Osteal Therapeutics Granted FDA Breakthrough Designation for Joint Infection Therapy

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Osteal Therapeutics’ VT-X7, an investigational drug therapy for periprosthetic joint infection (PJI) in the hip and knee. The FDA previously granted VT-X7 Orphan Drug, Qualified Infectious Disease Product, and Fast Track designations.

The company also has completed enrollment in the APEX-2 clinical trial for VT-X7.
 
“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 PJI as a serious, life-threatening condition,” Osteal Therapeutics President/CEO David Thompson said. “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.”

VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation/VT-X7 irrigation system) is a 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 for treating these challenging infections. In a Phase 2 clinical study of VT-X7, all patients were treated and received a new permanent joint prosthesis in seven days with 93% remaining infection free at one year. This initial application of VT-X7 represents a first-of-its-kind, multibillion dollar opportunity to dramatically improve outcomes for a serious unmet medical need.
 
“We are pleased to see VT-X7 receive Breakthrough Therapy Designation from FDA. In this market where there are no FDA approved products for treatment of PJI, Osteal offers one of the most compelling advances in PJI treatment we have ever seen,” said Judson Cooper of Prism Ventures. “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 this lengthy period of limited mobility.”
 
Breakthrough Therapy designation was granted 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.
 
Affecting more than 40,000 people annually in the United States, 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. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate below 50% after 12 months.

Osteal Therapeutics is a privately held, clinical-stage company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7, is in late-stage clinical development to treat periprosthetic joint infections.