Sareum Holdings is preparing to initiate Phase II clinical trials for its lead asset, SDC-1801, a dual TYK2/JAK1 inhibitor, following the successful completion of Phase I trials in Australia. The drug is being developed for the treatment of psoriasis, a chronic autoimmune condition affecting millions worldwide. The advancement marks a significant step forward in Sareum's clinical development program.
The recently reported unblinded data from the Phase I trials highlighted SDC-1801's robust pharmacokinetic (PK) and pharmacodynamic (PD) properties. These findings, coupled with the drug's desirable safety profile, support its continued development as a potential treatment for psoriasis. The Phase II trial is expected to be a larger study than the previously proposed Phase Ib trial, necessitating a long-term (approximately 16 weeks) toxicology study prior to commencement.
"The positive data from the Phase I trials are encouraging and provide a strong foundation for the Phase II development of SDC-1801," said a Sareum spokesperson. "We believe that SDC-1801 has the potential to offer a significant benefit to patients with psoriasis."
To support the Phase II preparatory activities and preclinical work on its second asset, SDC-1802, Sareum recently secured £3.4 million in equity funding and a further approximately £1 million in R&D tax credits. Management believes this funding will be sufficient to complete the necessary preclinical and preparatory work.
Given the costs associated with Phase II clinical trials, Sareum is actively seeking partnering opportunities to support the further development of SDC-1801. This strategic approach aims to leverage external resources and expertise to accelerate the drug's progress through the clinical development pathway and maximize its potential for commercialization.
Psoriasis is a chronic autoimmune disease characterized by raised, scaly patches on the skin. Current treatments include topical corticosteroids, phototherapy, and systemic immunosuppressants. However, many patients do not respond adequately to these therapies, highlighting the need for new and effective treatment options. SDC-1801's dual TYK2/JAK1 inhibition mechanism offers a novel approach to targeting the underlying inflammatory pathways involved in psoriasis.
