atai Life Sciences Announces Supportive Interim Data from First 8-Patient Cohort of Phase 2a Trial for Novel Treatment of Cognitive Impairment Associated with Schizophrenia
atai Life Sciences (NASDAQ: ATAI) today announced that it has observed encouraging interim data from the first 8-patient cohort of its Phase 2a trial, demonstrating potential pro-cognitive effects of its compound RL-007, a cholinergic, glutamatergic, and GABA type B receptor modulator, for Cognitive Impairment Associated with Schizophrenia (CIAS).
These early data have led atai to commit additional financial resources, enabling an accelerated clinical development timeline for RL-007, even ahead of completion of the ongoing Phase 2a trial.
The interim Phase 2a readout reported promising assessments for the 8-patient cohort from two quantitative biomarkers, qEEG (quantitative electroencephalogram) and ERP (evoked-response potential) and indicated changes that are consistent with improved cognition. CIAS is a major unmet need for those living with schizophrenia, with no effective treatments currently available.1 Full results of the current Phase 2a trial are expected by the end of 2021.
The financial boost by atai will enable immediate initiation of planning stages for the next clinical trial, ahead of schedule and prior to the Phase 2a’s conclusion. The atai RL-007 trials are being conducted by Recognify Life Sciences, an atai Life Sciences platform company.
“With these data, from the interim analysis of the ongoing Phase 2a trial, we are encouraged to accelerate the overall development of RL-007 for CIAS,” said Matthew Pando, PhD, CEO and Co-Founder of Recognify Life Science. “I would like to express my deepest gratitude to the patient volunteers who have supported our clinical trial thus far. I believe that, with continued support, we have the potential to bring benefit to patients living with schizophrenia and its often very challenging cognitive impacts.”
We believe that, although preliminary, these promising data give us confidence to further support and expedite the clinical trajectory for RL-007 and we look forward to the full data set. “With its unique mechanism of action, we think that RL-007 has potential to address a major unmet need in terms of addressing the cognitive deficits that can be so debilitating for people with schizophrenia.Florian Brand, CEO and Co-Founder of atai Life Sciencess
Schizophrenia is a mental health disorder primarily characterized by hallucinations, delusions, and disordered thinking. This condition effects over 21 million people globally and approximately 3.5 million people in the United States.2,3
CIAS is a major unmet need for those living with schizophrenia. Cognitive deficits are frequently present in patients diagnosed with schizophrenia, and such deficits contribute to the marked disability associated with this condition, impacting the ability of patients to carry out some basic living tasks, like pursuing education and holding down a job.4
About the RL-007 Phase 2a trial
The ongoing Phase 2a trial is a single-arm, single blind, multiple dose study of oral RL-007 administered to subjects with schizophrenia who are currently stable on a protocol-allowed antipsychotic regimen. Subjects continue their antipsychotic treatment without change throughout the course of this study. All subjects receive four doses of placebo followed by six doses of RL-007, although subjects are blinded to the dose strength or sequence of active and placebo capsules.
RL-007 has a unique mechanism of action, impacting both cholinergic and gamma-aminobutyric acid type B (GABA type B) receptor systems, which are both are central to learning and memory functions. With its unique mechanism of action, we believe RL-007 may enhance pro-cognitive functioning, such as neuronal signaling, learning, and memory.
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