N4 Pharma Plc Regulatory News (N4P)

30 June 2017

N4 Pharma Plc

("N4 Pharma" or the "Company")

Update on toxicity testing of nuvec® particles

N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, is pleased to announce the latest research results for its nuvec® nanoparticles which it is developing as a delivery system for DNA and mRNA vaccines and therapeutics.

Toxicity Study Results

The objective of this study (funded via a biomedical Catalyst grant) was to assess the systemic tolerability of the nuvec® Silica nanoparticles when administered as a single dose via subcutaneous injection to rats, a standard non-clinical species for such studies.

Animals were dosed once with 50, 150, 400 or 900 mg/kg nanoparticles, and then observed for 14 days. Clinical observations, body weights and food consumption were recorded, blood plasma samples were analysed for clinical pathology and selected common target organs were examined microscopically.

The nanoparticles did not cause any systemic toxicity and all organs examined microscopically were normal, including at the highest dose, which is likely to be many times in excess of the concentrations that might be administered to humans. While there was some mild to moderate inflammation observed at the injection sites at all doses, these were non-specific and generally indicative of local inflammation. 

According to the board certified pathologist used in the study, these were similar to that which would be expected following implantation of a medical device or as a result of injecting a vaccine and would almost certainly resolve over time.

In conclusion, a single subcutaneous administration of the nuvec® nanoparticles to rats did not cause any toxicological effects considered likely to be of long term concern.

ApconiX Limited, the Company's partners in these studies, have approved this as an accurate reflection of the results observed.

Following these results, further in vivo studies to demonstrate the transfection capability of the Company's nuvec® particles will be performed.

Nigel Theobald, CEO of N4 Pharma, commented:

"We continue to make good progress demonstrating the capability of our nuvec® vaccine delivery system.

We have already demonstrated its transfection capability compared to standard industry in vitro techniques (lipofectamine) and it is important we undertake studies to further show we can achieve transfection in an in vivo environment. Whilst there remain several important steps before we can demonstrate the suitability of our nuvec® system to our potential commercial partners, the fact that we can show there is no systemic toxicity is a very important hurdle to overcome.

 We will provide further updates as each step of the program develops."

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About N4 Pharma

N4 Pharma was formed in 2014 by Nigel Theobald, the former Chief Executive of AIM quoted Oxford Pharmascience Group plc. It 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

• delivery of novel and existing vaccines.

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 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.

About ApconiX

ApconiX is a specialist pre-clinical toxicology consultancy based in Biohub at Alderley Park