David Hunter, MBBS, PhD: Phase 3 Findings on Repeat TLC599 Injection for Osteoarthritis of the Knee

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This discussion with Dr. Hunter covered the takeaways from his team’s phase 3 findings on treatment of osteoarthritis of the knee.

In his interview with the HCPLive editorial team, David Hunter, MBBS, PhD, described his team’s findings on injection of TLC599 for patients with osteoarthritis of the knee.1

Hunter’s research was presented at the American College of Rheumatology 2023 Convergence in San Diego, California.

Hunter serves as both co-Director of Sydney Musculoskeletal Health and as the head of the osteoarthritis team at the Kolling Institute. He is recognized for his work as an expert in osteoarthritis.

“This was a randomized control trial conducted both in the US and in Australia, where 504 people were recruited, and they were randomized into one of 3 groups,” Hunter said. “The 3 groups were a placebo, which was a saline injection. Second group was dexamethasone, which is a commonly used corticosteroid injection. And the third group was into what's called TLC599, which is a liposomal preparation of dexamethasone to optimize sustained release.”

The TLC599 injection was shown to benefit patients versus placebo in average daily pain (ADP) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain following a single injection sustained to 24 weeks. The next injection at Week 24 was shown to further benefit up to 52 weeks.

“These people were followed for 6 months to ascertain improvements in pain function and then at the end of 6 months, they were also offered an opportunity to participate in a longer term reinjection study that was then followed out through a 12 month period in total,” Hunter said. “This is an injection broadly consistent with other intra-articular injections, so an injection into the joint. And the main constituent ingredient here is dexamethasone, which is a commonly used corticosteroid injection used for the treatment of osteoarthritis.”

He noted that the difference with TLC599 is that it is formulated in a way where it is a liposomal preparation to facilitate sustained release.

“Typical dexamethasone, or other steroid injections for that matter, into the knee might have a duration of relief compared to placebo of 2 - 4 weeks on average,” Hunter said. “The intent being, though, that for this chronic disease, we'd like to have pain relief that goes for a longer period of time. The benefit of the preparation is that it allows for that sustained release.”

For further information, view the full interview segment posted above.

The quotes contained in this summary were edited for clarity.

References

  1. Spencer-Green G, Hunter D, Schnitzer T, Shih S, Tai T, Kao C, Huang S. A Phase 3 Study of Repeat Injection of TLC599 in Osteoarthritis of the Knee: Benefits to 52 Weeks [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/a-phase-3-study-of-repeat-injection-of-tlc599-in-osteoarthritis-of-the-knee-benefits-to-52-weeks/. Accessed November 12, 2023.
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