Psyence Biomedical, an associate of Psyence Group, has announced the expansion of its Phase IIb clinical trial investigating psilocybin-based treatments for Adjustment Disorder in palliative care. The addition of Empax Center in Australia as a second trial site marks a crucial advancement in the study, with patient treatments anticipated to begin soon. The first subject is expected to be enrolled in early December.
The Phase IIb trial is designed to evaluate the efficacy and safety of psilocybin-assisted therapy in patients experiencing Adjustment Disorder within a palliative care context. Adjustment Disorder is a prevalent condition characterized by emotional and behavioral symptoms arising in response to identifiable stressors, such as a serious illness diagnosis. In palliative care, where patients face significant emotional and existential challenges, effective treatments for Adjustment Disorder are critically needed.
"The expansion of our clinical trial to include Empax Center in Australia underscores our commitment to rigorously investigating the potential of psilocybin to address unmet needs in mental healthcare," stated a representative from Psyence Biomedical. "We are eager to begin patient treatments and gather data that will inform future registrational studies."
The company anticipates announcing topline data from the Phase IIb trial in the second half of 2025. Positive results could lead to pivotal registrational studies, potentially accelerating the development and regulatory approval of psilocybin-based therapies for Adjustment Disorder. The trial's primary endpoint focuses on measuring the reduction in Adjustment Disorder symptoms, while secondary endpoints assess improvements in mood, anxiety, and overall quality of life.
Psilocybin, a naturally occurring psychedelic compound, has shown promise in preclinical and clinical studies for various mental health conditions, including depression, anxiety, and PTSD. Its mechanism of action is believed to involve modulation of serotonin receptors in the brain, leading to altered perception, mood, and cognition. When administered in a controlled clinical setting with psychological support, psilocybin-assisted therapy has the potential to facilitate emotional processing and promote psychological well-being.
