osteal therapeutics, inc.(hereinafter referred to as.)"osteal") is a clinical-stage biopharmaceutical company focused on developing novel combinations of orthopedic infections, and recently announced the closing of an oversubscribed $23 million Series C equity funding round. The funding gives Osteal ample funding to submit a New Drug Application (NDA) to the FDA and expedite preparations for the commercial launch of its lead* VT-X7 for periprosthetic joint infection (PJI).
The round was led by Asteroid Partners, with participation from new investors Gideon Strategic Partners and existing investors John and Johnson Development Corporation (JJDC), HM Capital, Prism Ventures and Medvest Capital.
The Company is nearing the completion of registration for APEX-2, a multicenter randomized controlled clinical trial of VT-X7. The purpose of the APEX-2 is to build on the safety and efficacy evidence obtained with APEX-1, a similarly designed Phase 2 study that successfully met its primary endpoint earlier this year. Both studies were designed in consultation with the U.S. Food and Drug Administration after receiving orphan drug and qualified infectious disease product designation. The Company expects to seek NDA approval once APEX-2 has reached the program endpoint.
Osteal President and CEO D**id Thompson said:"This is a very exciting time as we are on track to achieve a series of important milestones in creating value in the coming months. This capital raise allows Osteal to continue advancing the VT-X7 project while strategically expanding our product line with our technical and scientific expertise. ”
About periprosthetic joint infection (PJI).
Periprosthetic joint infection is a rare and potentially devastating complication of joint replacement surgery, affecting more than 40,000 people in the United States each year, and pathogenic bacteria colonize the joint prosthesis, forming biofilm structures that are difficult to remove. Resolution of biofilm infections is challenging, prolonged, invasive, and expensive**, but often unsuccessful, leading to a high incidence of permanent disability and early death. Recent retrospective analyses have shown that the current standard for PJI is a two-stage exchange arthroplasty, which takes an average of 16 weeks, with a success rate of less than 50% after 12 months, highlighting the unmet need for faster, more effective** protocols.
About VT-X7
VT-X7 (Vanticomycin Hydrochloride and Tobramycin Sulfate for Lavage VT-X7 Lavage System) is a novel drug-device combination product designed to deliver ** concentrations of vancomycin and tobramycin (a recognized broad-spectrum antibiotic) directly into the joint space and surrounding tissues to **PJI. The seven-day course of VT-X7 is designed to address the unmet clinical need for rapid, reliable** these intractable infections. In a phase II clinical study in which vancomycin and tobramycin were administered by perfusion, 100% of patients received ** and received a new permanent joint prosthesis within seven days, and 93% did not develop an infection after one year. The U.S. Food and Drug Administration granted VT-X7 orphan drug, fast track, and qualified infectious disease product designation. The first application of the VT-X7 represents a first-of-its-kind, multi-billion dollar opportunity to significantly improve outcomes with severely unmet medical needs.
About Osteal Therapeutics, Inc
Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company focused on developing novel musculoskeletal drugs to develop orthopedic infections and their consequences. The Company utilizes a concentrated antimicrobial** bacterial biofilm that is commonly caused by musculoskeletal infections when administered locally, while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy to designate approved drugs with long-term safety and efficacy as drug candidates for new topical routes of administration. The Company's lead drug candidate, VT-X7, is in Phase 2 development for a serious complication of joint replacement surgery – periprosthetic infection.