Traficet-EN (CCX282-B), a specific CCR9 antagonist with the potential to offer a new approach for the treatment of inflammatory bowel diseases, including crohn’s disease.
Reportedly, the option also encompasses two further identified backup compounds and represents the first product licensing opportunity resulting from the original collaboration with ChemoCentryx through GSK’s Centre of Excellence for External Drug Discovery (CEEDD).
As per the terms of the collaboration, ChemoCentryx is expected to receive an option exercise fee of $35m and may be eligible for further regulatory milestone payments. Following successful development and commercialisation of any of the candidate compounds, ChemoCentryx will also receive royalties on product sales with the ability to increase royalties by co-funding development through Phase III clinical trials and co-promoting to physician specialists in North America.
Furthermore, GSK will now assume responsibility for the continued development of CCX282-B in patients with moderate-to-severe crohn’s disease. Potential ulcerative colitis studies will also be considered for the product candidate.
The alliance provides GSK with access to certain drug candidates and their associated back-ups against pre-defined targets, with licensing options following successful completion of clinical proof-of-concept.
ChemoCentryx has recently completed and reported results from the placebo controlled Phase II Protect-1study with CCX282-B, which demonstrated evidence of clinical efficacy in the reduction of disease severity in induction therapy, whilst results from the maintenance arm demonstrated clinical efficacy in maintenance of remission in patients with moderate-to-severe crohn’s disease. CCX282-B was shown to be well-tolerated after use up to one year.
Thomas Schall, president and CEO of ChemoCentryx, said: “GSK’s option exercise of CCX282-B is validation of ChemoCentryx’s discovery and development capabilities and confirms the promise of our chemokine targeted development programmes, many of which involve entirely new mechanisms of therapeutic action that have never been successfully regulated before.
“We are especially pleased with the progress and results of the Protect-1 study, as it represents the first definitive clinical evidence that chemokine receptors can be successfully targeted to treat a major inflammatory disease such as crohn’s. Working with a partner of GSK’s calibre has been inspiring and we look forward to the further advancement of CCX282-B as well as the additional programmes that comprise our alliance.”