Our year in review
As 2023 draws to a close, it seems right to look back on the tremendous progress that we at OCT have made over the last 12 months, which have seen significant and cumulative achievements by our business. During the year, we successfully entered our lead programme into the clinic; announced the results of our first Phase I single ascending dose clinical trial; appointed a new General Counsel and new Chief Medical Officer; and strengthened our advisory team with expert appointments.
At the start of the year, we submitted a combined clinical trials application for our lead programme, OCT461201, to the UK Medicines & Healthcare products Regulatory Agency (MHRA) and Wales Research Ethics Committee 2 (REC 2), following an extensive programme of pre-clinical work. This was a watershed moment for our business as we took the momentous step from being a pre-clinical stage biotech to a clinical stage one. More about the consequences of that, shortly.
We also strengthened our leadership team with the appointment of Rob Bennett as General Counsel and Company Secretary. Rob brought with him over 15 years of UK and international experience across a diverse range of complementary sectors and, in the time that has since elapsed, has already proven himself to be an invaluable addition to our team, offering expert advice on issues of governance and law, while also bringing with him fresh impetus and valuable experience to our core team.
In April, I was honoured to be asked by our Board to step up from interim CEO to become the permanent CEO of OCT, grateful for the privilege to serve and proud to be standard bearer for the exciting and important work that lies ahead for our company.
Around this time, we were pleased to receive confirmation of the renewal of our vital Home Office licence, which allows us to possess and supply Schedule 1 drugs, and enables us to continue our pivotal research work with cannabis as we seek to harness the therapeutic power of cannabinoids to help those living with debilitating conditions.
In May, we began to reap the benefits of our diligent pre-clinical work, conducted back in 2021 and 2022, on OCT461201 as we received approval from the MHRA and REC 2 to commence the combined Phase I clinical trial for our lead drug candidate. Our Phase I clinical trial aimed to demonstrate the safety and tolerability of the drug as we seek to develop an effective therapy for chemotherapy induced peripheral neuropathy (CIPN), a debilitating condition which manifests itself as pain, numbness and tingling in the extremities. I continue to be proud of the speed with which we guided OCT461201 into the clinic, just 23 months after our listing on the London Stock Exchange, and we remain excited about the prospects of programme 1 as we move OCT461201 to the next stages of its development.
Reflecting our ground-breaking transition into a clinical stage company, we created the position of Chief Medical Officer (CMO) and were fortunate enough to be able to persuade Dr Tim Corn, with his impressive track-record as CMO at Jazz Pharmaceuticals, EUSA Pharma Inc and Zeneus Pharma Ltd, to fulfil this important role. With the experience of succeeding in over 20 regulatory approvals in the US and Europe, Dr Corn is an important asset to the company as he directs the clinical side of our operations and leads our clinical development strategy.
In July, we were delighted to report another exciting announcement with our expansion into oncology when our talented and hard-working team identified a potential first in class immunotherapy agent for the treatment of solid tumours. Initial data from our programme 4 drug candidate demonstrated excellent drug-like potential for a cannabinoid-based medicine that could be taken at home as a tablet, providing a viable alternative to expensive biologics. We remain excited about the potential of this programme.
A short time later, we were pleased to announce the successful administration of the first-in-human dose of our lead pharmaceutical drug compound, OCT461201, as part of our Phase I clinical trial seeking a therapy for CIPN. To support our development in this area, we also appointed Dr William Paul Farquhar-Smith, an expert in CIPN from The Royal Marsden NHS Foundation Trust, as an external adviser, to support our quest for a clinically-approved treatment for this debilitating condition.
In October, the process that had begun with our application to MHRA and REC 2 in January 2023 reached its first major milestone, with the release of the results from the Phase I single ascending dose study of OCT461201. The results demonstrated that no safety or tolerability concerns were exhibited with any dose tested, conclusively satisfying our team that it was safe to proceed to the next stage of clinical development. To reach this point, fewer than 30 months since flotation, was an immense demonstration of the diligence and expertise of our talented team and we look forward to moving the programme forward.
Last month, we were delighted to welcome Dr Tim Corn, our CMO, to our Board in the role of executive director. In a short space of time, Tim has made an outstanding contribution to OCT and, accordingly, the Board has thought it right that his strategic insights should be more fully at the disposal of the Board, to augment and reinforce Tim’s continued role and expertise as our CMO.
As you will be able to see, this has been an extraordinarily action-packed year for OCT – and one brimming with energetic activity and achievement.
As we approach the festive season, I am delighted to have this opportunity to put on the record my thanks to our brilliant and hard-working team and partners for the progress OCT continues to make. In particular, we thank Askat Inc, Evotec, and Simbec Orion who have each played their part in the successful completion of our first ever clinical trial.
And to all our shareholders, stakeholders and online followers, we thank you for your support and encouragement. On behalf of everyone at OCT, have a very happy and healthy Christmas!
Clarissa Sowemimo-Coker, Chief Executive Officer of OCT