Company:

ReCode Therapeutics

ReCode Therapeutics Inc.

Summary

ReCode eager to conduct their first study in patients in a leading London hospital and needed a CRO with experience in the respiratory field and working with academic/NHS sites. The ReCode team recognised Niche as a trusted regulatory and clinical operations partner with the required experience and attributes. Specifically, Niche coordinated and managed our first patient study in the UK. This included:

Compilation and writing of the IMPD, Investigator’s Brochure, clinical protocol and associated documents
Assembling and filing the Clinical Trial Application with the MHRA
Site management, vendor coordination and clinical trial monitoring to ensure protocol compliance
Provision of regulatory advice and agency communication as required
Study reporting and dissemination of the key findings through scientific publications

What our client said

"Niche have been involved in preparing many of our clinical and regulatory documents and they are also engaged in managing one of our Phase I/II studies. I continue to work closely with the Niche team being very satisfied with their broad range of abilities, flexibility and quality. I am pleased to endorse and recommend Niche to any prospective sponsor requiring regulatory advice, clinical operations or medical writing support."

Dr John Matthews, CMO

ReCode Therapeutics

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Project background

ReCode Therapeutics is a US-based, clinical-stage genetic medicines company developing therapeutics for genetically defined diseases with no existing treatment options including primary ciliary dyskinesia and cystic fibrosis. ReCode uses superior delivery to power the next wave of messenger (mRNA) and gene correction therapeutics. ReCode’s selective organ targeting (SORT) lipid nanoparticle (LNP) platform is a next-generation, genetic medicines technology that enables precise delivery to target organs and cells beyond the liver. ReCode’s technology aims to transcend the limitations of current genetic medicine delivery systems so that people with rare diseases may fully benefit from disease-modifying, corrective therapeutics. ReCode eager to conduct their first study in patients in a leading London hospital and needed a CRO with experience in the respiratory field and working with academic/NHS sites.

Delivery

ReCode Therapeutics, whose ambitious vision is to develop genetic therapeutics for defined diseases with no existing treatment options including primary ciliary dyskinesia and cystic fibrosis recognised Niche as a trusted regulatory and clinical operations partner. The Niche team enabled ReCode to actualise their treatment approach from their base in California, USA. Niche’s scientific understanding, therapy area experience and regulatory expertise have proved instrumental in this. Close communication, meticulous planning and coordination between ReCode and Niche have been key to delivery of the clinical programme - this included:

Compilation and writing of the IMPD, Investigator’s Brochure, clinical protocol and associated documents
Assembling and filing the Clinical Trial Application with the MHRA
Site management, vendor coordination and clinical trial monitoring to ensure protocol compliance
Provision of regulatory advice and agency communication as required
Study reporting and dissemination of the key findings through scientific publications

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