod 1 mg
(N=67)
1 TEAE
22 (33.8)
23 (35.4)
19 (28.4)
Most Common TEAEs
Placebo
Ozanimod 0.5 mg
Ozanimod 1 mg
Anemia / Decreased HgB
4 (6.2)
4 (4.6)
0
Worsening of UC
3 (4.6)
2 (3.1)
1 (1.5)
Serious TEAEs
Placebo
Ozanimod 0.5 mg
Ozanimod 1 mg
Number of Subjects with
1 Serious TEAE
4 (6.2)
1 (1.5)
1 (1.5)
Colitis ulcerative
2 (3.1)
0
1 (1.5)
Hyperpyrexia
0
1 (1.5)
0
Iron deficiency anemia
1 (1.5)
0
0
Jaundice (due to cholestasis)
1 (1.5)
0
0


No notable cardiac, ophthalmologic, or infectious TEAEs observed
24-hr Holter Monitoring Findings
Placebo
(n=65)
Ozanimod 0.25 mg
(n=132)
Subjects with 2
Degree AVB
0
0
Subjects with Sinus Pause
0
0
Safety: Holter Monitoring and Transaminase
Elevations
ALT elevation > 3xULN
Placebo
(n=65)
Ozanimod 0.5 mg
(n=65)
Ozanimod 1 mg
(n=67)
ALT elevation
0
2 (3.1)
1 (1.6)
ALT
elevations
were
asymptomatic,
transient,
not
associated
with
elevations
in
bilirubin
and
improved
while receiving Ozanimod
nd


Conclusions
Ozanimod
1
mg
induced
clinical
remission
at
Week
8
(1
°
EP)
All 3 secondary endpoints were met for Ozanimod 1 mg at Week 8
Proportion of patients with a clinical response
Change from baseline in Mayo score
Proportion of patients with mucosal improvement
A dose response relationship was observed for all primary and key
secondary efficacy endpoints
Ozanimod was well tolerated with a favorable benefit-risk profile