Recognify Life Sciences to Commence Phase 2a Study in Cognitive Impairment Associated with Schizophrenia
NEW YORK, April 6, 2021 /PRNewswire/ -- Recognify Life Sciences, Inc. (Recognify), an atai Life Sciences (atai) platform company focused on developing treatments for cognitive impairment with initial efforts targeting Cognitive Impairment Associated with Schizophrenia (CIAS), today announced it has initiated a Phase 2a study for its lead compound RL-007, after receiving IND clearance from the Food and Drug Administration to commence clinical trials in the United States in this indication.
Schizophrenia is a mental health disorder primarily characterized by hallucinations, delusions, and disordered thinking. This condition effects over 21 million people globally and approximately 2.4 million people in the United States, with around 300,000 new cases being diagnosed each year in the US. Cognitive deficits are frequently present in patients diagnosed with schizophrenia, and such deficits contribute to the marked disability associated with this condition. There are presently no effective treatment options for CIAS.
The Phase 2a study is a single-arm, multiple dose design in patients who exhibit CIAS, and it evaluates the effects of the drug on safety and tolerability, electroencephalograms and cognition. This study will provide the first data sets for RL-007 in CIAS patients and enable Recognify to progress the product towards a Phase 2b efficacy study in this area of high medical need.
"In a treatment landscape with no effective options, we are determined to progress RL-007 for the treatment of CIAS. We believe that the compound has great potential in CIAS, based upon the promising pro-cognitive profile demonstrated in previous preclinical and clinical studies," said Florian Brand, CEO and co-founder of atai.
"RL-007 is a unique asset that we believe has the potential to bring significant benefit to CIAS patients. We are focused on rapidly executing a series of high-quality studies to understand the utility of the compound in CIAS and clearly demonstrate the cognitive enhancing effects in these patients," said Matt Pando, PhD, CEO and co-founder of Recognify. "This study is the first step towards bringing an effective treatment option to CIAS patients."
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