The FDA has slapped a clinical hold on Praxis Precision Medicines’ PRAX-222, a drug aimed at treating early-onset epilepsy and one of the biotech’s three product candidates set to enter clinical-stage development by the end of this year.
Praxis received an email communication from the FDA on April 28 ordering a clinical hold for PRAX-22, an antisense oligonucleotide for SCN2A patients with early-onset seizures, according to an April 28 regulatory filing. The FDA hold comes after Praxis filed an investigational new drug application with the agency for the treatment-seeking approval to enter a human study.
Though the reasons for the pause haven’t been released yet, Praxis expects to receive an explanation letter from the FDA within 30 days.
The day before, Praxis posted an update on three of its most advanced epilepsy programs, including PRAX-222, stating that each product was anticipated to enter clinical-stage development by the end of 2022. The other drugs include PRAX-562, which is set to move into phase 2 in groups of children with SCN2A epilepsy, SCN8A epilepsy and tuberous sclerosis complex in the second half of the year. The other leading epilepsy program is PRAX-628, with the expected initiation of a phase 1 in the fourth quarter of 2022 and a phase 2 study in focal epilepsy forecasted for 2023.
Praxis aims to translate genetic underpinnings of brain disorders into precision medicines. In 2020, the Cambridge, Massachusetts-based biotech pulled off a $190 million IPO, upgrading from the $100 million listing it initially sought.
Shares of the small biotech dropped 9% to $7.81 as of 12:28 p.m. ET, compared to $8.20 at open on Friday.