Summit Completes Dosing of Ezutromid in PhaseOut DMD Clinical Trial
April 19 2018 - 6:00AM
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) announces the
completion of ezutromid dosing in patients with Duchenne muscular
dystrophy (‘DMD’) for the full 48-week PhaseOut DMD clinical trial.
Top-line data from the full trial continue to be expected in the
third quarter of 2018.
“We believe the early improvements seen in
muscle health in the interim data from PhaseOut DMD indicate
ezutromid is reducing DMD disease severity. In the full trial
results, we aim to see continued utrophin modulation and sustained
changes in magnetic resonance parameters,” said Dr David
Roblin, Chief Medical Officer and President of R&D of
Summit. “These results, if positive, could form the basis
of a regulatory filing of ezutromid, bringing this universal
treatment to patients more rapidly.”
PhaseOut DMD is a Phase 2 open-label,
multi-centre trial of the Company’s utrophin modulator, ezutromid,
in patients with DMD. Previously announced 24-week interim data
from PhaseOut DMD showed evidence of activity across three
different measures. Specifically, ezutromid:
- Maintained the production of utrophin, a naturally occurring
protein that can potentially substitute for dystrophin, as measured
by muscle biopsy;
- Significantly and meaningfully reduced muscle damage, as
measured by muscle biopsy; and
- Significantly reduced muscle inflammation, as measured by
magnetic resonance.
About Utrophin Modulation in
DMD DMD is the most common and severe form of muscular
dystrophy, impacting 50,000 patients in the developed world alone.
DMD is caused by the lack of dystrophin, a protein that maintains
healthy muscle function. The absence of dystrophin results in a
catastrophic cycle of muscle damage and repair that leads to
progressive loss of functional ability and ultimately in premature
death.
Utrophin and dystrophin play a similar role in
maintaining muscle function, but do so at different times. Utrophin
plays this role when new muscle fibres are being formed, or when
damaged fibres are being repaired, but then switches off to make
way for dystrophin to perform this role in mature muscle fibres.
Since patients with DMD are not able to produce dystrophin, a cycle
of muscle damage and repair occurs, which eventually leads to
muscle fibre failure. Utrophin modulation aims to address the root
cause of DMD by maintaining the production of utrophin to
substitute for the missing dystrophin. The presence of utrophin in
mature muscle fibres could break the cycle of damage and repair and
ultimately slow, or even stop, disease progression. Importantly,
this approach has the potential to treat all patients with DMD
regardless of their underlying dystrophin gene mutation.
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 PhaseOut DMD PhaseOut DMD
is an open-label, multi-centre trial that has enrolled 40 patients
in the US and UK, aged from their fifth to their tenth birthdays.
PhaseOut DMD is 48 weeks in length after which patients have the
option of enrolling into an extension phase and continuing to be
dosed with ezutromid. The primary endpoint is the change from
baseline in magnetic resonance parameters related to the leg
muscles. Biopsy measures evaluating utrophin and muscle damage are
included as secondary endpoints. Exploratory endpoints include the
six-minute walk distance, the North Star Ambulatory Assessment and
patient reported outcomes.
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).
This announcement contains inside information
for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
Contacts
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) |
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+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, Corporate Finance |
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Tom
Salvesen, Corporate Broking |
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MacDougall Biomedical Communications (US) |
Tel: |
+1
781 235 3060 |
Karen
Sharma |
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ksharma@macbiocom.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 |
Philippa Gardner |
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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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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.
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