Osteal Therapeutics has raised $50m in Series D financing, as the orthopaedic infection treatment specialist turns its eyes to a regulatory submission for its lead candidate VT-X7.

Medtech giant Zimmer Biomet led the round with participation from existing investors, including Johnson & Johnson Innovation, among others.

The funds, which follow $23m raised in Series C financing in late 2023, will be used for a new drug application (NDA) to the US Food and Drug Administration (FDA) for VT-X7. Proceeds will also go towards advancing the US-based company’s musculoskeletal portfolio, according to a 5 June press release.

Osteal has designed VT-X7 for the treatment of periprosthetic joint infection. The condition is a complication of joint replacement surgery in which bacteria infiltrate the joint implant. This causes biofilms, a layer of microorganisms that are hard to treat.  

VT-X7 is a drug/device combination product, consisting of antibiotic drugs vancomycin hydrochloride and tobramycin sulfate for irrigation and the VT-X7 irrigation system. The therapy works by placing a spacer connected to an irrigation pump. Antibiotics are then administered into the joint space through the spacer for seven days of treatment.

Osteal says the product can deliver high antibiotic concentrations at the infection site and is effective against both gram-negative and gram-positive bacteria.

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The company’s candidate has breakthrough therapy, orphan drug, fast track, and qualified infectious disease product designations, indicating that the company is eligible for a range of benefits on expedited regulatory pathways.

VT-X7 recently demonstrated positive results in a Phase III trial, named APEX-2 (NCT05607030). The trial, which enrolled 76 patients scheduled for a two-stage exchange arthroplasty due to hip or knee periprosthetic joint infection, met its primary endpoint of treatment success after 180 days. The trial is expected to end in late 2024, at which point Osteal said it will seek FDA approval.

Osteal’s CEO David Thompson said: “This round of financing represents an inflection point in the company’s progress towards introducing VT-X7 to the market.”