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Osteal Therapeutics' VT-X7 Gets FDA Breakthrough Designation, Completes APEX-2 Trial Enrollment

Wednesday, December 06, 2023

Osteal Therapeutics has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for VT-X7, an investigational drug therapy targeting periprosthetic joint infection (PJI) in the hip and knee. This designation expedites the development and commercialization of drugs that show promise in significantly improving the current standard of care for serious conditions. VT-X7 had previously received Orphan Drug, Qualified Infectious Disease Product, and Fast Track designations from the FDA. The company has also completed enrollment in APEX-2, a pivotal clinical trial for VT-X7.

David Thompson, President and CEO of Osteal, expressed the significance of the Breakthrough Therapy Designation, highlighting the FDA's acknowledgment of VT-X7's potential to address PJI, a life-threatening condition. The designation accelerates the pathway to providing a better treatment option for patients and healthcare providers.

Judson Cooper of Prism Ventures emphasized the groundbreaking nature of VT-X7 in PJI treatment, particularly its potential to shorten the traditional two-stage exchange arthroplasty process, offering patients a quicker return to normal life with reduced morbidity and mortality.

The Breakthrough Therapy Designation was granted based on positive results from the APEX Phase 2b clinical trial, indicating VT-X7's safety and efficacy. The FDA's Breakthrough Therapy program aims to fast-track the development of drugs for serious or life-threatening conditions that demonstrate substantial improvement over existing therapies.

PJI is a rare and severe complication affecting over 40,000 people annually in the U.S., arising from joint replacement surgery. Traditional treatments, such as two-stage exchange arthroplasty, have limited success rates and long durations, underscoring the urgent need for more efficient and effective options.

VT-X7, a novel drug/device combination, delivers vancomycin and tobramycin directly to the joint space to treat PJI. In a Phase 2 study, VT-X7 achieved a 100% treatment rate with patients receiving a new permanent joint prosthesis in seven days, and 93% remained infection-free at one year. The multiple FDA designations, including Breakthrough Therapy, highlight the potential of VT-X7 to address the substantial unmet medical need associated with PJI.



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