Approval for Small Pharma major depressive disorder clinical trial

Approval for Small Pharma major depressive disorder clinical trials

Small Pharma Inc. has received approval from the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) and the Regional Ethics Committee to initiate a drug interaction clinical trial in the U.K. 

The clinical trial will assess the interaction between serotonin reuptake inhibitors (SSRIs) and SPL026, the company’s lead N, N-dimethyltryptamine (DMT) candidate, in patients with major depressive disorder (MDD).

DMT is a naturally-occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (less than 30 minutes), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.

MDD clinical trial details

This study is being conducted at two MAC Clinical Research sites and will assess the impact of SSRIs on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy in up to 24 patients. 

These endpoints will be assessed in patients with MDD who are currently on a treatment course of a SSRI that is ineffective in fully relieving their depression, compared with patients not currently on a prescribed SSRI. The trial is expected to begin in Q3 2022, with dosing completion anticipated in H1 2023.

Carol Routledge, chief medical and scientific officer, said: “In the phase I/IIa SPL026 clinical trial currently under way, patients must be withdrawn from existing antidepressant medication, which can be disruptive and unsettling for some.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.

“Encouraging results from this study could facilitate patient recruitment in future clinical trials as patients may no longer be required to discontinue their SSRI medication. In the longer term, successful results could open up the potential to broaden patient accessibility to DMT-assisted psychotherapy.” 

George Tziras, CEO, added: “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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