Summit Completes Initial 24 Weeks of Dosing of Ezutromid in Patients With DMD in PhaseOut DMD Clinical Trial
November 20 2017 - 7:00AM
- 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)Erik Ostrowski / Michelle Avery (US office)
|
Tel: +44 (0)1235 443 951 +1 617 225 4455 |
Cairn Financial Advisers LLP
(Nominated Adviser)Liam Murray / Tony Rawlinson |
Tel:
+44 (0)20 7213 0880 |
N+1 Singer (Joint Broker)Aubrey Powell
/ Jen Boorer |
Tel:
+44 (0)20 7496 3000 |
Pamure Gordon (Joint Broker)Freddy
Crossley / Duncan Monteith, Corporate FinanceTom Salvesen,
Corporate Broking |
Tel:
+44 (0)20 7886 2500 |
|
|
MacDougall Biomedical Communications
(US)Karen Sharma |
Tel:
+1 781 235 3060ksharma@macbiocom.com |
Consilium Strategic Communications (UK) Mary-Jane
Elliott / Sue Stuart / Jessica Hodgson / Philippa Gardner |
Tel: +44 (0)20 3709
5700 summit@consilium-comms.com |
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Summit Forward-looking Statements
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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
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"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-
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