UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2016
Commission File Number 001-36866
SUMMIT
THERAPEUTICS PLC
(Translation of registrants name into English)
85b Park Drive
Milton
Park, Abingdon
Oxfordshire OX14 4RY
United Kingdom
(Address
of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
FORM
20-F x FORM 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T
Rule 101(b)(7): ¨
Indicate by check mark whether the registrant by furnishing the information
contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
YES ¨ NO
x
If Yes is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
On March 7, 2016, Summit Therapeutics plc issued a press release announcing additional positive data from
the CoDIFy Phase 2 clinical trial. The related press release is attached hereto as Exhibit 99.1.
The information contained in Exhibit 99.1 shall not be
deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act,
except as expressly set forth by specific reference in such a filing.
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,
thereunto duly authorized.
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SUMMIT THERAPEUTICS PLC |
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By: |
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/s/ Erik Ostrowski |
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Erik Ostrowski |
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Chief Financial Officer |
Date: March 7, 2016
EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Press Release dated March 7, 2016 |
Exhibit 99.1
Summit Therapeutics plc
(Summit or the Company)
SUMMIT
ANNOUNCES RIDINILAZOLE PRESERVES THE GUT MICROBIOME OF PATIENTS WITH C. DIFFICILE INFECTION IN PHASE 2 TRIAL
Oxford, UK, 7 March 2016
Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (CDI), announces additional positive data
from the CoDIFy Phase 2 clinical trial that show the narrow spectrum antibiotic ridinilazole preserves the gut microbiome in CDI patients while the standard of care, vancomycin, inflicts substantial and long-lasting damage on the gut microbiome.
CDI results from damage to the microbiome, and patients experience further collateral damage through the use of broad spectrum antibiotics to
treat CDI, leaving them vulnerable to recurrent disease, commented David R. Snydman, MD, FACP, FIDSA, Chief, Division of Geographic Medicine and Infectious Diseases and Hospital Epidemiologist of Tufts University School of
Medicine. New, selective antibiotics are needed to minimise these high recurrence rates, and ridinilazole demonstrates an exceptional ability to preserve a patients microbiome and allow the growth of protective bacteria,
which are vital to protecting against CDI.
Preliminary analysis of these new data show ridinilazole to be highly preserving of the gut
microbiome. Ridinilazole treated patients in CoDIFy exhibited no further damage to their microbiome during therapy with a proportion of patients showing initial evidence of recovery of key bacterial groups with roles in protecting from CDI. In stark
contrast, vancomycin treated patients suffered substantial damage to their gut microbiome during treatment and this persisted in many patients during the 30-day post treatment period.
These new results from the Phase 2 trial show ridinilazole preserves the patients microbiome while simultaneously working to eradicate the C.
difficile bacteria. The clinical data strongly suggest that ridinilazole treatment may be better able to protect against recurrent disease than the current standard of care, commented Glyn Edwards, Chief Executive Officer of Summit
Therapeutics. We believe this approach offers a clear advantage over conventional broad spectrum antibiotics currently used to treat CDI that cause substantial damage to the gut microbiome or approaches that aim to artificially
re-establish a damaged gut microbiome following antibiotic treatment.
As evidenced by our growing body of clinical and preclinical
data, we believe ridinilazole has the ideal profile to become a single therapeutic approach capable of both treating the initial infection and reducing the high rates of recurrent disease.
These key microbiome findings strongly support recently reported results from the Phase 2 CoDIFy trial that showed ridinilazole to be statistically superior
to vancomycin in sustained clinical response (SCR), a combined endpoint capturing both initial cure and rates of recurrent CDI, with the improved SCR rate following ridinilazole treatment being driven by a large numerical reduction in
recurrence. Full microbiome data are expected to be published at a scientific conference in due course.
About CoDIFy
CoDIFy was a double blind, randomized, active controlled, multi-centre, Phase 2 clinical trial that evaluated the efficacy of ridinilazole against vancomycin
in a total of 100 patients. Half of the patients received ridinilazole for ten days (200 mg, twice a day), and the remaining half received vancomycin for ten days (125 mg, four times a day). The results of the trial showed ridinilazole achieved
statistical superiority in SCR with rates of 66.7% compared to 42.4% for vancomycin. SCR is defined as cure at the end of therapy and no recurrent disease 30 days post end of therapy. The primary analysis was conducted on the modified
intent-to-treat (mITT) population that comprised subjects with CDI confirmed by the presence of free toxin. These additional data on the preserving effect ridinilazole had on the gut microbiome support the top-line Phase 2 data and
improvement observed in rates of recurrent disease.
Notes to Editors
About C. difficile Infection
C.
difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with between 450,000 and 700,000 cases of CDI in the US annually. It is caused by an infection of the colon by the
bacterium C. difficile, which produces toxins that cause inflammation, severe diarrhoea and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread
damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad spectrum antibiotics, and these cause further damage to the gut flora and are associated with
high rates of recurrent disease. Recurrent disease is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. The economic impact of CDI is significant with one
study estimating annual acute care costs at $4.8 billion in the US.
About Ridinilazole
Ridinilazole (SMT19969) is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical
efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed
statistical superiority in sustained clinical response (SCR) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of
therapy. Ridinilazole has received Qualified Infectious Disease Product (QIDP) designation and has been granted Fast Track status by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and
include an extension of marketing exclusivity for an additional five years upon FDA approval.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no
existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com
and Summit can be followed on Twitter (@summitplc).
For more information, please contact:
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Summit Glyn Edwards / Richard Pye (UK
office) Erik Ostrowski / Michelle Avery (US office) |
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Tel: +44 (0)1235 443 951
+1 617 225 4455 |
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Cairn Financial Advisers LLP (Nominated
Adviser) Liam Murray / Tony Rawlinson |
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Tel: +44 (0)20 7148 7900 |
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N+1 Singer (Broker)
Aubrey Powell / Jen Boorer |
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Tel: +44 (0)20 7496 3000 |
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Peckwater PR (Financial public
relations, UK) Tarquin Edwards |
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Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk |
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MacDougall Biomedical Communications (US
media contact) Chris Erdman |
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Tel: +1 781 235 3060
cerdman@macbiocom.com |
Forward-looking Statements
Any statements in this press release about Summits future expectations, plans and prospects, including but not limited to, statements about the clinical
and preclinical development of Summits product candidates, the therapeutic potential of Summits product candidates, and the timing of initiation, completion and availability of data from clinical trials, and other statements containing
the words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict,
project, should, target, would, and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from on-going and future
clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the
results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summits foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the
Risk Factors section of filings that Summit makes with the Securities and Exchange Commission including Summits Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue
reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summits views only as of the date of this release and should not be relied upon as representing
Summits views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.
-END-
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