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Intellia Therapeutics Awarded Innovation Passport in the United Kingdom for NTLA-2002, an Investigational Genome Editing Treatment for Hereditary Angioedema
Innovation Passport provides entry to the U.K.’s Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate
About this update from Intellia Therapeutics, Inc.
[{"type":"text","content":"Innovation Passport provides entry to the U.K.’s Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to innovative medicines NTLA-2002 is a single-dose genome editing therapeutic candidate designed to prevent angioedema attacks in people with hereditary angioedema (HAE) CAMBRIDGE, Mass., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Innovation Passport for NTLA-2002, an in vivo genome editing candidate being developed for the treatment of hereditary angioedema (HAE). The Innovation Passport is the point of entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP), which is designed to accelerate time to market and facilitate patient access to innovative medicines. “With the high treatment burden of currently available chronic therapies for hereditary angioedema, we are pleased to receive the ILAP designation, which will enable Intellia to further accelerate the clinical development of NTLA-2002,” said Intellia President and Chief Executive Officer John Leonard, M.D. “We expect to begin the Phase 2 portion of the NTLA-2002 clinical study in the first half of this year, and we look forward to working with the U.K. and other regulatory agencies to bring this investigational single-dose genome editing treatment to patients as quickly as possible.” The Phase 1/2 study evaluating NTLA-2002 in adults with Type I or Type II HAE is currently ongoing, with the Phase 2 portion expected to initiate in the first half of 2023. Delivered in partnership by the All Wales Therapeutics and Toxicology Centre (AWTTC), the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC), the Innovation Passport prioritizes innovative medicines in early clinical development stages for the treatment of diseases with a significant patient or public health need. Benefits of the ILAP include access to a Target Development Profile, which defines key regulatory and development features and creates a roadmap for advance...