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 September 2015
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 September 10, 2015, Summit Therapeutics plc (the Company) issued a press release announcing
the completion of patient enrollment into its Phase 2 proof of concept trial of SMT19969 for the treatment of Clostridium difficile infection. The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
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.
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, 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: September 14, 2015
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 September 10, 2015 announcing completion of patient enrollment into Phase 2 proof of concept trial of SMT19969 |
Exhibit 99.1
Summit Therapeutics plc
(Summit or the Company)
SUMMIT
THERAPEUTICS COMPLETES TARGETED ENROLMENT FOR SMT19969 PHASE 2 TRIAL FOR C. DIFFICILE INFECTION
Oxford, UK, 10 September, 2015
Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection (CDI), today announced the
completion of patient enrolment into the CoDIFy Phase 2 proof of concept trial of SMT19969 for the treatment of CDI. Patient dosing and follow-up is continuing and top-line results are expected in the fourth quarter of 2015. SMT19969 is a novel,
oral antibiotic designed to selectively target C. difficile bacteria while not harming the gut microbiome that is essential in protecting against disease recurrence.
CDI is now widely accepted to be a major healthcare issue, and with current antibiotics used to treat CDI having high rates of disease recurrence, there
is an urgent need to develop new therapies,said Glyn Edwards, Chief Executive Officer of Summit. We believe SMT19969 represents an important advance as its potency in killing C. difficile bacteria is complemented by
selective targeting that leaves the healthy gut microbiome unharmed. The timely completion of enrolment into our CoDIFy proof of concept trial achieves an important milestone and means we remain on-track to report top-line results in the fourth
quarter of this year.
C. difficile is one of three pathogens that pose an immediate public health threat according to the US Center for
Disease Control and Prevention (CDC). CDI has a high economic impact with annual acute care costs estimated at $4.8 billion in the United States alone. The key clinical issue is disease recurrence with approximately 25% of patients
suffering recurrence of CDI, a risk that rises to 40% after a first recurrence and over 65% after a second recurrence.
SMT19969 has received Qualified
Infectious Disease Product designation (QIDP) and Fast Track status from the US Food and Drug Administration. The development of SMT19969 is being supported by a Wellcome Trust Translational Award.
About CoDIFy Phase 2 Clinical Trial
CoDIFy, is a double-
blind, randomized, active control Phase 2 trial evaluating the efficacy of SMT19969 against the current standard of care, vancomycin. CoDIFy is being conducted in the United States and Canada. The trial has enrolled a total of 100 patients, with
half receiving ten days of dosing with SMT19969, and half receiving ten days of dosing with vancomycin. The primary endpoint of the trial is sustained clinical response, a composite endpoint which is defined as clinical cure at the test of cure
visit with no recurrence of CDI within 30 days after the end of treatment. The trial is also examining a number of secondary endpoints, including the safety and tolerability of SMT19969 and its impact on patients gut microbiome.
About SMT19969
SMT19969 is a novel, oral small molecule
antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with high levels of antibacterial selectivity.
A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported, demonstrating that SMT19969 was highly
sparing of the gut microbiome.
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 Therapeutics Glyn Edwards /
Richard Pye (UK office) Erik Ostrowski (US office) |
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Tel: +44 (0)1235 443 951
+1 617 294 6607 |
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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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MacDougall Biomedical Communications
(US media contact) Michelle Avery |
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Tel: +1 781 235 3060
mavery@macbiocom.com |
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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 |
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, the timing of initiation, completion and availability of data from clinical trials and expectations regarding the
sufficiency of Summits cash balance to fund operating expenses and capital expenditures, 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.
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