FOI release

Freedom of Information request (FOI 22/940)

Published 17 January 2024

FOI 22/940

30th September 2022

Dear

Thank you for your information request, dated 01 September 2022, where you asked for

‘access to the complete information held on file by the MHRA regarding the Clinical Trial being conducted by Sangamo Therapeutics, Inc. in the UK, as detailed below.

Full title of the trial: A Phase I/II, Multicenter, Open-Label, SingleDose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, a rAAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects with Fabry Disease

Sponsor’s Protocol Code Number: ST-920-201

EudraCT Number: 2019-000667-24

I request this information in electronic format but will accept paper copies if electronic format is not available.’

I am pleased to provide you with some of the information requested, attached to this email.

These documents are provided with any personal information redacted as well as any information specific to the structure or molecular formula and manufacturing process or considered commercially sensitive, under section 40, 41 and 43 of the Freedom of Information Act.

Unfortunately, other application documentation is exempt from release under section 41 and 43 of the Freedom of Information Act:

The information was provided to us in confidence, with the expectation that it will not be released, and is therefore exempt from disclosure under Section 41 of the Freedom of Information Act. Disclosure would also likely prejudice commercial interests and therefore exemption under Section 43 also applies.

Section 41 is an absolute exemption and no consideration of the balance of public interest is required. Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any overriding argument for releasing the information that outweighs the commercial harm by providing potential competitors with an insight into the product development and design of this study.

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Kind Regards,

MHRA Customer Experience Centre