A new diagnostic drug approved in the EU for the visualisation of colorectal lesions during colonoscopies.
The results of our Methylene Blue MMX® pivotal phase III study were announced in November 2016.
The primary endpoint, adenoma detection rate or ADR, was attained, identifying 17.71% more patients with at least one or more adenoma when the patients took Methylene Blue MMXR
prior to the endoscopy procedure compared with Standard of Care White Light colonoscopy with High Definition endoscopes.
ADR is a key colonoscopy quality indicator and is defined as the % of patients undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed.
In the phase III clinical trial, the false positive rate (an important secondary endpoint) in the Methylene Blue MMX® arm was lower than in the WLHD. In the Methylene Blue MMX® arm, 356 subjects out of 485 subjects had an excision. Eighty-three of these subjects (23.3%) were false positives. In the WLHD arm, 326 out of 479 subjects had an excision and 97 of these subjects (29.7%) were false positives.
In February 2019, we filed a Marketing Authorisation Application for Methylene Blue MMX® 200mg tablets with the European Medicines Agency.
In August 2020, the European Commission approved Methylene Blue MMX® for the visualisation of colorectal lesions during colonoscopies and in February 2021 we licensed the E.U. rights (plus Switzerland, the U.K., E.E.A. countries, Russia and Mexico) to Alfasigma S.p.A.
Methylene Blue MMX® U.S.
Our New Drug Application (NDA) for Methylene Blue MMX® was submitted to the U.S. Food and Drug Administration (FDA) in July 2017. In May 2018, we received a Complete Response
Letter (CRL) from the F.D.A. The CRL stated that while the outcome of the phase III trial had translated in a statistically significant outcome the outcome was not sufficiently ‘robust’
and recommended that we provide confirmation of effectiveness with a second phase III trial.
Discussions are ongoing with the FDA in relation to the confirmatory phase III trial required for U.S. registration.