Prosthetic joint infection therapy gets breakthrough designation from FDA
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Key takeaways:
- The FDA granted Osteal’s VT-X7 breakthrough therapy designation based on recent trial data.
- The investigational drug-device combo is designed to deliver antibiotics to the joint space and surrounding tissue.
The FDA designated a drug-device combination for periprosthetic joint infection in hip and knee replacement patients as a breakthrough therapy, which may accelerate its approval, the manufacturer said.
Osteal Therapeutics’ VT-X7 previously was granted orphan drug, qualified infectious disease product and fast-track designations by the FDA based on early clinical evidence that it can improve care for the potentially disabling or life-threatening infections, the company said in a press release.
VT-X7 is designed to deliver therapeutic concentrations of the broad-spectrum antibiotics vancomycin and tobramycin to the joint space and surrounding tissue to treat a prosthetic joint infection, according to Osteal. The antibiotics are delivered through an irrigation pump and a spacer placed inside the patient after the infected joint prosthesis is removed.
The breakthrough designation was granted based on data from Osteal’s phase 2b APEX clinical trial, which ended in February.
Periprosthetic joint infection (PJI) affects about 40,000 people in the United States each year — between 1% and 2.5% of patients, depending on the joint replacement procedure — and is often difficult to treat if biofilms have formed on prosthetics, protecting pathogens from the immune system.
Osteal President and CEO David Thompson said the designation “reflects FDA’s recognition of VT-X7s potential in the treatment of PJI as a serious, life-threatening condition.”
“Patients and providers desperately need a better option for treatment PJI,” Thompson said in the release. “This designation supports the potential for VT-X7 to transform PJI treatment and puts us on an accelerated pathway to addressing this need.”
According to Osteal, 100% of participants in the phase 2 APEX trial were treated with VT-X7 and received a new permanent joint prosthesis 7 days after therapy. In all, 93% did not develop an infection during the 12 months after surgery.
Earlier this year, Osteal also started enrollment for its follow-up APEX-2 phase 2 clinical trial, with results from that study expected sometime in late 2024.
References:
- A second trial of the abbreviated protocol two-stage exchange (APEX-2). https://clinicaltrials.gov/study/NCT05607030. Last updated Aug. 21, 2023. Accessed Dec. 5, 2023.
- Abbreviated protocol for two-stage exchange (APEX). https://clinicaltrials.gov/study/NCT04662632. Last updated March 22, 2023. Accessed Dec. 5, 2023.
- Osteal Therapeutics’ VT-X7 received FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee and completes enrollment of the pivotal APEX-2 trial. https://www.globenewswire.com/en/news-release/2023/12/05/2790778/0/en/Osteal-Therapeutics-VT-X7-Receives-FDA-s-Breakthrough-Therapy-Designation-for-the-treatment-of-periprosthetic-joint-infection-of-the-hip-and-knee-and-completes-enrollment-of-the-pi.html. Published Dec. 6, 2023. Accessed Dec. 6, 2023.
- Zardi EM, et al. J Infect Public Health. 2020;doi:10.1016/j.jiph.2020.09.006.
- Ahmed SS, et al. Bone Joint Res. 2019;doi:10.1302/2046-3578.812.BJR-2019-0340.
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