PRAX-944 demonstrated clinically meaningful functional improvement in essential tremor patients in Part B of Phase 2a study
PRAX-114 Phase 2/3 monotherapy MDD Aria Study completed; topline results expected in June 2022
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BOSTON, May 09, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided a corporate update, including a video highlighting recent business and pipeline progress, and reported financial results for the first quarter 2022.
“This is an incredibly exciting time at Praxis, with recent events bringing us closer to our long-term vision,” said Marcio Souza, president and chief executive officer of Praxis. “With positive topline results from our PRAX-944 Phase 2a study in essential tremor, and plans to accelerate development in the ongoing Essential1 study, we will soon have a second late-stage clinical asset along with a deep and innovative early-stage pipeline. We also recently completed our PRAX-114 Aria study, with last patient last visit achieved, and look forward to sharing those topline results in June.”
Recent Business Highlights and Upcoming Milestones:
Psychiatry
- Following the completion of the PRAX-114 Phase 2/3, placebo-controlled Aria Study for monotherapy treatment of Major Depressive Disorder (MDD), Praxis expects to report topline results in June 2022. The Aria Study is intended to serve as one of two trials required by the U.S. Food and Drug Administration (FDA) to demonstrate clinical efficacy to support registration of PRAX-114 for monotherapy treatment of MDD. Following topline results from the Aria Study, the Company intends to engage with the FDA for an end-of-Phase 2 meeting and subsequently initiate a Phase 3, placebo-controlled study in the fourth quarter of 2022.
- The Company anticipates topline results from the PRAX-114 Phase 2, placebo-controlled, dose-ranging Acapella Study for treatment of MDD in the third quarter of 2022. The Acapella Study is intended to provide additional understanding of the dose range and to evaluate the safety and efficacy of PRAX-114 at doses of 10, 20, 40 and 60 mg.
- Praxis expects topline results from the PRAX-114 Phase 2, placebo-controlled study for treatment of post-traumatic stress disorder (PTSD) in the second half of 2022. The trial is designed to evaluate the safety, tolerability and efficacy of a nightly dose of 40 mg of PRAX-114 for four weeks in approximately 80 participants with PTSD, using the CAPS-5 total score as the primary endpoint. An 8-week open-label extension period is available for all participants who complete the placebo-controlled portion of the study.
Movement Disorders
- Praxis reported positive topline results from Part B of its Phase 2a study evaluating the safety and efficacy of PRAX-944 for the treatment of essential tremor (ET). In the study, treatment with PRAX-944 resulted in clinically meaningful improvements in function, which were supported by improvements in tremor amplitude.
- The study included both an open-label and randomized withdrawal period. In the open-label period, participants were to be titrated up to a maximum dose of 120 mg over 28-days prior to a stable period at the highest dose reached from Day 29 to Day 42. Participants who remained in the study through Day 42 were then randomized one-to-one to either active drug or placebo from Day 43 to Day 56, with a subsequent safety follow-up visit at Day 70.
- In the open-label period through Day 42, patients treated with PRAX-944 demonstrated mean improvement from baseline of 42% in the Modified Activities of Daily Living (ADL) score (N=11, nominal p