Clinical trials preliminary results

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® 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, CEO	Via Alma PR
Stockdale Securities Tom Griffiths	Tel: [phone]
Alma PR Josh Royston Robyn Fisher	Tel: [phone] Tel: [phone]

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® 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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