TPX-100 injection may ‘reduce or eliminate’ need for knee replacement in osteoarthritis
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TPX-100, a novel intra-articular injection, yielded strong improvements in bone shape change and function that may ultimately minimize the need for knee replacement, according to a speaker at the 2022 OARSI World Congress.
Dawn McGuire, MD, of OrthoTrophix, discussed the importance of bone shape change as a potential predictor of radiographic OA. She added that femoral bone shape as assessed by B-score could be a significant predictor of outcomes in this disease.
“It is a reasonable hypothesis that slowing B-score increase could delay or eliminate the need for total knee replacement,” she said.
McGuire presented a case study involving 78 patients treated with TPX-100 (OrthoTrophix), a 23-amino acid peptide that can be administered by intra-articular injection in knee OA. The drug targets bone shape change and may lead to associated improvements in pain and function, according to McGuire.
The phase 2 study examined benefits in these parameters at 6 and 12 months of follow up. “We wanted to look at the relationship of bone shape change to pain and function,” McGuire said.
Injections were administered 4 weeks apart, with patients treated with the study drug in one knee and saline in the other.
“All subjects had mild to severe osteoarthritis in both knees,” McGuire said.
Results demonstrated that TPX-100 reduced pathological femoral bone shape change, compared with placebo (P = .03).
“There was a fairly marked difference between treatment and control groups,” McGuire said.
In addition, the treated knees at 60-month follow-up demonstrated a trajectory of B-score improvement that was similar to knees without OA. This effect was slightly reduced by 12 months.
Other findings showed that the study drug was associated with a 26% improvement from baseline in WOMAC function at 12 months (P = .01).
The injection was effective in achieving functional improvement in patients from all OA disease severity cohorts (P = .05), including those with high baseline B scores. “Importantly, among the most severely affected knees, there is an effect of TPX-100,” McGuire said.
Additionally, TPX-100 may ultimately represent a significant cost savings in OA if the injection can, in fact, improve both bone shape change and function, according to McGuire. “Treatment-related improvements in knee function and delay of progression of pathological bone shape change may reasonably be expected to reduce or eliminate the need for total knee replacement and joint failure, with its burden of cost and potential complications,” she said.
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McGuire D. Improved WOMAC physical function is associated with slowed pathological bone shape change after TPX-11: Towards a surrogate marker for virtual knee replacement? Presented at: OARSI 2022 World Congress on Osteoarthritis; April 7-10; Berlin, Germany (virtual meeting).
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