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Spiral Therapeutics receives positive IND submission guidance from FDA
Spiral Therapeutics, a CataloniaBio member, had reported positive feedback from the US Food and Drug Administration (FDA) in response to Spiral's first pre-Investigational New Drug (pre-IND) package submission.
The FDA provided informative feedback on important product development questions related to manufacturing and non-clinical testing and concurred with Spiral's clinical development plans for its LPT99 program for the prevention of chemotherapy-induced hearing loss in pediatric patients. The LPT99 is a first-in-class drug candidate.
"We are pleased with the feedback received from the FDA, which is consistent with our expectations and our plans to initiate clinical trials with LPT99," said Hugo Peris, founder and CEO of Spiral Therapeutics. "Given the strong signs of safety and efficacy of LPT99, we have decided to focus our efforts on the development of our lead candidate and to explore its use for other inner ear indications beyond chemotherapy-induced hearing loss."
Following the positive news, Spiral plans to raise additional proceeds to fund an initial Phase 1 trial, the development of new preclinical data and the company's operations for the next 18 months.
Spiral Therapeutics is an American biopharmaceutical created by the Catalan Hugo Peris. Spiral head-courters are in San Francisco but its R & D & I department is in Barcelona. Peris is also a non-executive member of the Laboratorios Salvat board.
More information is available on the Spiral Therapeutics website.
Foto: Hugo Peris, CEO of Spiral Therapeutics © Spiral Therapeutics