Grünenthal has recruited first patients in two trials of pivotal phase III program to investigate neridronate for the treatment of Complex Regional Pain Syndrome (CRPS).
These two trials, KF7013-02 and KF7013-04, are investigating the efficacy and safety of neridronate in 360 patients with CRPS. Neridronate, a bisphosphonate, is an innovative investigational medicine discovered and developed by Abiogen Pharma and now being further developed by Grünenthal for the US territory.
CRPS is a rare disease and one of the most debilitating chronic pain conditions. Currently, with no FDA or EMA approved drugs available, there is a clear need for effective treatment options to address this significant unmet medical need. As a leading specialist in pain therapy and pain management, Grünenthal is highly committed to providing an innovative treatment for patients affected by CRPS.
"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.
“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," said Gabriel Baertschi, CEO Grünenthal.
"I'm excited to be part of a pivotal phase III efficacy trial in CRPS. Currently, there is no approved treatment available and affected patients face a permanently high pain level and immense restrictions in their daily life," said Prof. Claudia Sommer, International Coordinating Investigator for one of the trials.
"If the efficacy of neridronate is confirmed, quality of life of the patients could be significantly improved."
KF7013-02 and KF7013-04 are confirmatory phase III efficacy and safety trials to investigate neridronate's effect on pain and other CRPS symptoms like swelling/edema and allodynia. The primary endpoint assesses the pain reduction after twelve weeks in comparison to placebo. The trials are conducted in the US, EU and certain countries in the Asia Pacific region.
Source: Company Press Release