Osteal Therapeutics Announces First Subject Enrollment in Second Phase 2 Clinical Trial of VT-X7 Combination Product for Treatment of Periprosthetic Joint Infection
The second Phase 2 clinical trial known as APEX-2 will augment the VT-X7 safety and efficacy data collected in the APEX trial.
Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination therapies for musculoskeletal infections, announced today the first subject enrollment in its next Phase 2 study, known as APEX-2 (Abbreviated Protocol for Two Stage Exchange). APEX-2 is a multicenter, randomized controlled clinical trial of VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation in adults with periprosthetic joint infections (PJI) of the hip or knee). APEX-2 has a planned enrollment of 76 patients with a design similar to the previous Phase 2 study, APEX, which completed subject enrollment in November. APEX-2 is intended to augment the VT-X7 safety and efficacy evidence obtained from APEX.
The first APEX-2 subject was enrolled at the Cleveland Clinic in Cleveland, Ohio. Dr. Nicolas Piuzzi, MD, Cleveland Clinic Adult Reconstruction & Research (CCARR) Director and Principal Investigator for APEX-2, administered the treatment. Dr. Piuzzi noted, “PJI is the most serious and costly complication of total joint arthroplasty. Major improvements in the treatment of PJI have been elusive over the past two decades. VT-X7 has the potential to avoid the limitations we see in traditional systemic antibiotic therapies, and I look forward to building upon the valuable experience we obtained in the first APEX trial.”
“Enrolling the first APEX-2 subject less than three months after completing enrollment of the APEX trial is a major accomplishment for the Osteal team, and will allow us to capitalize on the enthusiasm we saw from our APEX clinical sites to rapidly enroll this second trial,” stated David Thompson, CEO of Osteal. “We’re confident that VT-X7 has the potential to be a highly effective tool for treatment of orthopedic infections. PJI is only the beginning of where this technology may benefit patients.”
The company expects complete 6-month follow-up data from APEX in June of 2023 and hopes to complete enrollment in APEX-2 in August.
About Periprosthetic Joint Infection (PJI)
Affecting over 40,000 people in the U.S annually, periprosthetic joint infection (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 under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options.
VT-X7 (VT-X7 spacer device, vancomycin hydrochloride and tobramycin sulfate) for irrigation 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 periprosthetic joint infection (PJI). VT-X7 is a seven-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these rare challenging infections. In a Phase 2 clinical study of vancomycin and tobramycin delivered by irrigation, 100% of patients were treated and received a new permanent joint prosthesis in seven days with 93% remaining infection free at one year. Osteal recently completed enrollment of the Phase 2 “APEX” clinical study, a randomized controlled trial of VT-X7 compared to the current standard of care for treatment of PJI, two-stage exchange arthroplasty. The US Food and Drug Administration granted VT-X7 orphan drug, fast track, and qualified infectious disease product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion dollar opportunity to dramatically improve outcomes for an unmet medical need.
About Osteal Therapeutics, Inc.
Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical 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 Phase 2 development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com
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