Doug Hartley

What does your role of Chief Medical Officer entail?

As the Chief Medical Officer for Rinri Therapeutics, I’m responsible for the clinical strategy: taking Rincell-1 towards the first-in-human trial of a stem cell or cell-based therapy for hearing loss. We’re so excited! We’re due to start trials in 2024 but we have a lot of work to achieve before then. Back in October 2022, we hired Rachel Haines as our Director of Clinical Operations. Rachel and I have worked together before on hearing-related trials at Nottingham University, and she previously worked as a Senior Trials Manager at the Nottingham Clinical Trials Unit. We know that we work well together and we are excited to apply this to the team and to take the Rincell-1 treatment forwards. The trials will aim to demonstrate the safety of Rincell-1 and we are keen to show any early signs of its effectiveness. This is a brand-new treatment for a brand-new treatment area. While I am a cochlear implant surgeon in my other role, patients are looking for a biological solution for hearing loss. Cochlear implants can’t give them back natural hearing, so it’s really exciting to work on something that could potentially revolutionise how we treat hearing loss.

How did you get into the hearing loss field? And what led you to Rinri?

I’ve always been interested in hearing loss ever since I got taught about cochlear implants whilst studying Medicine at Newcastle University. I received a Fellowship from the Royal College of Surgeons (FRCS) in Otorhinolaryngology before obtaining a Doctor of Philosophy from the University of Oxford in Auditory Neuroscience. I soon became a cochlear implant surgeon at Nottingham University Hospital, which has one of the biggest cochlear implant centres in the UK.

I learnt about Marcelo Rivolta’s ground-breaking work in cell-based therapy and restoring hearing to the animal model of auditory neuropathy about 10 or so years ago. Through my work leading the Objective Measures Group at the Biomedical Research Centre in Nottingham, I worked closely with Marcelo and his team in a university capacity. And we’ve been working closely with him and the team to do some of the underpinning work towards developing the right measurements for outcomes that are necessary for this cell-based therapy, and trying to develop the right surgical approaches to the parts of the inner ear that have never been reached before, that are vital for this therapy to work. I did this work in my university role at Nottingham in collaboration with, and funded by, Rinri. Through this, I was offered the role as Rinri’s Chief Medical Officer, which I took up in May 2022. It’s been fantastic to work with the team ever since!

What do you see as the biggest challenge for Rinri in hearing loss?

There are a number of challenges. From a hearing perspective, we have traditionally treated hearing loss with hearing devices such as hearing aids or cochlear implants. The hearing loss field has not seen many clinical trials and as Rinri Therapeutics is developing a novel therapy to treat hearing loss, it’s important for us to get it right. We are working with healthcare professionals, patients, scientists and regulators to identify challenges and barriers towards getting our therapy into the first human at the earliest stage.

It’s particularly important to be involving patients at the earliest stage possible to find out how they feel about the therapy and what they feel is important in order to design the right clinical trials. If it’s not right for patients, we can’t move forwards. This, however, has to be done in parallel with surgeons, audiologists and professional colleagues within the hearing loss team to ensure that we create the right trial design that can be implemented for Rincell-1.

While there are challenges, we’ve received some very positive and early help from external stakeholders to ensure that we can deliver.

What can you tell us about Rinri’s clinical trials pipeline?

We’re currently fleshing out the finer details of the first in-human trial, which will be our pilot trial assessing feasibility. Rinri will announce details of the trial when the time is right.

In the meantime, we’ve been working with patients to make baseline measurements themselves. We initially started this with a group of patients who have had cochlear implants for a long time and are accustomed to them. This study was conducted throughout the COVID-19 pandemic and patients were trained online to use some of the ground-breaking technologies that Advanced Bionics developed. Originally this was established for an inter operative measure, but we repurposed the technology for patients to make daily measurements of their cochlear health themselves, at home, via their cochlear implants. They were able to do this without any problems and it was the first time that’s ever been done. We subsequently extended the study to a group of patients that have only just received a cochlear implant – immediately postoperative.

With the extension of this study where we are going to extend those recordings from the three months we originally envisaged out to 12 months, creating a historic baseline control for the Rincell-1 trial.

How do you see Rincell-1 changing the hearing loss landscape?

Hearing loss has always been devasting. If we go back to Beethoven’s era, his description of the impact that his hearing loss experience had is heart-wrenching to read. A man that was able to create such amazing music and symphonies, which gave people such pleasure from an auditory perspective, then being unable to hear birdsong or the voices of his loved ones. In those days, there was little or nothing that could be done. With the turn of the 20th century, the first hearing aids started to appear. They certainly didn’t change what was going on in terms of the causes of the hearing loss, but they amplified sound. Then came the advent of the cochlear implant. A good 30 years ago, this was really starting to become a treatment and worked by by-passing the whole problem of hair cells not being able to convert the sound energy into nerve impulses. Instead, the cochlear implant electrically stimulated the nerves. This was a great advance, but it doesn’t restore natural hearing and has plateaued in its capability. The potential of Rincell-1 could be that step change in terms of treatment that patients are really looking for. One which would restore natural hearing.