A seven-day treatment for periprosthetic joint infections (PJI) has just attracted $23 million in series C funding—bringing the total raised to date for this truly novel approach to nearly $65 million.
The investors are among the top venture and private equity firms in the United States—Gideon Strategic Partners, Asteroid Partners and returning investors Johnson and Johnson Development Corp., HM Capital, Prism Ventures and Medvest Capital
The new drug therapy for periprosthetic joint infections is VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation/VT-X7 irrigation system).
It is a drug/device combination product which delivers vancomycin and tobramycin, well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. The drug is delivered by irrigation and is a seven-day therapy.
According to the company bringing VT-X7 through the regulatory gauntlet, Dallas, Texas-based Osteal Therapeutics, Inc., 100% of patients recently treated as part of a clinical study received a new permanent joint prosthesis in seven days with 93% remaining infection free at one year.
FDA Orphan Drug AND Fast Track Status
The U.S. Food and Drug Administration (FDA) granted VT-X7 orphan drug, fast track, and qualified infectious disease product designations.
Osteal Therapeutics is nearing full enrollment of its second multicenter, randomized controlled clinical trial of VT-X7. The study, which carries the moniker “APEX-2”, builds upon an early Phase 2 study that met its primary endpoint earlier in 2023. Both studies were designed in consultation with the FDA following the agency’s decision to designate VT-X7 an orphan drug and qualified infectious disease product.
Osteal will formally apply for New Drug Application (NDA) approval once the full data from APEX-2 is collected and providing that endpoints are met.
“This is a very exciting time at Osteal as we expect to achieve a number of critical value-creating milestones in the coming months,” said President and Chief Executive Officer David Thompson. “This capital raise places Osteal in an excellent position to continue our progress with the VT-X7 program, while also leveraging our technical and scientific expertise to strategically expand our pipeline.”
Investor Comments
Asteroid Partners, an investor, chimed in.
“Today, hip and knee replacements are extremely common. An aging population that is seeking to stay active will drive a roughly three-fold increase in annual procedures between now and 2040. PJIs, while rare, closely track the number of primary and revision joint replacements. The current standard of care for treatment of PJI is associated with significant morbidity, risk of early death and reduced quality of life, driving both the clinical community and regulators to search for better treatment options. Osteal is addressing this significant unmet medical need with a highly novel approach,” said Martin Sands of Asteroid Partners.
“I am impressed with the progress this team has made, especially with their clinical program. What I find the most compelling is that when I speak to clinicians, they universally describe the serious unmet need in PJI treatment and quickly understand the potential value of VT-X7. They recognize this solution affords the possibility to both save and change lives,” said Steven Sands, of Asteroid Partners. “I believe Osteal’s therapeutic platform will dramatically improve quality of life and outcomes for patients with serious orthopedic infections. I look forward to supporting the team to achieve multiple key milestones over the next 18 months.”
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.
For more information, please visit: www.ostealtx.com
