Mereo BioPharma Group plc Update on BGS-649 Phase 2b Study (7467P)
05 September 2017 - 4:00PM
UK Regulatory
TIDMMPH
RNS Number : 7467P
Mereo BioPharma Group plc
05 September 2017
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Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Update on BGS-649 Phase 2b Study
Completion of Patient Enrolment in Phase 2b dose-confirmation
study
of BGS-649 for the treatment of hypogonadotropic
hypogonadism
Top line results expected Q1 2018
London, 5 September 2017 - Mereo BioPharma Group plc (AIM: MPH),
a clinical stage, UK-based, biopharmaceutical company focused on
rare and specialty diseases, today announced, that it has
successfully completed patient enrolment in a Phase 2b
dose-confirmation study for the treatment of hypogonadotropic
hypogonadism (HH) in men with a body mass index of over 30. BGS-649
is a once a week oral aromatase inhibitor that restores a patient's
own testosterone to normal levels by inhibiting the conversion of
testosterone to oestradiol.
A total of 270 patients have been enrolled into a randomised
placebo controlled Phase 2b dose-confirmation study assessing three
different dosing regimens. This follows a positive outcome,
announced in March 2017, of a blinded interim review of the safety
and efficacy of all the three doses based on 93 patients who had
received at least one month's treatment.
The primary endpoint of this study is to demonstrate the
efficacy of BGS-649 to normalise total testosterone levels in over
75% of subjects after 24 weeks of treatment. Secondary endpoints
are based on the impact of BGS-649 on luteinising hormone (LH),
follicle stimulating hormone (FSH) and semen parameters. In
addition the company is exploring patient recorded outcomes
including sexual function and fatigue. Top-line data are expected
in the first quarter of 2018.
Additionally, a six-month extension study in up to 120 patients
to confirm the safety of long term treatment with BGS-649 is well
underway.
Alastair Mackinnon, Chief Medical Officer of Mereo BioPharma
Group plc commented:
"We are delighted to have completed enrolment in our Phase 2b
study for BGS-649, which is another important milestone in the
development of the Company. BGS-649 is highly differentiated from
current treatment options and those in development, which are based
on delivering exogenous testosterone. We believe that BGS-649 has
the potential to be an important new safe, effective and more
convenient treatment for the men suffering from this debilitating
condition. We look forward to announcing the top line results of
the trial in Q1 2018."
About Hypogonadotropic hypogonadism
Hypogonadotropic hypogonadism (HH) results from inadequate
levels of testosterone. Symptoms associated with testosterone
deficiency include reduced/loss of libido, erectile dysfunction,
tiredness, fatigue, impaired physical endurance, loss of vitality,
lack of motivation and mood disturbance. There are approximately
six million cases of HH in obese men in the US and approximately
four million cases in Europe. Current therapies for HH involve
direct replacement of testosterone administered by gel formulations
applied to the skin, which risk transference to anyone in close
contact, or intramuscular injections, which can be painful and
inconvenient. Exogenous testosterone replacement can impair male
fertility by suppressing luteinising hormone (LH) and follicle
stimulating hormone (FSH). BGS-649 is a once a week oral therapy
designed to be more convenient compared with current therapies and
due to its mechanism of action, is expected to restore normal
testosterone production without the risk of supra-physiological
levels or suppression of LH and FSH, thereby treating the symptoms
of HH whilst maintaining or improving testicular function.
For Further Enquiries:
Mereo BioPharma Group plc +44 (0)333 023 7319
Denise Scots-Knight, Chief
Executive Officer
Richard Jones, Chief Financial
Officer
Nominated Adviser and Joint
Broker
Cantor Fitzgerald Europe +44 (0)20 7894 7000
Phil Davies
Will Goode
Joint Broker
RBC Capital Markets +44 (0)20 7653 4000
Rupert Walford
Laura White
Public Relations Adviser to
Mereo Biopharma
FTI Consulting +44 (0)20 3727 1000
Ben Atwell
Simon Conway
Brett Pollard
US Public Relations Advisor
to Mereo Biopharma +01 (0) 212 213
Burns McClellan 0006
Lisa Burns
Steven Klass
About Mereo
Mereo BioPharma is an innovative biopharma company established
to address the R&D and financial challenges faced by an
increasing number of large pharma and biotech companies. Mereo
focuses on developing and optimizing the value of novel medicines
acquired from large pharma and biotech designed to address
significant unmet medical needs in rare and specialty disease
areas.
Mereo is comprised of a strong team with broad operational
capabilities and the financial resources to conduct comprehensive
clinical studies. The Company plans to build a rare and orphan
commercial business combined with plans to partner where
relevant.
Mereo's initial portfolio consists of three mid-late stage
clinical assets that were acquired from Novartis in July 2015 each
with proof of concept data in the indication that Mereo is now
developing. BPS-804 is being developed for the prevention of
fractures resulting from osteogenesis imperfecta (brittle bone
disease); acumapimod (BCT-197), is being developed to treat
inflammation in patients with an AECOPD; and BGS-649 is a
once-weekly oral novel therapy that restores the patient's own
testosterone in men with hypogonadotropic hypogonadism.
In H1 2016 the Company initiated a Phase 2 study with acumapimod
and a Phase 2b study with BGS-649. Mereo recently announced
commencement of the first potentially pivotal Phase 2b trial for
BPS-804 and completion of enrolment of the acumapimod Phase 2
study. Additional product opportunities, from a range of large
pharmaceutical and biotechnology companies, are under active
evaluation and these are focussed on orphan and rare diseases.
This information is provided by RNS
The company news service from the London Stock Exchange
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