PRAX562 Emerging Drug Insight

“PRAX562 Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about PRAX562 for Developmental and Epileptic Encephalopathy in the 7MM. A detailed picture of the PRAX562 for Developmental and Epileptic Encephalopathy in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019–2032 is provided in this report along with a detailed description of the PRAX562 for Developmental and Epileptic Encephalopathy. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the PRAX562 market forecast, analysis for Developmental and Epileptic Encephalopathy in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about emerging therapies in Developmental and Epileptic Encephalopathy.

Drug Summary

PRAX-562 is a preferential, persistent sodium current blocker that is designed to reduce pathological neuronal hyperexcitability and provide an improved tolerability profile. PRAX-562 is in development for the treatment of a broad range of rare, devastating CNS disorders, such as severe pediatric epilepsies and adult cephalgias.

Praxis completed a Phase I trial of PRAX-562 in Australia to evaluate the safety, tolerability, PK, and effects on an exploratory EEG biomarker in up to 129 adult healthy volunteers. PRAX-562 was well-tolerated, with no clinically significant safety findings. In the study, auditory steady-state response, or ASSR, was used as an exploratory EEG biomarker to determine the doses required to achieve pharmacological blockade of persistent sodium current, which is believed to be a potential indicator of efficacy in patients. Based on the observed signal in the ASSR biomarker in the Phase I trial, the company started dosing patients in the US in a Phase I, placebo-controlled, two-cohort study to further evaluate the observed ASSR signal and to evaluate 28-day dosing, for which topline data is expected to be reported in the second quarter of 2022. The company also expects to initiate a Phase II study with PRAX-562 by the end of 2022 in patients with rare pediatric DEEs.

Additionally, Praxis’ lead product candidate for treating epilepsy is PRAX-222, an antisense oligonucleotide, designed to lower the expression levels of the protein encoded by the gene SCN2A in patients with GOF mutations in SCN2A, which is the underlying cause of SCN2A-GOF DEE, has completed IND-enabling toxicology studies.

Scope of the Report

The report provides insights into:

•  A comprehensive product overview including the PRAX562 description, mechanism of action, dosage and administration, research and development activities in Developmental and Epileptic Encephalopathy.
•  Elaborated details on PRAX562 regulatory milestones and other development activities have been provided in this report.
•  The report also highlights the PRAX562 research and development activity in Developmental and Epileptic Encephalopathy details across the United States, Europe and Japan.
•  The report also covers the patents information with expiry timeline around PRAX562.
•  The report contains forecasted sales of PRAX562 for Developmental and Epileptic Encephalopathy till 2032.
•  Comprehensive coverage of the late-stage emerging therapies for Developmental and Epileptic Encephalopathy.
•  The report also features the SWOT analysis with analyst views for PRAX562 in Developmental and Epileptic Encephalopathy.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

PRAX562 Analytical Perspective by DelveInsight

• In-depth PRAX562 Market Assessment

This report provides a detailed market assessment of PRAX562 in Developmental and Epileptic Encephalopathy in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data of PRAX562.

• PRAX562 Clinical Assessment

The report provides the clinical trials information of PRAX562 for Developmental and Epileptic Encephalopathy covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights 

•  In the coming years, the market scenario for Developmental and Epileptic Encephalopathy is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.  
•  The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence PRAX562 dominance.
•  Other emerging products for Developmental and Epileptic Encephalopathy are expected to give tough market competition to PRAX562 and launch of late-stage emerging therapies in the near future will significantly impact the market.
•  A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of PRAX562 in Developmental and Epileptic Encephalopathy.
•  Our in-depth analysis of the forecasted sales data of PRAX562 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the PRAX562 in Developmental and Epileptic Encephalopathy.

Key Questions

•  What is the product type, route of administration and mechanism of action of PRAX562?
•  What is the clinical trial status of the study related to PRAX562 in Developmental and Epileptic Encephalopathy and study completion date?
•  What are the key collaborations, mergers and acquisitions, licensing and other activities related to the PRAX562 development?
•  What are the key designations that have been granted to PRAX562 for Developmental and Epileptic Encephalopathy?
•  What is the forecasted market scenario of PRAX562 for Developmental and Epileptic Encephalopathy?
•  What are the forecasted sales of PRAX562 in the 7MM, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan? 
•  What are the other emerging products available in Developmental and Epileptic Encephalopathy and how are they giving competition to PRAX562 for Developmental and Epileptic Encephalopathy?
•  Which are the late-stage emerging therapies under development for the treatment of Developmental and Epileptic Encephalopathy?