Summit Announces PhaseOut DMD Did Not Meet Primary Endpoint
27 Juin 2018 - 1:00PM
Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT) today announces
PhaseOut DMD has not met its primary or secondary endpoints after
48 weeks of treatment of ezutromid in patients with Duchenne
muscular dystrophy (‘DMD’). PhaseOut DMD was a multi-centre,
open-label Phase 2 clinical trial of the utrophin modulator,
ezutromid.
Based on this outcome, the Company is
discontinuing its development of ezutromid and as a result, will be
implementing cost reduction measures. Summit will now focus its
operations on the development of its pipeline of new mechanism
antibiotics. The Company’s lead product candidate, ridinilazole, is
expected to enter Phase 3 clinical trials for the treatment of C.
difficile infection in Q1 2019.
“These data come as a great disappointment to us
and to all those living with DMD,” said Glyn Edwards, Chief
Executive Officer of Summit. “While we believe utrophin
modulation could still have a place in the treatment of DMD, it is
clear that ezutromid is not providing a benefit for patients. We
therefore feel that our resources are better focussed on the
development of our promising pipeline of new mechanism
antibiotics.
“We sincerely thank the patients, families and
clinical trial sites involved in all of the ezutromid clinical
trials for their commitment to advancing research in DMD. We hope
that the information we have gathered can ultimately be used to
benefit ongoing research in DMD.”
Summit is currently working with the clinical
trial investigators in PhaseOut DMD to bring the trial and
associated extension phase to a conclusion. The Company plans to
also explore ways that information gathered as part of PhaseOut DMD
can be made available to support other research activities in DMD
for the benefit of the DMD community.
About PhaseOut DMD A total of
40 boys with DMD were enrolled in PhaseOut DMD, with 38 completing
the 48-week clinical trial. Ezutromid was dosed twice a day at
either 1000 mg (F6 formulation) or 2500 mg (F3 formulation). The
primary endpoint was the change from baseline in magnetic resonance
parameters related to the leg muscles. Biopsy measures evaluating
utrophin and muscle damage were included as secondary endpoints,
with patients having two biopsies: one at baseline and their second
after either 24 weeks or 48 weeks of ezutromid treatment.
Exploratory endpoints included the six-minute walk distance, the
North Star Ambulatory Assessment and patient reported outcomes.
While statistical decreases in developmental myosin and magnetic
resonance T2 measures were seen after 24 weeks of treatment, these
effects were not seen after 48 weeks of treatment. Ezutromid was
generally well-tolerated in the trial.
Conference Call DetailsSummit
will host a conference call and webcast to review the data today at
8:00am EDT / 1:00pm BST. To participate in the conference call,
please dial +1 929-477-0402 (US local number) or +44 (0)330 336
9126 (UK and international participants) and use the conference
confirmation code 7830699. Investors may also access a live audio
webcast of the call via the investors section of the Company’s
website www.summitplc.com. A replay of the webcast will be
available shortly after the completion of the call.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery,
development and commercialisation of novel medicines for which
there are no existing or only inadequate therapies. Summit’s
clinical programmes focus on the infectious disease C.
difficile infection and the neuromuscular disease Duchenne
muscular dystrophy. Further information is available at
www.summitplc.com and Summit can be followed on Twitter
(@summitplc).
For more information, please contact:
Summit |
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Glyn
Edwards / Richard Pye (UK office) |
Tel: |
44
(0)1235 443 951 |
Erik
Ostrowski / Michelle Avery (US office) |
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+1
617 225 4455 |
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Cairn Financial Advisers LLP (Nominated
Adviser) |
Tel: |
+44
(0)20 7213 0880 |
Liam
Murray / Tony Rawlinson |
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N+1 Singer (Joint Broker) |
Tel: |
+44
(0)20 7496 3000 |
Aubrey Powell / Jen Boorer |
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Panmure Gordon (Joint Broker) |
Tel: |
+44
(0)20 7886 2500 |
Freddy Crossley |
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MSL Group (US) |
Tel: |
+1
617 684 6557 |
Jon
Siegal |
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Jon.siegal@mslgroup.com |
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Consilium Strategic Communications (UK) |
Tel: |
+44
(0)20 3709 5700 |
Mary-Jane Elliott / Jessica Hodgson / |
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summit@consilium-comms.com |
Lindsey Neville |
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Forward-looking StatementsAny
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 implementation of cost reduction measures, 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 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 2018. 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).
Summit Therapeutics (NASDAQ:SMMT)
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