April 2023 Company Update
Earlier this year, we announced the positive top-line results from our Phase IIa trial of SPL026 in Major Depressive Disorder (MDD) – a major milestone for the business. We’re excited to share what’s been happening at Small Pharma since.
Here’s a highlight of recent news and events.
New Positive Six-Month Data from Phase IIa Trial of SPL026
Yesterday we announced further positive efficacy data from our six-month follow-up in patients with MDD, demonstrating the sustained antidepressant effect of a treatment with SPL026. Read our latest press release.
Roundtable on Short Duration Psychedelics for Depression
Our Chief Medical & Scientific Officer Dr Carol Routledge facilitated a lively roundtable with distinguished psychiatrists Jerry Rosenbaum, MD Harvard Medical School and David Erritzoe, MD, PhD Imperial College London. Here are some highlights from the discussion.
The current treatment journey for patients with Major Depressive Disorder
- Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants remain the first line treatment but only 1 in 3 patients can expect to respond to SSRIs.
- In the UK, there is a new treatment pathway that now offers early access in a patient’s treatment journey via Cognitive Behavioral Therapy (CBT) psychological support.
- One of the challenges with current treatments is the inability to match people to a treatment they will respond to.
The potential of short-duration psychedelic therapy treatments
- The combination of pharmacological medication and psychological support (novel drugs alongside therapy) is exciting.
- Clinical colleagues who are not currently working with psychedelics seem cautiously excited about their potential. There is an expectation that the psychiatry community will welcome these treatments with open arms, if the positive efficacy and safety profile continues to be demonstrated in clinical trials.
- Identifying and designing the optimal amount of therapy for each patient within a psychedelic-assisted therapy treatment will be an interesting challenge to solve in future studies.
- Both psychiatrists accept that psychedelics elicit its effects at a neurobiological level. However, data from the available studies suggest psychedelic treatment with the addition of psychological support may lead to improved outcomes.
- As episodic treatments, short-duration psychedelic therapies could be supported by digital tools. These supportive tools could be used to help signal to physicians when patients may be about to relapse, and help determine individualised retreatment protocols.
A look to the future at what it might take to bring such treatments to market for patients
- Overall, both psychiatrists are optimistic that these treatments could be important to the future delivery of mental health care but acknowledge they do not expect these treatments to be panaceas
- There was an appreciation that things have moved on from the ‘hype bubble’ around psychedelics towards acknowledging the area as a therapeutic field as demonstrated by the inclusion of psychedelic research in leading scientific conferences.
- Until recently, the world’s main experience with psychedelics has been through recreational or spiritual use. Psychedelics offered as clinical treatments for well-defined conditions is a very different proposition.
- As the industry considers the future roll-out, considerations around the requirements for training and the facilities itself such as the environment and setting, will be critical for psychiatrists, therapists and physicians to support the safe and effective application of these treatments.
You can view the replay here.
New paper from Timmermann et al shows images of the brain during a DMT experience
A recent study published by Timmermann et al. 2023 reveals insights from its neuroimaging study investigating the effects of DMT on the brain in healthy volunteers. The study provides the most advanced view to date of the effects on brain activity following administration of DMT.
These are our key takeaways from the study:
- Using a combination of brain imaging techniques – electroencephalography (EEG) and functional-magnetic resonance imaging (fMRI) – this study gives us the most comprehensive picture yet of how the brain behaves on DMT. It supports existing theories on the mechanism of action of psychedelics in the brain in terms of regional network activity and functional connectivity.
- The study shows that DMT increased communication between regions of the brain that were not functionally connected in a resting state. This is called global hyperconnectivity between brain regions.
- DMT leads to a disruption in the normal organisation of information processing. The prevailing theory of how our brains process information is via a hierarchical top-down organisation whereby higher order cognitive processing areas provide a framework for processing sensory information. Imaging data shows that a DMT experience flattens this hierarchical organisation between higher-order (i.e. association cortex) and sensory areas.
- DMT led to increased dysregulation of brain activity, as characterised by changes in brain wave activity and signal diversity. This included reductions in alpha power (decreased alpha power is usually associated with sleep and relaxed states) and increases in gamma power (increased gamma power is usually associated with enhanced sensory processing and cognitive performance)
- Regions of the brain with the most dense expression of serotonin or 5-HT2A receptors were most affected by DMT, and overlapped with disrupted brain regions under DMT.
Compression of the principal gradient under DMT:
Ellen James, Director of R&D, presents at the ECNP
Earlier this month, our Director of Research & Development, Ellen James, attended the European College of Neuropsychopharmacology (ECNP) New Frontiers: Psychedelics conference in Nice, France.
Over two days, a group of 100 carefully selected scientists, researchers, regulators and patient advocates explored a range of topics about the past, present and future of psychedelics research and their potential application as clinical treatments.
Ellen said:
This was a fantastic opportunity to connect with other industry and research leaders to discuss the development of psychedelics as a new treatment for brain disorders, like depression. Sessions covered important topics such as regulatory considerations, preclinical and clinical research, and patient perspectives. I want to thank the ECNP for organising such an inspiring, focused and informative conference”
