Gruenenthal has kicked off two pivotal Phase III trials investigating the bisphosphonate neridronate for the treatment of Complex Regional Pain Syndrome (CRPS).
CRPS is a rare, debilitating chronic pain condition for which there is currently no treatment approved in the US or the EU, highlighting a clear need for effective therapeutic options.
"There is a huge unmet medical need in CRPS as this condition may result in loss of the physical function and may lead to significant and sometimes permanent disability,” noted Gabriel Baertschi, Gruenenthal’s chief executive.
“Neridronate has been granted Breakthrough Therapy and Fast Track designation by the FDA and our pivotal Phase III development program is the next step to investigate neridronate's potential to make a difference in the lives of patients affected by this debilitating disease.”
KF7013-02 and KF7013-04 are confirmatory Phase III efficacy and safety trials designed to investigate the drug’s effect on pain and other CRPS symptoms like swelling/edema and allodynia.
The primary endpoint of the trials, which will involve around 360 patients, will assess pain reduction after twelve weeks of therapy in comparison to placebo.
"If the efficacy of neridronate is confirmed, quality of life of the patients could be significantly improved,” said Professor Claudia Sommer, international coordinating investigator for one of the trials.