N4 Pharma PLC Clinical trials preliminary results (9691T)
July 09 2018 - 2:00AM
UK Regulatory
TIDMN4P
RNS Number : 9691T
N4 Pharma PLC
09 July 2018
9 July 2018
N4 Pharma Plc
("N4 Pharma" or the "Company")
Sildenafil Clinical Trial Preliminary Results Update
N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company
which reformulates existing drugs and vaccines to improve their
performance, announces the initial findings from analysing the
preliminary results of the pharmacokinetic ("PK") data from its
clinical trial for the reformulation of sildenafil.
Whilst the Company is yet to receive the full results from the
clinical trial, it is clear from the preliminary PK data that the
current formulation has not met the key target endpoints of the
trial. To that end, the product formulation will need to be
reviewed to assess what changes would be required to make the
reformulated drug viable in the context of the Company's patent
position.
Nigel Theobald, CEO of N4 Pharma, commented:
"This part of the process of drug reformulation is always going
to be a challenge and whilst this preliminary data is clearly
disappointing, we will need to see the full set of results expected
around the end of August to understand the detailed implications
for the formulation. We will provide a further update once we have
had a chance to review all the findings from the trial about the
next steps we will take to reformulate the product.
"Our nuvec(R) development program continues as planned and as
advised earlier we will release further news on these results in Q4
of this year."
Enquiries:
N4 PharmaPlc
Nigel Theobald, Via Alma PR
CEO
Stockdale Securities Tel: +44(0)207 601 6100
Tom Griffiths
Alma PR
Josh Royston Tel: +44(0)778 090 1979
Robyn Fisher Tel: +44(0)754 070 6191
About N4 Pharma
N4 Pharma is a specialist pharmaceutical company which
reformulates existing drugs and vaccines to improve their
performance.
N4 Pharma's reformulation work falls under two divisions:
-- generic, already commercialised, drugs; and
-- noveldelivery system for nucleic acids.
N4 Pharma has identified a number of established drugs that
could be improved upon through its reformulation techniques. N4
Pharma's most advanced reformulation is for sildenafil, widely
marketed as Viagra, where N4 Pharma is seeking to improve the speed
at which the drug takes effect whilst also extending its duration
of action.
N4 Pharma's reformulation approach should take approximately
three years to obtain regulatory approval as opposed to the
traditional process for new drugs of on average ten years. The cost
and risk profile of this model is also significantly less than the
traditional process. N4 Pharma's business model for generics is to
take reformulated drugs from its portfolio through to the stage
where it will license its newly reformulated drugs to
pharmaceutical companies to commercialise them. N4 Pharma's
revenues should be derived from up front milestone and royalty
payments associated with the licence.
N4 Pharma's business model for Nuvec(R) nanoparticles is to
undertake the required pre-clinical work to demonstrate the
capability of its nucleic acid delivery system as part of a vaccine
and/or method to deliver DNA/RNA so that it can license the
technology to major players developing treatments in this area,
again in return for up front milestone and royalty payments
associated with the licence.
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END
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