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news.The US Food and Drug Administration (FDA) has awarded Fast Track designation to Alto Neuroscience’s ALTO-101, a novel small molecule phosphodiesterase-4 (PDE4) inhibitor for the treatment of cognitive impairment linked to schizophrenia (CIAS).
ALTO-101 is a small molecule that acts as a phosphodiesterase-4 (PDE4) inhibitor. Credit: CDC on Unsplash.
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Currently, there are no approved treatments for CIAS, a key feature of the condition that significantly affects daily functioning and the quality of life for individuals living with schizophrenia.
The Fast Track designation accelerates the development and review process for drugs that address serious conditions with unmet medical needs.
Drugs granted this designation may be eligible for more frequent meetings with the FDA to discuss their development plans, as well as for accelerated approval and priority review, provided that the relevant criteria are satisfied.
Alto Neuroscience founder and CEO Amit Etkin said: “Receiving Fast Track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia.
“This designation is a significant milestone for the ALTO-101 programme and we believe it is a testament to its potential as a novel treatment approach. Our Phase 1 data, which demonstrated significant and clinically relevant effects of ALTO-101 on both EEG measures and cognitive performance in healthy subjects, provides strong validation for its mechanism.
“We are committed to advancing this programme expeditiously for the millions of patients who currently have no approved treatment options to address these debilitating cognitive deficits.”
The PDE4 enzyme is responsible for the breakdown of cyclic adenosine monophosphate (cAMP), a molecule that plays a vital role in neuronal signalling and synaptic plasticity, which are essential for learning and memory.
By inhibiting PDE4, ALTO-101 raises cAMP levels, which is thought to enhance neural circuits and improve cognitive function, addressing issues related to impaired attention, memory, and executive function in individuals with schizophrenia.
