Nanoengineered microneedle arrays for enhanced delivery of long-acting HIV medicines

HIV/AIDS remains a major public health threat, with approximately 36.7 million people worldwide infected. In 2016, HIV-related diseases claimed almost 1 million lives globally, with 1.8 million people being newly infected that same year. Around 20.9 million people were accessing antiretroviral therapy in 2017, constituting ~54% of adults and ~43% of children infected with the virus. . In 2016, 42% of diagnoses happened at a late stage of infection and awareness and knowledge around HIV is dropping in the UK, emphasising the value of preventative treatments. Current methods of delivering medicines for treatment and prevention of HIV are far from optimal, necessitating multiple daily tablets or painful monthly injections.

In this project we will design and test a novel type of transdermal patch that has hundreds of tiny projections on its surface. Upon painless skin application, these "microneedles" will dissolve and leave behind microscopic particles of medicine for treatment or prevention of HIV. These particles will dissolve over weeks or months to deliver therapeutic doses of the medicine. We will use state-of-the art expertise, including high power computational models to design and predict the behaviour of the medicine particles, speeding up product design and informing laboratory experiments.

The technology developed here is unique and could potentially revolutionise prevention and treatment of HIV infection. It offers the opportunity for dramatically improved treatment, with potential benefits for both patients and the NHS. Ultimately, commercialisation of the technology will be the primary route by which UK industry, the NHS and patients will derive benefits. In order to attract potential industrial or venture-funding partners, it is vitally important to demonstrate proof of concept for this technology, which is the over-arching aim of the present proposal.

Who will benefit from this research?
HIV/AIDS remains a major public health threat, with approximately 36.7 million people worldwide estimated to be infected. Several factors contribute to heterogeneity in the response to antiretroviral drugs, such as viral characteristics, immunological status and pharmacokinetic variability. Currently available formulations necessitate lifelong, daily dosing and suboptimal adherence results in low and variable exposure, exacerbating risk of failure in treatment and pre-exposure prophylaxis (PreP) The approach we propose here offers the opportunity for dramatically improved treatment and PreP. We will investigate a novel platform technology that will produce a sophisticated and distinctive minimally-invasive therapeutic system for treatment and PreP of HIV. This will benefit patients, the NHS and the UK pharmaceutical industry.

How will they benefit from this research?
In answering both fundamental and applied questions, this project will contribute to the UK knowledge base and economic development. This technology is likely to be of great interest to UK companies in the pharmaceuticals and medical devices sectors. The global market for pharmaceuticals is worth $980 billion per annum, with the global HIV drugs market set to reach $17.3 billion by 2020. Both markets are currently US-led. Due to its considerable scope for exploitation, the technology described here has the potential to make a significant and far-reaching impact in this field and place UK Research at the very forefront of developments, in accordance with the Government's Industrial Strategy.

Ultimately, commercialisation of the technology will be the primary route by which UK industry, the NHS and patients will derive benefits. In order to attract potential industrial or venture-funding partners, it is vitally important to demonstrate proof of concept, which is our over-arching aim. Considering the necessity to engage with potential marketing partners, contract negotiations and out-licensing, followed by industrial scale-up, validation of GMP manufacture and clinical trials, it is likely to be at least 5 years following completion of this project before economic and patient benefit begin to be realised.

The PDRAs and PhD student engaged on the project will have a unique opportunity to work at the interface of the pharmacological and chemical sciences and pharmaceutical engineering, to carry out research in a challenging environment and to receive both subject-specific and generic skills training. This will undoubtedly aid their personal and professional development and, in turn, their ultimate employability.

What will be done to ensure that they benefit from this research?
Allowing for IP considerations, academic publications, both journal articles and conference presentations, are likely to attract the interest of relevant industry. However, we will also make contact with the relevant UK industry players directly. The applicants have extensive experience in collaborative research with industry and the exploitation of University research. Two potential routes to market exist for this technology. The first option is out-licensing to one or more pharmaceutical/medical devices companies on a royalty basis. The second option is to form a University spin-out company with help from our universities'' technology transfer/commercialisation offices. Indeed, QUB is currently ranked 1st in the UK in the revenues of spin-out companies (survey published jointly by DTI and HEFCE), with UoL also very successful in this area.