Company: 

Funxional Therapeutics Ltd

Funxional Therapeutics Ltd

Funxional Therapeutics Ltd was a privately-held pharmaceutical start-up. Support services provided by Niche included:

  • Investigational Medicinal Product Dossier
  • Investigator's Brochure
  • Clinical study protocol
  • Clinical Trial Application submission to the MHRA
What our client said

"Our team have found everyone at Niche to be polite, well informed and professional in their approach. They played key roles in our project, making contributions in a capable fashion within the required scope and timelines. Management of the team is excellent, the native English-speaking writers provide confidence in the written documents and fosters clear communication."

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Dr Konstantinos Efthymiopopulos

Funxional Therapeutics




Project background
Funxional Therapeutics Ltd was a privately-held pharmaceutical start-up. It was set up in 2005 to commercialise the development of broad-spectrum chemokine inhibitors (BSCIs, also known as somatotaxins), a new class of anti-inflammatory drugs discovered by Dr David Grainger, Cambridge University and Dr David Fox, Warwick University. Their lead BSCI candidate, FX125L, underwent Phase 1 and Phase 2 clinical studies for the treatment of inflammatory diseases. On the back of promising clinical findings, Funxional’s FX125L and BSCI programme was acquired by global pharmaceutical company, Boehringer Ingelheim, in 2012.
Delivery

Niche provided a broad range of services, as a trusted CRO to help Funxional realise its vision for FX125L, as a therapeutic option in a range of chronic inflammatory diseases, including asthma, chronic obstructive pulmonary disease, rheumatoid arthritis and psoriasis. This included clinical trial conduct, submission of clinical trials applications to the MHRA, as well as medical writing for clinical protocols, an Investigational Medicinal Product Dossier and Investigator Brochures. NST’s project management was critical in this partnership. NST integrated seamlessly with Funxional’s team members, paying close attention to project scope and timelines to ensure efficient project delivery.

FX125L targeted a unique inflammatory pathway that was discovered by Funxional. Niche’s clinical expertise was useful in translating this mechanistic knowledge into clinical evidence. The promising findings generated in Niche-supported studies caught the attention of Boehringer Ingelheim, who acquired the rights to FX125L and Funxional’s broader BSCI programme.

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