Summit Reports Positive Interim Data From Ongoing Phase 1 Clinical Trial Testing a New Formulation of SMT C1100 in Patients W...
30 March 2016 - 10:00PM
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 positive interim data from a Phase 1 clinical trial
evaluating a new oral formulation of its lead utrophin modulator,
SMT C1100, for DMD. In this dose escalating clinical trial’s
initial dosing period, all patients achieved plasma drug levels
within the range believed to be necessary for a potential
therapeutic benefit. The initial dose tested of the new formulation
was one tenth of that required with the current formulation of SMT
C1100 to achieve similar drug concentration levels in the recent
Phase 1b modified diet clinical trial of SMT C1100.
SMT C1100 is a potential disease-modifying
therapy for all patients with DMD and is progressing in its current
formulation into a Phase 2 proof of concept clinical trial.
“These initial data are encouraging regarding
the potential development of an improved formulation that could
achieve blood levels of SMT C1100 that are above those observed
with our current formulation,” said Ralf Rosskamp, MD,
Chief Medical Officer of Summit. “We have seen in a prior
Phase 1 clinical trial how a balanced diet enables our current
formulation to reach blood levels that we believe could provide
therapeutic benefit, and our ongoing new formulation development
work could provide more insight into the potential benefits of SMT
C1100 on utrophin modulation in patients with DMD.”
The new formulation Phase 1 clinical trial of
SMT C1100 is proceeding to evaluate a higher dose of the new
formulation. Firm decisions on further development of this new
formulation will await full data from the trial.
About the New Formulation Phase 1
Clinical Trial of SMT C1100The new formulation of SMT
C1100 Phase 1 clinical trial is comprised of two parts. Part A
tested two new oral formulations of SMT C1100 in 16 healthy male
volunteers. One of these new formulations, which achieved an over
ten-fold increase in plasma exposure in healthy volunteers compared
to the current formulation of SMT C1100, was selected to progress
into Part B of the trial.
Part B of the trial is assessing the
pharmacokinetics and safety of up to three dose levels of a new
formulation of SMT C1100 taken twice a day for seven days in eight
boys with DMD, aged five to nine years. In the initial dosing
period of the new formulation Phase 1 trial, patients who received
a 250 mg fixed dose of the new formulation of SMT C1100 for seven
days achieved plasma levels of the drug similar to those of
patients who received a 2,500 mg fixed dose of the current
formulation of SMT C1100 in the Phase 1b modified diet trial
completed in 2015. The new formulation of SMT C1100 was generally
well-tolerated in healthy volunteers and in the patients who
received the first dose level of the new formulation of SMT C1100.
Patients in this Phase 1 trial are following similar dietary
guidance to those in the prior Phase 1b modified diet trial.
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 has 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 is an orally
administered, small molecule called SMT C1100. DMD is an orphan
disease, and the US Food and Drug Administration and the European
Medicines Agency have granted orphan drug status to SMT C1100.
Orphan drugs receive a number of benefits including additional
regulatory support and a period of market exclusivity following
approval.
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:
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) |
|
Liam
Murray / Tony Rawlinson |
Tel:
+44 (0)20 77148 7900 |
|
|
N+1 Singer |
|
(Broker) |
|
Aubrey Powell / Jen Boorer |
Tel:
+44 (0)20 7496 3000 |
|
|
Peckwater PR |
|
(Financial public relations, UK) |
Tel:
+44 (0)7879 458 364 |
Tarquin Edwards |
tarquin.edwards@peckwaterpr.co.uk |
|
|
MacDougall Biomedical Communications |
|
(US
media contact) |
Tel:
+1 781 235 3060 |
Chris
Erdman |
cerdman@macbiocom.com |
Forward-looking Statements
Any statements in this press release about
Summit’s future expectations, plans and prospects, including but
not limited to, statements about the clinical and preclinical
development of Summit’s product candidates, the therapeutic
potential of Summit’s product candidates, and 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 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 Summit’s 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
Summit’s 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 Summit’s views only as of the date of this release and
should not be relied upon as representing Summit’s 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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