Sovargen Co., Ltd. has dosed the first patient in a Phase 1b/2a trial of paxalisib for intractable epilepsy associated with focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC), triggering a $2 million development milestone payment to Kazia Therapeutics Limited. Sovargen exclusively licensed paxalisib from Kazia to develop and commercialize the drug for mTORopathy-related epilepsies worldwide, excluding mainland China, Hong Kong, Macao and Taiwan. The agreement, signed in March 2024, provides for up to $17 million in additional development and regulatory milestones, alongside sub-licensing revenue and royalties on net sales. Paxalisib is an oral, brain-penetrant dual inhibitor of PI3K and mTOR, pathways whose overactivation contributes to treatment-resistant seizures in these rare, genetically driven disorders. Kazia remains focused primarily on oncology, while Sovargen is advancing the epilepsy program. The companies said enrollment and clinical data generation will continue, subject to the risks associated with early-stage development, clinical trials, regulatory review and third-party licensing arrangements.