DALLAS – August 5, 2024 (GLOBE NEWSWIRE) – Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, presented positive results from the two APEX (Abbreviated Protocol for Two Stage Exchange) randomized controlled clinical trials of the VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) in patients with periprosthetic joint infections (“PJI”) of the hip or knee. Results were presented by Dr. Nicolas S. Piuzzi, MD, of the Cleveland Clinic Foundation in Cleveland, Ohio, at the 34th Annual Musculoskeletal Infection Society meeting.
The two APEX clinical trials, consisting of more than 150 patients, demonstrated VT-X7 met the six-month efficacy endpoint, achieving a statistically significant improvement in overall success with a net treatment effect of 41% in patients treated with VT-X7 versus standard of care, two-stage exchange arthroplasty. All VT-X7 patients received a permanent implant at Stage 2 versus 75% of control arm patients. The median time to Stage 2 surgery was also significantly shorter, at 7 days, compared to 102 days in the control arm.
“The six-month results of the APEX clinical trials are highly encouraging. PJI is a debilitating condition associated with morbidity and mortality, and VT-X7 is a groundbreaking approach to its treatment. This therapy has the potential to transform current, highly variable treatment outcomes by offering a very effective solution in a considerably shorter timeframe. This is very promising from both the patients’ and surgeons’ perspectives, with the potential to significantly enhance both quality of life and treatment success.” says Dr. Piuzzi, Principal Investigator for the APEX-2 clinical study.
Periprosthetic Joint Infection (PJI)
Affecting over 40,000 people in the U.S. 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. 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 KIT
VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, two well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, 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 a serious unmet medical need in PJI.
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 KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com