Now that Ovid Therapeutics Inc.’s and Takeda Pharmaceutical Co. Ltd.’s phase II study of soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) has produced positive top-line data, Ovid is planning the drug’s phase III clinical trial while pricing a $50 million common stock offering.
Chief Business Officer David McNinch told BioWorld that South San Francisco-based Encoded Therapeutics Inc.’s $135 million from an oversubscribed series D financing follows by about a year the hefty series C round that “helped us get the [lead gene therapy] program poised to its current stage, which is IND-enabling studies.” The asset, ETX-101 for SCN1A-positive Dravet syndrome (DS), is expected to enter human trials next year.
While the FDA approved Zogenix Inc.’s Fintepla (fenfluramine), an oral treatment for patients ages 2 and older with seizures associated with Dravet syndrome, a rare, pediatric-onset form of epilepsy, the company stock continued its months-long struggle.
Stoke Therapeutics Inc. is marching ahead in the second half of this year with its phase I/IIa study with STK-001 in Dravet syndrome (DS), one of the more abysmal forms of epilepsy, although the FDA has temporarily hobbled part B of the test, pending preclinical data that will more fully characterize the safety profile of the antisense oligonucleotide (ASO).
According to the U.S. Epilepsy Foundation, one in 26 people in the country will develop epilepsy at some point in their lives and the condition is the fourth most common neurological disease that affects people of all ages. That is why the current anti-epilepsy drug therapy market is large and estimated to be worth more than $8.5 billion currently, rising to in excess of $9.5 billion in five years.
