Biosplice announces data from osteoarthritis clinical trial – and the initiation of new phase 3 trial

Unique interim X-ray results from an ongoing long-term extension study suggest structure-modifying benefit of repeat injections of lorecivivint.

Biosplice Therapeutics, a clinical-stage biotech company pioneering first-in-class small molecule therapeutics, has announced potential structure-modifying highlights from an ongoing long-term extension study for its knee osteoarthritis (OA) drug candidate, lorecivivint.

Results from the study continue to support the potential efficacy of multiple injections of lorecivivint in delaying structural progression and providing symptomatic benefits.

Longevity.Technology: Knee osteoarthritis is a degenerative joint disease that affects the knee joint and is characterised by the breakdown of cartilage, leading to pain, swelling and difficulty with movement that is not only debilitating, but affects quality of life. It is a common condition that is often seen in older adults, although it can also affect younger individuals as a result of injury or genetics.

Aging is the major risk factor for osteoarthritis, but other factors for developing knee osteoarthritis include being overweight, having a family history of the disease and participating in high-impact sports or activities.

The global cost of knee osteoarthritis is significant, with estimates suggesting that it is one of the leading causes of disability worldwide. It is a major contributor to lost productivity and absenteeism in the workforce, and the cost of treatment and management can be high. Treatment options for knee osteoarthritis include medications, physical therapy, and in severe cases, joint replacement surgery, so the need for novel therapies is significant.

“We believe these unique data highlight lorecivivint’s promise to potentially provide structural benefit to the millions of patients suffering from osteoarthritis,” commented Biosplice Chief Medical Officer, Yusuf Yazici, MD.

“These latest interim results from OA-07 build upon our robust body of existing evidence, suggesting that repeat injections of LOR could provide patients and physicians with both structure-modifying and symptomatic benefits. We recently initiated our phase 3 OA-21 clinical trial and are enrolling subjects. We are excited to continue to investigate LOR as a treatment option for knee OA.”

OA-07 is a long-term extension trial, which enrolled patients who completed OA-11, a previous 12-month study. The primary efficacy objective of OA-07 is to measure the disease-modifying potential of lorecivivint over multiple years and injections. During the first year of the OA-07 study, patients and investigators remained blinded and patients received injections of LOR on an annual basis, allowing Biosplice to capture both long-term and repeat-injection data for safety, efficacy and medial joint space width (mJSW).

Previously presented at the American Conference of Rheumatology Annual Meeting in November 2022, data for the first year of OA-07 show clinically significant improvement in mJSW relative to placebo, with an effect size of 0.13 mm in KL2 subjects. Moreover, OA-07 data demonstrate a significant improvement in an arthritis pain and function indices.

In subjects who have completed their second annual visit and who previously received LOR in OA-11 and OA-07 there continues to be an increase in their mJSW versus baseline. These subjects have now received three injections of LOR over three years. Among those subjects who have completed their second annual OA-07 visit and who previously had received placebo, the introduction of LOR appears to have arrested their decline in mJSW.

Consistent with the clinical program to date, LOR continued to appear safe and well-tolerated in the recently completed studies, with no safety signals with repeat injections.
The OA-21 phase 3 clinical trial is designed as a 16-week study with a primary endpoint of Pain NRS at 12 weeks. This study will further evaluate the impact of LOR on knee osteoarthritis pain and function and has been designed to enroll the less structurally damaged patient population that has shown consistent responses across Biosplice’s phase 2 and phase 3 clinical trials.