Stoke Therapeutics Receives FDA Approval to Administer Higher Single Dose of STK-001 in MONARCH Trial for Dravet Syndrome

Stoke Therapeutics’ experimental therapy for Dravet syndrome is being tested in the U.S.-based Phase 1/2a MONARCH trial, where a higher single dose of STK-001 will be administered. The U.S. Food and Drug Administration (FDA) has authorized Stoke to test a 70 mg dose in the MONARCH study (NCT04442295), which will complement the ongoing parallel Phase 1/2a ADMIRAL trial (ISRCTN99651026) in the U.K. where multiple 70 mg doses are being tested.

Publish Date: 15-04-2023 Source: Stoke Therapeutics

Dravet syndrome, or Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare and fatal form of intractable epilepsy that manifests itself in childhood. Initial seizures are frequently prolonged, and other types emerge in the second year of life. It is a severe form of epilepsy that is characterised by frequent, prolonged seizures that are frequently triggered by high body temperature (hyperthermia), developmental delay, sleep disturbance, ataxia, hypotonia, speech impairment, and other health problems.

Dravet syndrome is a rare genetic disorder affecting approximately 1 in every 20,000–40,000 births in the US. Approximately 3% to 8% of children who experience their first seizure before the age of 12 months may develop Dravet syndrome.

However, the current Dravet Syndrome (DS) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Soticlestat, ZX008, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Dravet Syndrome treatment. The key companies in the advanced development stage are Takeda, Zogenix, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Dravet Syndrome (DS) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

About Thelansis:

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.