Alto Neuroscience Soars 56% on FDA Fast Track for Schizophrenia Drug
Regulators expedite review for ALTO-101, a novel treatment for cognitive impairment in schizophrenia, a condition with no currently approved therapies.
Shares of Alto Neuroscience (ANRO) skyrocketed over 56% after the company announced a significant regulatory milestone. The U.S. Food and Drug Administration (FDA) has , aimed at treating cognitive impairment associated with schizophrenia (CIAS).
The designation underscores the urgent need for new treatments in this area, as there are currently no FDA-approved drugs specifically for CIAS. This condition affects millions and impairs daily functions such as memory, attention, and decision-making. The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need, potentially leading to earlier patient access.
"The FDA's decision to grant Fast Track designation to ALTO-101 acknowledges the immense unmet need for treatments that can address the cognitive deficits experienced by people living with schizophrenia," said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience, in a company statement. The expedited pathway allows for more frequent meetings with the FDA and eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
ALTO-101 is a novel phosphodiesterase-4 (PDE4) inhibitor that works to increase cyclic AMP (cAMP) levels in the brain, which are crucial for synaptic plasticity, learning, and memory. The reflects investor optimism about the drug's potential and the de-risking effect of the FDA's designation.
Alto Neuroscience is currently conducting a Phase 2 proof-of-concept study of ALTO-101 in patients with CIAS. The company utilizes a precision psychiatry approach, using brain-based biomarkers to identify patients who are most likely to respond to its treatments. This method aims to increase the probability of clinical success and tailor therapies to individual patient needs. With the Fast Track designation, Alto is positioned to advance ALTO-101 through clinical development more rapidly, offering new hope for patients and signaling significant potential for investors.