Knee trial for Merck KGaA
pharmafile | March 19, 2013 | News story | Research and Development, Sales and Marketing | Merck KGaA, knee, nordic
Merck KGaA is to begin a Phase IIb trial of its investigational drug sprifermin in patients with osteoarthritis (OA) of the knee.
The German company will collaborate with Nordic Bioscience Clinical Development, which is providing clinical development muscle in return for service fees plus potential milestone and royalty payments.
Merck will retain full responsibility for developing and commercialising sprifermin (recombinant human FGF-18) in what is described as a ‘shared-risk’ deal.
Both companies have drawn a veil over the finances of the agreement, revealing only that the multi-national FORWARD study is to start enrolment in the second half of the year.
Susan Herbert, Merck Serono’s executive vice president of global business development and strategy, says Nordic’s “deep expertise in OA and proven track record of specialist trial recruitment will enable us to effectively and efficiently move to the next stage of clinical evaluation for sprifermin”.
Two Phase I trials in moderate-to-severe OA of the knee have been completed, and a Phase II trial to evaluate the efficacy and safety of sprifermin in patients with cartilage injury of the knee is ongoing.
FORWARD will look at whether sprifermin can stop or slow the progression of structural damage to the knee caused by OA, or help reduce pain and improve physical function in patients.
The protein, in-licensed in 2004 from Bristol-Myers Squibb’s ZymoGenetics, is delivered by intra-articular injection.
It is thought to work by inducing chondrocyte stimulation which in turn leads to matrix synthesis and chondrocyte renewal.
OA of the knee is a painful and relatively widespread condition. According to data from the World Health Organisation, more than 5% of adults over 40 in developed countries – which is more than 30 million people – suffer from OA of the knee.
“Partnering with Merck allows us to utilise our clinical trial and biomarker expertise within musculoskeletal diseases,” said Nordic’s founder Claus Christiansen.
Adam Hill
Related Content
Exscientia enters AI drug discovery collaboration with Merck KGaA
Exscientia has announced a new collaboration with Merck KGaA, Darmstadt, Germany, with a focus on …
Merck KGaA’s cancer drug Bavencio gets EU approval
The EC has approved Merck KGaA’s BAVENCIO (avelumab) as monotherapy for the first-line maintenance treatment …
Company veteran Belén Garijo named as Merck KGaA’s first-ever female CEO
German pharma firm Merck KGaA has taken the decision to appoint its first female Chief …
