Osteal Therapeutics Reports Positive Six-Month APEX Trial Results at 34th Musculoskeletal Infection Society Meeting

Osteal Therapeutics, Inc., a clinical-stage biopharmaceutical firm, recently unveiled promising results from its APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials, evaluating the VT-X7 KIT in patients suffering from periprosthetic joint infections (PJI) of the hip or knee. These results were presented by Dr. Nicolas S. Piuzzi from the Cleveland Clinic Foundation at the 34th Annual Musculoskeletal Infection Society meeting.

The APEX trials involved over 150 patients and assessed the efficacy of the VT-X7 KIT, which combines vancomycin hydrochloride and tobramycin sulfate in an irrigation system. The trials demonstrated that VT-X7 achieved a statistically significant improvement in overall success compared to the standard two-stage exchange arthroplasty. Specifically, the VT-X7 group exhibited a net treatment effect of 41% over the control group. Additionally, all patients in the VT-X7 group received a permanent implant by the second stage of treatment, compared to just 75% in the control group. The median time to reach the second stage of surgery was significantly shorter for the VT-X7 group, at 7 days, compared to 102 days for the control group.

Dr. Piuzzi emphasized the significance of these findings, noting that PJI is a debilitating condition often linked with high morbidity and mortality rates. The VT-X7 KIT offers a groundbreaking approach that could potentially transform the current variable treatment outcomes, providing a highly effective solution in a much shorter timeframe. This, in turn, could significantly improve both the quality of life for patients and the overall success of treatment.

Periprosthetic Joint Infection (PJI) is a rare but severe complication that affects over 40,000 individuals annually in the U.S. It occurs when pathogenic bacteria colonize a joint prosthesis, forming biofilms that are extremely difficult to eradicate. These infections often require lengthy, invasive, and costly treatments, which are frequently unsuccessful, leading to high rates of permanent disability and premature death. Current treatments, such as the two-stage exchange arthroplasty, have an average success rate of less than 50% after 12 months and typically take around 16 weeks to complete. This underscores the urgent need for faster and more effective treatment options.

The VT-X7 KIT represents a novel drug/device combination designed to deliver high concentrations of vancomycin and tobramycin directly to the infected joint and surrounding tissues. This 7-day therapy aims to meet the clinical need for a quick and reliable treatment for PJI. Clinical studies have shown that VT-X7 allowed 100% of treated patients to receive a new permanent joint prosthesis within seven days, with over 90% remaining infection-free after one year. The U.S. Food and Drug Administration has granted VT-X7 several designations, including Breakthrough Therapy, Orphan Drug, Fast Track, and Qualified Infectious Disease Product. This innovation represents a significant opportunity to improve outcomes for patients suffering from PJI.

Osteal Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on developing new musculoskeletal therapeutics aimed at treating orthopedic infections. The company leverages the efficacy of locally delivered antimicrobials to target bacterial biofilms responsible for these infections while minimizing off-target effects. Osteal's development strategy involves using approved drugs with established safety profiles for new local delivery routes. The company's lead product, VT-X7 KIT, is in late-stage development for treating periprosthetic joint infections, a serious complication following joint replacement surgeries.