SK Life Science, Inc. has submitted a Phase 3 clinical trial protocol to the US Food and Drug Administration (FDA) to assess the efficacy and safety of carisbamate for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS). The Phase 3 global, randomized, multicenter, double-blind, placebo-controlled trial will examine the efficacy of two carisbamate doses in over 250 patients aged 4-55. The FDA has designated carisbamate as an orphan drug for the potential treatment of LGS.

Source: SK Life Science, Inc.

Lennox-Gastaut syndrome is a rare and severe form of epilepsy that begins in childhood. It belongs to the group of a severe infantile epileptic syndrome (epileptic neonatal encephalopathy with suppression-burst, West syndrome, severe myoclonic epilepsy of infancy). People with Lennox-Gastaut syndrome start having seizures when they are young, usually between the ages of 3 and 5. LGS is also a physically dangerous epilepsy syndrome for children and teenagers due to frequent falls, injuries, and cognitive impairment, which can severely limit one’s quality of life. Children with infantile spasms or underlying brain disorders may be affected, but the cause can also be idiopathic. Antecedent conditions associated with LGS almost always involve the cerebral cortex. The cerebral cortex and the corpus callosum produce some of the phenomena of LGS. Among lesional causes, those involving both frontal lobes most commonly lead to LGS development. However, any brain damage may be associated with LGS, and this lack of specificity has impeded the clarification of neurophysiological mechanisms.

• The incidence of Lennox-Gastaut syndrome is very low, ~1% of childhood epilepsies in children <10 years old. About 68% of the LGS is mainly accounted for by children under the age of 18 years, and the adult population accounts for the remaining 38% of the LGS.

However, the current Lennox-Gastaut syndrome treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (ZX008, EPX-100, Carisbamate, Soticlestat, Clobazam, Rufinamide, 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 Lennox-Gastaut syndrome treatment. The key companies in the advanced development stage are Zogenix, Inc., Epygenix, SK Life Science, Inc., Takeda, Lundbeck LLC, Eisai Limited, etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Lennox-Gastaut syndrome (LGS) 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 2020 to 2030.

Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. 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

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