KER-0193 is a modulator of ion channels connected to autism spectrum disorder. The FDA bestowed orphan drug and rare pediatric drug designations on the candidate earlier this year.
Servier is again reaching into its purse, this time looking to bolster its neuro pipeline with Kaerus Bioscience’s fragile X syndrome candidate.
Under the agreement, announced Monday, the U.K. startup could get up to $450 million from Servier, inclusive of the upfront payment and if all development and commercial milestones are met. The terms of the deal were not broken down into upfront commitments and downstream milestones and royalties.
In exchange for its investment, Servier will acquire KER-0193, an investigational small-molecule drug being tested for fragile X syndrome, the most common genetic cause of autism spectrum disorder, per the company’s announcement.
According to Kaerus’ website, KER-0193 is a modulator of BK channels, calcium-activated ion channels that, when dysfunctional, can lead to hyper-excitability of the central nervous system. KER-0193 is designed to be orally available and has been shown, in preclinical studies, to improve behavioral, sensory and cognitive symptoms related to fragile X syndrome, according to Mondays’ release. Kaerus in March completed a Phase I study of the asset, touting “significant pharmacodynamic effects” on relevant parameters of brain activity.
In May, the FDA granted KER-0193 its orphan drug and rare pediatric drug designations for fragile X syndrome.
With Monday’s deal, Servier will now assume responsibility over the development of KER-0193, for which it plans to launch a Phase II study next year in America and Europe.
Affecting 1 in 7,000 males and 1 in 11,000 females worldwide, fragile X syndrome is a rare genetic condition characterized by cognitive and developmental delays, crossed eyes, behavioral problems and mental health conditions such as anxiety and depression. The underlying genetic cause of fragile X syndrome is also associated with impaired BK channel function, according to Kaerus.
For Servier, the Kaerus deal comes on the heels of another hefty contract. Last week, the French pharma dropped $210 million upfront to partner with IDEAYA Biosciences and advance its investigational kinase inhibitor darovasertib for uveal melanoma, a rare eye cancer. The agreement includes up to $210 million in commercial milestones and up to $100 million in regulatory milestones, plus royalties.
In March, Servier likewise joined hands with Black Diamond, licensing the Boston biotech’s small molecule drug BDTX-4933 for $70 million upfront and the promise of $710 million in development and sales milestones. In that deal Black Diamond will also be entitled to royalties. BDTX-4933 is in early-stage development for solid tumors but was deprioritized in October 2024 due to cash constraints.
