Green Cross Partners with US Spheragen to Develop Treatment for Rare SSADHD Disease
[Asia Economy Reporter Lee Chun-hee] GC Green Cross is partnering with the US company Speragen to develop a treatment for the rare and intractable disease 'Succinic Semialdehyde Dehydrogenase Deficiency (SSADHD)'.
GC Green Cross announced on the 20th that it has signed a joint development agreement for an SSADHD treatment with Speragen.
SSADHD is a recessively inherited neurodegenerative disorder caused by enzyme deficiency due to a genetic defect. It is known to occur around the age of one, with an incidence of about one in one million people. Representative symptoms include epilepsy, motor skills impairment, and intellectual developmental delay. Currently, there is no treatment available, and only anticonvulsants are prescribed to alleviate seizure symptoms.
Through this agreement, the two companies will develop an enzyme replacement therapy (ERT) using the SSADH protein. The goal is to create the world's first treatment for SSADHD.
GC Green Cross will receive rights from Speragen related to patents on plasmids for producing the SSADHD protein through this contract. Previously, in 2019, Speragen secured exclusive rights to the original patent from Washington State University.
In the joint development process, GC Green Cross will leverage its proven enzyme therapy technology, validated through products like Hunterase, to conduct formulation development, clinical trials, and biomarker research. Speragen will handle the Patient-Focused Drug Development (PFDD) process with the US Food and Drug Administration (FDA) and the newborn screening process to identify new patients locally. Preclinical trials are set to begin this year, with the goal of entering Phase 1/2 clinical trials in the second half of 2023.
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Huh Eun-chul, CEO of GC Green Cross, stated, “Through this collaboration, we will be able to strengthen our rare disease pipeline,” adding, “We will become a global rare disease specialist pharmaceutical company dedicated to patients and healthcare professionals alike.”
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