Praxis Precision Medicines’ PRAX-222, an early-onset epilepsy drug and one of three candidates for biotech products expected to enter clinical development later this year, has been clinically suspended by the FDA.
Praxis received an email from the FDA on April 28 ordering a clinical block for PRAX-22, an antisense oligonucleotide for SCN2A patients with early seizures, according to an April 28 regulatory filing. The FDA’s position comes after Praxis filed a new drug investigation application with the agency to seek approval for the treatment to enter a human trial.
Although the reasons for the rupture have not yet been disclosed, Praxis expects to receive an explanatory letter from the FDA within 30 days.
The day before, Praxis had released an update on three of its major epilepsy programs, including PRAX-222, stating that all products are expected to enter clinical development by the end of 2022. Among other drugs, PRAX -562 is expected to enter clinical development. phase. 2 in groups of children with SCN2A epilepsy, SCN8A epilepsy, and complex tuberculous sclerosis in the second half of the year. The next major epilepsy program is PRAX-628 and is expected to begin a Phase 1 study in the fourth quarter of 2022 and a Phase 2 focal epilepsy study is proposed for 2023.
Praxis aims to shift the genetic basis of brain disease into precision medicine. In 2020, Cambridge-Massachusetts-based biotechnology completed an IPO of $ 190 million, surpassing its original listing target of $ 100 million.
Small biotech stocks fell 9% to $ 7.81 at 12:28 pm. ET, down from $ 8.20 opening on Friday.