Summit Therapeutics plc Summit Completes Initial 24 Weeks Of Dosing Of Ezutromid In Patients With Dmd In Phaseout Dmd Clinica...
November 20 2017 - 7:00AM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
("Summit" or the "Company")
SUMMIT COMPLETES INITIAL 24 WEEKS OF DOSING OF EZUTROMID IN PATIENTS
WITH DMD IN PhaseOut DMD CLINICAL TRIAL
-- Summit Continues to Expect 24-week Data Q1 2018, which Could Provide
Potential Proof of Mechanism for Ezutromid
Oxford, UK, 20 November 2017 - Summit Therapeutics plc (NASDAQ: SMMT,
AIM: SUMM) the drug discovery and development company advancing
therapies for Duchenne muscular dystrophy ('DMD') and Clostridium
difficile infection, announces the completion of the initial 24-weeks of
dosing of ezutromid in patients with DMD in the Company's Phase 2
clinical trial called PhaseOut DMD. With the achievement of this
milestone, Summit continues to expect to report results from this
initial 24-week dosing period in the first quarter of 2018.
The 24-week results are expected to include data from muscle biopsies,
MRI and functional tests, as well as safety data.
"With the completion of the 24-week dosing period, we remain on-track to
conduct the planned biopsy, MRI and functional analyses and deliver the
results for the initial dosing period during the first quarter of 2018,"
commented Dr David Roblin, Chief Operating Officer and Medical Officer
of Summit. "In the interim data readout, we aim to show a positive
change following ezutromid treatment in muscle structure and health
through the evaluation of muscle biopsies. This could potentially
provide the first evidence of proof of mechanism for utrophin modulators
in patients and give hope to those living with DMD."
PhaseOut DMD is a 48-week open-label Phase 2 clinical trial that has
enrolled 40 patients at sites in the UK and the US. The trial aims to
establish proof of concept of ezutromid and is evaluating a range of
muscle structure, muscle health and functional endpoints. As part of the
trial, each patient has two muscle biopsies taken; a baseline biopsy on
enrolment and a second either after 24 weeks or 48 weeks of dosing.
Top-line data from the complete 48-week trial are expected in the third
quarter of 2018. Following the 48 weeks of treatment, patients have the
option to continue onto an extension phase. The extension phase will be
used to gather long term safety and efficacy data and is expected to
last until ezutromid either receives marketing approval in the relevant
country or its development is discontinued.
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around 50,000
boys and young men in the developed world. The disease is caused by
different genetic faults in the gene that encodes dystrophin, a protein
that is essential for the healthy function of all muscles. There is
currently no cure for DMD and life expectancy is into the late twenties.
Utrophin protein is functionally and structurally similar to dystrophin.
In preclinical studies, the continued expression of utrophin had a
meaningful, positive effect on muscle performance. Summit believes that
utrophin modulation has the potential to slow down or even stop the
progression of DMD, regardless of the underlying dystrophin gene
mutation. Summit also believes that utrophin modulation could
potentially be complementary to other therapeutic approaches for DMD.
The Company's lead utrophin modulator, ezutromid, is an orally
administered, small molecule drug. DMD is an orphan disease, and the US
Food and Drug Administration ('FDA') and the European Medicines Agency
have granted orphan drug status to ezutromid. Orphan drugs receive a
number of benefits including additional regulatory support and a period
of market exclusivity following approval. In addition, ezutromid has
been granted Fast Track designation and Rare Pediatric Disease
designation by the FDA.
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 programmes 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).
Contacts
Summit
Glyn Edwards / Richard Pye (UK office) Tel: 44 (0)1235 443 951
Erik Ostrowski / Michelle Avery (US office) +1 617 225 4455
Cairn Financial Advisers LLP (Nominated
Adviser) Tel: +44 (0)20 7213 0880
Liam Murray / Tony Rawlinson
N+1 Singer (Joint Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
Pamure Gordon (Joint Broker) Tel: +44 (0)20 7886 2500
Freddy Crossley / Duncan Monteith,
Corporate Finance
Tom Salvesen, Corporate Broking
MacDougall Biomedical Communications (US) Tel: +1 781 235 3060
Karen Sharma ksharma@macbiocom.com
Consilium Strategic Communications (UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Sue Stuart / summit@consilium-comms.com
Jessica Hodgson / Philippa Gardner
Summit Forward-looking Statements
Any statements in this press release about the Company's future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of the
Company's product candidates, the therapeutic potential of the Company's
product candidates, the potential commercialisation of the Company's
product candidates, the sufficiency of the Company's cash resources, the
timing of initiation, completion and availability of data from clinical
trials, the potential submission of applications for marketing approvals
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 ongoing 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, laws and regulations affecting
government contracts, availability of funding sufficient for the
Company's foreseeable and unforeseeable operating expenses and capital
expenditure requirements and other factors discussed in the "Risk
Factors" section of filings that the Company makes with the Securities
and Exchange Commission, including the Company's Annual Report on Form
20-F for the fiscal year ended 31 January 2017. 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 the Company's views only as of the date of
this release and should not be relied upon as representing the Company's
views as of any subsequent date. The Company specifically disclaims any
obligation to update any forward-looking statements included in this
press release.
This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014 (MAR).
-END-
This announcement is distributed by Nasdaq Corporate Solutions on behalf
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
(END) Dow Jones Newswires
November 20, 2017 07:00 ET (12:00 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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