Shinpoong Pharmaceutical said the Ministry of Food and Drug Safety (MFDS) on Thursday approved its phase 3 trial clinical plan for SP5M002 (ingredient: sodium hyaluronate), an investigational knee osteoarthritis drug.

The study, which will be randomized, double-blind, and active-controlled, will evaluate the efficacy and safety of intra-articular administration of SP5M002 in patients with knee osteoarthritis.

The drug candidate will be tested on 292 adults with mild to moderate knee osteoarthritis. 

Patients enrolled in the clinical trial will receive either a single or repeat intra-articular injection of SP5M002 or active control to evaluate post-dose efficacy and safety.

The study will evaluate the treatment's effectiveness by monitoring changes in pain, swelling, and range of motion for a period of 24 weeks. Specifically, the study will measure changes in weight-bearing pain at 6 and 12 weeks post-dose, as well as changes in the rate and dose of prior medication, and the treatment's response rate.

Thirteen domestic clinical sites including Kyung Hee University Hospital at Gangdong will participate in the study. 

According to Shinpoong Pharmaceutical, SPM5002 rapidly improved the initial pain in non-clinical and phase 1/2 trials.

The treatment's frequency of administration is reduced to once every four months, making it a convenient option for patients with knee osteoarthritis. 

According to an official at Shinpoong, the treatment is expected to become a new treatment option once efficacy and safety are confirmed in the phase 3 clinical trials.