Oxford Pharmascience Group PLC Company Update (6402X)
February 23 2017 - 2:02AM
UK Regulatory
TIDMOXP
RNS Number : 6402X
Oxford Pharmascience Group PLC
23 February 2017
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
OXPzero(TM) Ibuprofen - Positive Exploratory PK Study Data
Oxford Pharmascience (AIM: OXP), the specialty pharmaceutical
company that redevelops medicines to make them better, safer and
easier to take, provides the following update on its lead
OXPzero(TM) Ibuprofen clinical programme.
On 17 January 2017 the Company confirmed that it had started
dosing of healthy subjects in its Phase I exploratory
pharmacokinetic (PK) study "OAT-01", as previously outlined in an
earlier announcement dated 9 November 2016. OAT-01 is a three-part,
open label, active controlled, crossover study designed to assess
the PK profile of the lead OXPzero(TM) Ibuprofen technology
modifications against licensed ibuprofen products to verify that
the improvements in speed of ibuprofen release seen in laboratory
studies translate into improvements in healthy human subjects.
Interim PK data from the first part of the study in 10 subjects
indicate that the technology modifications can successfully change
the PK profile of ibuprofen released into the body from OXPzero(TM)
Ibuprofen and that it is possible to achieve a PK profile
comparable to Nurofen(TM) (a licensed over-the-counter ibuprofen
product) displaying:
-- equivalent maximum plasma levels (Cmax);
-- equivalent total absorption of ibuprofen (AUC); and
-- a faster rate of absorption (Tmax) (i.e. onset of efficacy).
In addition, alternative technology modifications are able to
achieve a PK profile for OXPzero(TM) Ibuprofen with a slower rate
of release and extended duration of effect as compared to
Nurofen(TM) .
The OAT-01 study will continue as planned to further elucidate
the range of impact on PK by the technology modifications. Further
data from this study will help select the optimal technology
modifications to guide subsequent formulation development of
over-the-counter and prescription strength products. The Company do
not intend to announce further OAT-01 study results since details
of the technology modifications are the subject of a recently filed
UK patent application with international filings to be expanded
over the next two years as the UK application progresses. Further
details on the OAT-01 study can be found at ClinicalTrials.gov
using the identifier NCT02974361.
Commenting on the results, CEO Marcelo Bravo said:
"Oxford Pharmascience is very pleased with these exploratory,
interim PK study results, which demonstrate that the technolology
modifications can not only make OXPzero(TM) Ibuprofen bioequivalent
to ibuprofen free acid (Nurofen(TM) ), but also potentially faster
acting. Achieving a product that is bioequivalent to reference is
highly important to OXP as the regulatory pathway to gaining
product approval generally becomes faster, simpler and therefore
less costly for bioequivalent products. The potential to accelerate
speed of action or to extend the duration of effect is expected to
further differentiate prospective OXPzero(TM) products.
"These results indicate a strong position with an OXPzero(TM)
Ibuprofen asset that can be made bioequivalent, completely taste
masked and either faster acting or having an extended duration of
effect compared to the reference product."
This announcement contains inside information.
For further information please contact:
Oxford Pharmascience Group Plc
Marcelo Bravo, Chief Executive +44 20 7554 5875
N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell/Lauren Kettle +44 20 7496 3000
About Oxford Pharmascience Group Plc
Oxford Pharmascience Group Plc uses a range of proprietary
technology platforms to re-develop existing medicines to make them
better, safer or easier to take. The Company does not manufacture
or sell its own pharmaceutical products direct to consumers but
instead seeks to license its technologies and dossiers to a network
of partners, mainly leading pharmaceutical companies with Rx
(prescription) and OTC (Over the Counter) branded portfolios.
Oxford Pharmascience Group Plc focuses on existing medicines
that are proven to be safe and effective but nevertheless still
have associated issues and side effects often affecting compliance.
By working with such medicines the Company is able to develop new
innovative products for a fraction of the cost, in much quicker
timescales and without the high risk of failure associated with
developing new drugs.
About OXPzero(TM) non-steroidal anti-inflammatory drugs
(NSAIDs)
Specifically, by comparison with generic NSAIDs, OXPzero(TM)
Ibuprofen and OXPzero(TM) Naproxen are milder in the GI tract,
delivering major reduction in severe GI mucosal damage,
significantly mask the bitter taste/burn associated with NSAIDs,
and deliver an attractive pharmacokinetic profile with adaptable
drug release properties.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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