RARE Daily

FDA Grants Osteal Breakthrough Therapy Designation for Treatment for Periprostehtic Joint Infection

December 5, 2023

Rare Daily Staff

The U.S. Food and Drug Administration granted Breakthrough Therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint infection of the hip and knee.

Periprosthetic Joint Infection (PJI) affects more than 40,000 people in the United States annually. PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis forming difficult to remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death.

VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation/VT-X7 irrigation system) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a seven-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections.

In a phase 2 clinical study of VT-X7, 100 percent of patients were treated and received a new permanent joint prosthesis in seven days with 93 percent remaining infection free at one year. By virtually eliminating the interstage period associated with traditional two-stage exchange arthroplasty, VT-X7 could put patients on the path to normal life sooner without the morbidity and mortality associated with the current standard of care.

FDA granted Breakthrough Therapy designation based on results from APEX, a phase 2b, prospective, multi-center, randomized controlled clinical trial evaluating the safety and efficacy of VT-X7. FDA’s Breakthrough Therapy program is designed to expedite development review of drugs intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies.

“Receiving Breakthrough Therapy designation from FDA is a significant achievement for the company and reflects FDA’s recognition of VT-X7’s potential in the treatment of periprosthetic joint infection (PJI) as a serious, life-threatening condition,” said David Thompson, president and CEO of Osteal Therapeutics. “Patients and providers desperately need a better option for treating PJI. This designation supports the potential for VT-X7 to transform PJI treatment and puts us on an accelerated pathway to addressing this need.”

Photo: David Thompson, president and CEO of Osteal Therapeutics

 

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