04:09 AM EDT, 06/30/2025 (MT Newswires) -- Klotho Neurosciences ( KLTO ) said Monday that it is beginning manufacturing and development work in preparation for clinical trials of KLTO-202, its investigational gene therapy for amyotrophic lateral sclerosis.

The company said expects that it will take approximately eight months to complete process development and manufacturing of KLTO-202, a unique RNA splice variant of the human gene licensed from the Autonomous University of Barcelona,

and about four to six months to conduct meetings with FDA, complete all FDA-mandated animal safety studies, file an investigational new drug application, train and prepare clinical sites where the phase 1 and 2 studies can be conducted.

The company expects to begin single-dose gene therapy studies in patients by Q3 2026.

The company said it will retain contract research organizations to conduct the preparatory work and the clinical trials to reduce operating overhead.

Amyotrophic lateral sclerosis is rapidly progressing disease causing patients to losing mobility and eventually respiratory function within two or three years of diagnosis.