Company:

Flatley Discovery Lab

Summary

Clinical Operations

Specifically, NST coordinated and managed three Phase 1a/b studies for FDL all performed in the UK. This included:

Compilation and writing of the non-clinical IMPD, Investigator’s Brochure and the clinical protocol for all studies
Assembling and filing the Clinical Trial Application with the MHRA
Acting as legal representative for FDL in the UK
Monitoring the clinical trials on a regular basis to ensure protocol compliance
Providing regulatory advice as needed
Communicating study closeout to the competent authorities
Uploading study results to the EU clinical database.

What our client said

"All of their services were provided on time, on budget in a very professional manner. Every CTA was accepted by the regulatory authorities without major comment. To summarize, I can say without qualification that I without hesitation recommend Niche as a partner for your drug development activities."

John Ferkany

Flatley Discovery Lab

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Project background

Flatley Discovery Lab (FDL) was a biotechnology company based in Charlestown, Massachusetts. It focused on advancing innovative therapeutic approaches to treat cystic fibrosis (CF) and other genetic diseases. The main target of their drug discovery efforts was the restoration of the CTFR chloride channel protein, whose dysfunction is a major aetiological feature of CF. Founded by John Flatley, FDL was a privately funded lab that leveraged cutting-edge science to address unmet medical needs, particularly in respiratory health. The lab was known for its work on identifying small molecules and therapies that aimed to correct the underlying genetic and cellular defects associated with cystic fibrosis. FDL’s efforts contributed to the broader mission of improving patient outcomes and expanding treatment options in the field of rare diseases. The company finally closed in 2022 after unfavourable results from their combination treatment study.

Delivery

Flatley Discovery Lab, whose ambitious vision was to tackle CF via “correction” or “potentiation” of CTFR chloride channel protein, identified NST as a trusted regulatory and clinical operations partner. The NST team enabled FDL to actualise their combinatorial treatment approach that involved CFTR corrector and potentiation modes-of-action working synergistically. NST’s deep mechanistic knowledge and regulatory expertise proved instrumental in this. Close communication, meticulous planning and coordination between FDL and NST were key to the clinical programme. NST supported Phase 1a/b studies for FDL169, a CFTR corrector, and FDL176, a CFTR potentiator. This included study conduct and monitoring of UK-based studies, generation of regulatory deliverables such as IMPDs, IBs and clinical protocols, communication with competent authorities, and dissemination of study findings to the EU clinical database.