Sigilon Therapeutics Announces Acceptance of Clinical Trial Application in the UK for SIG-005 for the Treatment of Mucopolysaccharidosis Type I
CAMBRIDGE, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Sigilon Therapeutics, Inc. (NASDAQ: SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has accepted the Company’s Clinical Trial Application (CTA) for SIG-005 in Mucopolysaccharidosis Type I (MPS-1), a chronic, progressive lysosomal disease.
SIG-005 contains a human cell line genetically modified with a non-viral vector designed to express human a-L-iduronidase (IDUA), an enzyme which is missing or defective in patients with MPS-1. The IDUA enzyme is essential for the breakdown of glycosaminoglycans (GAGs) in the lysosomes of patients with MPS-1, as the progressive accumulation of GAGs results in multi-organ involvement.
“With its impact on many systems throughout the body, MPS-1 presents unique treatment challenges and presently requires regular maintenance therapy that can place a significant burden on patients and their families,” said Rogerio Vivaldi, M.D., President and Chief Executive Officer of Sigilon. “Our goal with SIG-005 is to develop a non-viral, durable, redosable, and controllable approach that can deliver sustained levels of IDUA to patients with MPS-1. With this approval, we remain on track to initiate our Phase 1/2 study in the UK in the second half of this year.”
The Company has also filed a CTA in Brazil and plans to submit an Investigational New Drug Application with the U.S. Food and Drug Administration.
About Sigilon Therapeutics
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