Andrew McClean: Who founded Healome Therapeutics?
Richard Williams: The company was founded by me, Professor Liam Grover, Professor Tony Metcalfe, and Dr Richard Moakes while we were at the Healthcare Technologies Institute (HTI), University of Birmingham. I moved over to the company to take up the CEO position.
AM: Why was the company established?
RW: The founders’ ambition has been to develop technologies that enable people to live healthier and more independent lives. While we were at the Healthcare Technologies Institute, University of Birmingham, we developed technologies for delivering therapeutics around the body and the ability to manufacture them to clinical grade. This was an ideal environment to support some of the riskiest development stages from a private sector perspective. However, onward delivery to market at scale requires substantial capital feeding into an organisation focused on the vision, hence, Healome Therapeutics was formed.
AM: What are Healome’s aims in the dry eye market?
RW: We envisage patients being able to manage their condition around their daily lives. We aim to create products offering more effective and longer lasting relief that address drivers of the condition and that are practical to use. The cost, real-world efficacy and market toleration of pricing of cutting-edge therapies is a constantly running debate. We see opportunities to co-develop novel products that make the most effective use of each ‘unit’ of therapeutic and catalyse their adoption in the long run. Dry eye is on the rise globally and a broader aim for us is to enable healthcare systems to meet eye health challenges in the long run and consider access to treatments across the entire care pathway.
AM: How does the gel treat patients living with dry eye disease?
RW: Our formulations flow like a liquid when extruded from a dropper over the ocular surface and restructure into a clear thin protective layer. This layer liquefies and restructures during blinking and is cleared away by blinking over a prolonged period time. The formulations are preservative-free and provide lubrication, physical protection, and delivery and retention of drugs on the ocular surface for several hours at a time. We hope that patients will find it easier to read, travel, operate in dry or air-conditioned environments, or even sleep. Incorporating medicines to treat the underlying biology may enable long-term stabilisation or improvement of dry eye disease.
AM: How does it differ from other available treatments?
RW: This depends on what types of dry eye products we are comparing. Current lubricants have handling properties ranging from water-like, through to gels and oils and onwards to thick paraffin-based products. Data suggests our formulations can have a residence time and protection similar to thicker lubricants, yet have the comfort of a very low-viscosity lubricant. We can also tune the mechanical response to the use scenario. From a pharmaceutical perspective, the technology combines some of the drug retention benefits of drug loaded contact lenses with the relative ease of applying an eyedrop.
AM: What research was carried out on dry eye during the development of Healome’s gel?
RW: The technology was created from significant expertise in structuring bio-materials in ways that make them clinically useful in delivering therapeutics. Close engagement with clinicians and patients starting from the early stages of development at the university has been essential. The Healthcare Technologies Institute has a long-established collaboration with professor Saaeha Rauz, an internationally acknowledged ophthalmologist, who runs a specialist tertiary referral service for complex ocular surface diseases at the Birmingham & Midland Eye Centre.
Professor Rauz’s patients and research team are based at the University of Birmingham and have been instrumental in providing a wealth of understanding of the complexity of dry eye disease, how it impacts patients’ wellbeing and the need for innovation. This subsequently led to several prestigious academic funding awards (MRC and NIHR i4i PDA) to take the technology through phase 1 clinical trials (shortly to open during the winter), pushing the technology further along the translational pathway.
AM: What are the key findings from studies that have been completed so far?
RW: Healome’s technology has an excellent pre-clinical safety profile with no local or systemic toxicity issues. We can incorporate and maintain activity of a growing range of therapeutics, including antibiotics, anti-inflammatories, enzymes, blood components, recombinant proteins and even cells. A pilot pre-clinical efficacy study of a biologic anti-scarring drug combined with our eyedrop technology showed almost complete regeneration of corneal microbial keratitis wounds within 14 days.
AM: When is it likely to be available?
RW: Two phase 1 trials will be running in 2023, one of which involves patients with moderate to severe dry eye stemming from a range of underlying medical conditions. This trial involves our eyedrop technology combined with an allogenic serum, which supports ocular surface health. We are exploring several other clinical conditions of urgent need and await regulatory updates on accelerated pathways to those patients.
AM: What are the next steps for Healome?
RW: Next steps are to continue discussions with the industry and to achieve Good Manufacturing Practice standards. This will feed into our plans to raise another round of investment in 2023.