Fresh Off a $110 Million Series C, Praxis Precision Medicines Eyes $190 Million IPO
This morning, the company, which was formerly known as EpiPM Therapeutics, will begin trading on the Nasdaq Global Select Market under the ticker symbol PRAX. Share prices are expected to open at $19. Praxis is well-positioned financially to use its precision medicine approach to developing therapies for central nervous system (CNS) disorders characterized by neuronal imbalance. The company officially launched in May with $100 million in financing supported by Blackstone Life Sciences and Novo Holdings.
Proceeds from the stock sale will support the development of its mid-stage asset under development as a treatment for major depressive disorder (MDD), as well a Phase I program for pediatric epilepsy and a Phase I program for adult cephalgia, or cluster headaches. In its IPO prospectus, Praxis said it anticipates multiple topline clinical trial readouts from its three clinical-stage product candidates prior to the end of 2021. Additionally, the company expects to launch another clinical development program in 2021.
The Phase II asset PRAX-114 is an extrasynaptic-preferring GABAA receptor positive allosteric modulator. It is under development as a potentially differentiated treatment as both a monotherapy and adjunctive therapy for both the acute and maintenance setting in MDD. In the Phase IIa part of the study, the company said it observed marked improvements in depression scores in MDD patients within two weeks of treatment. A Phase II/III study is expected to begin in the United States and Australia in the fourth quarter of 2020. Topline data from this study is expected in 2021 and will be used to one of two registrational trials required by the U.S. Food and Drug Administration for potential approval in this indication.
PRAX-944, a potentially differentiated selective small molecule inhibitor of T-type calcium channels, is under development for the treatment of Essential Tremor. Praxis said it is conducting a Phase IIa proof-of-concept open-label trial in ET patients. Topline data, including from a high-dose cohort, is expected in 2021.
The company’s third clinical candidate PRAX-562 is a selective, persistent sodium current blocker in development for the treatment of a broad range of rare, devastating CNS disorders, such as severe pediatric epilepsy and adult cephalgia. The company initiated a Phase 1 trial of PRAX-562 in Australia to evaluate the safety, tolerability, PK and effects on an EEG biomarker in up to 129 adult healthy volunteers.
In addition to its clinical programs, Praxis Precision Medicines has one preclinical program and one disclosed discovery program in development for severe genetic epilepsies. Praxis anticipates submitting an Investigational New Drug application for one of these programs in the second half of 2021.