CONNECTA Therapeutics to Advance CTH120 into Phase II Pediatric Development for Fragile X Syndrome

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The biotechnology company CONNECTA Therapeutics, a member of Catalonia.health, has announced the launch of studies for the paediatric development program of CTH120, an investigational FXS treatment, following positive results from the Phase I trial.

Supported by a €2.5 million grant from the EIC Accelerator as part of the FRAXCURE project (Grant agreement No. 101217931), CONNECTA is one of just 71 companies selected from over 1,200 applicants in the October 2024 call. The grant will enable CONNECTA to complete critical regulatory and preclinical activities, including safety studies, development of an age-appropriate oral formulation, and submission of its Paediatric Investigation Plan to support regulatory approval for a future Phase II trial of CTH120 in paediatric FXS patients. CONNECTA is also planning a Phase IIb trial in adults to further expand clinical evidence supporting CTH120.

CONNECTA’s lead program, CTH120, is a first-in-class, disease-modifying therapy for FXS. CTH120 has strong preclinical and positive Phase I data demonstrating excellent safety, tolerability, and pharmacokinetics in healthy adult volunteers. Built on CONNECTA’s proprietary neuroplasticity modulation platform, CTH120 is uniquely positioned to address unmet needs in FXS. It serves as a proof of concept for the expansion of this disease-modifying approach into other central nervous system disorders, including Rett syndrome, Down’s syndrome, DiGeorge syndrome, autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), and neuropathic pain.

Jordi Fàbrega, Co-Founder & CEO of CONNECTA Therapeutics, said: “There are no approved treatments for FXS, a devastating disorder affecting children’s cognitive development, behaviour, and quality of life for them and their families, lasting a lifetime. CTH120 has the potential to redefine FXS care through a disease-modifying novel mechanism of action that represents a significant technological advantage. The EIC Accelerator grant is a game-changer – accelerating our mission to deliver hope and lasting impact to families. We are honoured to have been selected for funding in one of the most competitive rounds of applications since the launch of the EIC Accelerator program under Horizon Europe.”

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