Osteal Therapeutics’ VT-X7 Receives FDA’s Breakthrough Therapy Designation for the treatment of periprosthetic joint infection of the hip and knee and completes enrollment of the pivotal APEX-2 trial
05 Dec 2023
Fast TrackOrphan DrugPhase 2Qualified Infectious Disease ProductBreakthrough Therapy
Osteal Therapeutics’ VT-X7 Receives FDA’s Breakthrough Therapy Designation for the treatment of periprosthetic joint infection of the hip and knee and completes enrollment of the pivotal APEX-2 trial
Breakthrough Therapy Designation for VT-X7 builds upon previous Orphan Drug, Qualified Infectious Disease Product (QIDP) and Fast Track Designations
DALLAS, Dec. 05, 2023 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for VT-X7, Osteal Therapeutics’ (“Osteal’s”) investigational drug therapy for periprosthetic joint infection (“PJI”) of the hip and knee. Breakthrough Therapy Designation helps to accelerate commercialization of new drugs for the treatment of serious conditions when early clinical evidence shows the potential to provide a significant improvement of current standard of care. Previously, FDA granted VT-X7 Orphan Drug, Qualified Infectious Disease Product and Fast Track designations. The company also announced completion of enrollment in APEX-2 the pivotal 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,” said David Thompson, President and Chief Executive Officer. “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.”
“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 (NCT04662632), 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 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.
About VT-X7
VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation/VT-X7 irrigation system) 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 PJI. VT-X7 is a seven-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In a Phase 2 clinical study of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with 93% remaining infection free at one year. The US FDA granted VT-X7 Breakthrough Therapy, orphan drug, fast track, priority review 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.
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 late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com
Media Contacts:
Todd Saunders
Vice President of Marketing
Email: info@ostealtx.com
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