It is a pivotal time for Small Pharma, as it anticipates data from its Phase IIa trial with lead candidate SPL026 – its proprietary DMT formulation.
As Small Pharma looks towards the latter stages of drug development, it has recalibrated its leadership accordingly, appointing George Tziras CEO in July.
Tziras, previously Chief Business Officer, has over 15 years’ experience in investment banking and capital markets, holding the position of Executive Director at Goldman Sachs before joining the company.
Since the appointment, Small Pharma has seen its share price surge 100%. PSYCH spoke with the new CEO on capital markets and the commercialisation of psychedelic healthcare.
‘I’ve been at Small Pharma since the early days,’ explained Tziras. ‘I worked pretty closely with Peter Rands, the founder, advising the company from inception within the capacity of a board director, before I joined full-time – initially as Chief Business Officer in 2021. That was around the time the company was transitioning from a private company into a publicly listed company.
‘In the summer I became CEO, and at the same time we hired biotech veteran Dr Alastair Riddell as COO, to further expand the executive team as we get ready for later-stage clinical trials and think about our plans for commercialisation.
‘Our development programmes are the primary focus right now, with proof of concept for SPL026 in a Phase IIa trial. We are also progressing our R&D efforts across our development pipeline, and preparing for Phase IIb.
‘That is not to say we aren’t being proactive on the commercialisation front. We recognise that planning for what is needed for the in-clinic delivery of these treatments is important, should they come to market.
‘There are a number of additional considerations that need to be thought about for the roll-out and we’ve already initiated market research, so we have insight into the positions of patients, physicians and, importantly, payers.
‘This is so we can better understand how these potential treatments are perceived, which helps build out our commercialisation strategy. As we progress into the later stages of clinical trials, it will help further establish realistic expectations of the anticipated treatment journey. Additional services may need to be set up to offer better support to patients.’
The ancillary support services needed to maximise psychedelic healthcare will be essential, yet are rarely discussed. PSYCH asked the Small Pharma CEO if he knew when the company would have visibility into the makeup of these solutions.
‘We are learning as an industry,’ said Tziras. ‘As psychedelic therapies progress towards approval, many of these aspects are being better articulated. The programmes approved first will be the trailblazers in some ways, and we’ll adapt our programmes accordingly. For us, it is becoming much more of a focus as we roll into the latter stages of clinical development and look ahead to Phase IIb and beyond.’
Last month, Small Pharma announced it had finished recruitment for its Phase IIa clinical trial with SPL026. The company is studying the intravenous formulation’s efficacy to treat major depressive disorder, when administered with supportive therapy.
‘Our lead programme, SPL026, is currently nearing the conclusion of its Phase IIa trial with supportive therapy for the treatment of major depressive disorder. As far as we are aware, it is the most advanced DMT programme for depression in commercial development.
‘For SPL026 we were granted the MHRA’s Innovation Passport designation, as part of ILAP, the Innovative Licensing and Access Pathway, which expedites innovative treatments through the regulatory process. In terms of timing, our last patient was dosed in September and patients are followed up for 12 weeks as part of the trial’s design – so we expect data to be available shortly after.’
The results of these trials present a potential inflection point for Small Pharma. In August, the company reported a cash position of C$27.1 million – with cash used in operating activities of C$6 million for Q2. PSYCH was eager to ask Tziras if this was sufficient to see SPL026 through Phase III trials and into commercialisation, having led Small Pharma’s C$63 million raise in 2021.
‘It’s pretty fair to say a typical clinical development programme costs hundreds of millions of dollars to reach market approval,’ acknowledged Tziras. ‘Relative to the development programmes at larger pharmaceutical companies, our operations are much leaner and we are working with a known compound, which in principle should allow for a more cost-efficient development programme.
‘Late-stage trials are more expensive to run, predominantly because they are larger and often run across multiple jurisdictions. Right now we are well funded to progress with our plans. As we move into the later stages, we anticipate requiring additional capital to advance these programmes. As and when appropriate we will consider all the options available and what is in the best interest of the company.’
Looking ahead to the future, PSYCH asked Tziras about the potential adoption of SPL026 and its application in psychiatry.
‘We have good reason to believe, based on the research that exists today, that DMT could have a similar therapeutic potential to other psychedelic drugs,’ said Tziras.
‘At Small Pharma we are optimising for the potential scalability of the treatment, and believe its short duration should help us maximise patient reach, which is a critical consideration due to the magnitude of the mental health crisis.
‘Based on our Phase I data, SPL026 offers a 20-to-30-minute psychedelic experience. With the wraparound supportive therapy, that could result in an in-clinic treatment time between two hours and two and a half hours.
‘We selected candidates we believed we could deliver a strong IP strategy around, so that we could protect and support our innovation. In this regard we have made good progress in 2022, increasing our number of patents three-fold – from four at the start of the year to 12 to date.’