Short-acting psychedelics company Small Pharma Inc. DMTTF has received the approval from the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) and the Regional Ethics Committee for a drug interaction clinical trial to take place on national grounds.
The novel study will assess the interaction between Serotonin Reuptake Inhibitors (SSRIs) and SPL026, Small Pharma’s proprietary DMT lead candidate, for patients with Major Depressive Disorder (MDD). It is set to begin in the third quarter of 2022, and dosing completion is anticipated for the first half of 2023.
The trial holds a particular importance, as positive results could broaden patient reach to those who are currently taking SSRI. Precisely, it aims at understanding the impact of SSRIs on the safety, tolerability, PK and PD of SPL026 together with psychotherapy, in up to 24 patients.
These endpoints will then be assessed in patients suffering from MDD, who are currently getting SSRI treatment that proves ineffective in fully relieving their depression, compared with patients not taking SSRIs.
Small Pharma’s chief medical and scientific officer Dr. Carol Routledge further explained: “In the Phase I/IIa SPL026 clinical trial currently underway, patients must be withdrawn from existing antidepressant medication, which can be disruptive and unsettling for some. This may not always be in the best interest of patients, even if the medication is ineffective.”
That’s where the new trial comes in, as encouraging results from the present study “could facilitate patient recruitment in future clinical trials as patients may no longer be required to discontinue their SSRI medication,” and most importantly, in the long run, “successful results could open up the potential to broaden patient accessibility to DMT-assisted psychotherapy.”
CEO George Tziras reaffirmed the company’s priorities and decisions: “Patient access is a core element of Small Pharma’s values and strategy, which is reflected in our approach to research and development. As we progress through our clinical programs, it’s key that we are agile and most importantly patient-led.”
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