Janssen has kicked off a Phase II/III programme assessing Tremfya in Crohn's Disease.
The GALAXI programme, which will consist of a Phase II study (GALAXI 1) followed by two Phase III studies (GALAXI 2 and GALAXI 3), is expected to enroll around 2,000 patients.
Safety and efficacy of Tremfya (guselkumab) will be evaluated in patients with moderately to severely active forms of Crohn's disease, an inflammatory bowel disease for which there is no cure.
Tremfya is a fully human anti-IL-23 monoclonal antibody developed by Janssen, generated utilising MorphoSys's proprietary HuCAL antibody technology, which is already approved in Europe and the US as a treatment for psoriasis.
"We are very pleased that our licensee Janssen has started a pivotal Phase II/III development program in Crohn's disease, a severe illness where significant unmet needs exist despite the availability of some effective therapies. If successful, this could result in a further expansion of the therapeutic range of Tremfya,” noted MorphoSys’ chief scientific officer Dr Markus Enzelberger.
The move into Phase II/III trials triggers two undisclosed milestone payments to MorphoSys from Janssen.