Samil Pharmaceutical announced the results of “OA-07”, a long-term Phase 3 clinical trial for “Lorecivivint”, a new knee osteoarthritis drug candidate from Biosplice Therapeutics, on the 13th of last month in San Diego, California, California. That was it announced on the 4th that an oral lecture was given at the American College of Rheumatology (ACR).Lorecivivint is a new drug candidate for the treatment of knee osteoarthritis being developed by Biosplice Therapeutics, a biotech company based in San Diego, USA. Samil Pharmaceutical secured domestic approval and exclusive distribution rights for Lorecivivint in March 2021.Lorecivivint is a CLK/DYRK kinase inhibitor and exerts its effectiveness via the Wnt signaling regulatory mechanism. Samil Pharmaceutical explained that it is being developed with the aim of developing the world’s first fundamental treatment for osteoarthritis, Disease-Modifying Osteoarthritis Drug (DMOAD).OA-07 is a long-term extension study conducted on 276 patients who completed the Phase 3 clinical trial of “OA-11” in the United States. It was designed to evaluate the potential for structural improvement when Lorecivivint was administered once annually for three years.In the first year of the OA-07 study (the second year including the OA-11 study), the test group was given 0.07 mg of lorecivivint and the control group was given placebo. In addition, in the second year of the OA-07 study (the third year including the OA-11 study), both the test and control groups were switched to the open-label administration group of Lorecivivint 0.07 mg. While the OA-07 study was ongoing, the results of the previous study, OA-11, were maintained in a double-blind condition.Clinical results showed that the 36-month medial knee joint gap width (mJSW) of the test group receiving 0.07 mg of Lorecivivint three times a year for three years was -0.06 mm, and the 24-month mJSW of the placebo control group was -0, 21mm. A difference in mJSW of 0.15 mm was observed between the two patient groups (p=0.045). Assuming that the control group was continuously administered placebo (36 months), the difference in mJSW between the test group and the placebo control group was 0.26 mm (p = 0.001).mJSW is a value that determines the degree of progression of knee osteoarthritis. The measurement is carried out using an x-ray. The smaller the mJSW, the more severe the progression of osteoarthritis is considered to be. On the other hand, it is assumed that the osteoarthritis improved with increasing mJSW.Specifically, this clinical trial found that Lorecivivint had greater benefit in patients with KL grade 2 whose knee osteoarthritis was comparatively less severe. Compared to baseline, mJSW increased by 0.17 mm in the 36-month treatment group, and there was a statistically significant increase compared to the last measurement time point (24 months) in the placebo control group before switching to the Lorecivivint treatment group (p = 0.012). Assuming that placebo was administered continuously for 36 months without switching to the Lorecivivint group, the difference in mJSW between the test group and the placebo control group was 0.35 mm (p = 0.003).Dr. Biosplice’s Yusuf Yazici, who announced the results of this phase 3 clinical trial, said: “These clinical results raise the possibility that repeated injections of lorcivivint can produce both structural changes and symptomatic benefits.” “We are pleased “To continue research into Lorcivivint as a treatment option for knee osteoarthritis,” he said.An official from Samil Pharmaceutical said: “It is significant that the long-term safety and efficacy of this clinical trial has been confirmed,” adding: “It is expected to be approved as a first-in-class drug in this class.” “We expect that “This is a significant new drug portfolio for Samil Pharmaceutical,” he said.
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