Biopharmaceutical firm Symic Bio has started patient enrolment in a Phase II clinical trial (MODIFY2) of its product candidate SB-061 to treat osteoarthritis of the knee.
SB-061 is a therapeutic bioconjugate being developed for direct delivery to the joint through intra-articular injection.
The therapeutic candidate is designed to target the degrading extracellular matrix to minimise the inflammatory cycle that is known to drive the signs and symptoms of progressive osteoarthritis.
Through the direct approach, SB-061 is expected to alter the disease course by decreasing joint degradation, pain and functional decline caused by inflammation in the joint.
The 12-week, multi-centre, double-blinded Phase II trial will assess SB-061 for pain management in patients with mild-to-moderate osteoarthritis of the knee.
Symic Bio chief medical officer Nathan Bachtell said: "By addressing the degradation of cartilage that is fundamental to disease pathology, SB-061 is intended to both manage pain and modify the course of disease.
“We are looking forward to efficacy results and MRI imaging data and expect to provide a top-line analysis of MODIFY2 and MODIFY-MRI results in early 2018."
The firm intends to carry out a concurrent magnetic resonance imaging study (MODIFY-MRI) to investigate the short-term physical modifications of disease process due to the SB-061 treatment.
The MODIFY-MRI study intends to gather the data required to determine the potential of SB-061 as a long-term disease-modifying agent, and will involve monitoring of the inflammation process.
The results from a previous Phase I/IIa trial demonstrated positive safety, tolerability and intended mechanism of action of SB-061.
Image: Osteoarthritis of the knee. Photo: courtesy of BruceBlaus.