Osteal Therapeutics Secures $50M in Series D Financing

Osteal Therapeutics Inc. has completed an oversubscribed $50 million Series D preferred stock equity financing led by Zimmer Biomet. Other investors supporting Osteal Therapeutics included Johnson & Johnson Innovation – JJDC Inc., Gideon Strategic Partners, and HM Capital.

As part of the financing, a Zimmer Biomet representative will join Osteal’s Board of Directors.
 
Osteal Therapeutics will use the money to advance the development of its therapies, including the submission of a New Drug Application (NDA) for, and accelerated commercial launch of, VT-X7 for the treating hip and knee periprosthetic joint infection (PJI). VT-X7 has been studied in two multicenter, randomized, controlled trials, APEX and APEX-2, the latter of which met its primary endpoint and will be completed late this year. The study builds upon the safety and efficacy evidence obtained from APEX, a similarly designed clinical study that successfully met its primary endpoint last year. Both studies were designed in close consultation with the U.S. Food and Drug Administration (FDA), which previously granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track, and Qualified Infectious Disease Product designations. The company expects to seek FDA approval upon completion of APEX-2.
 
“This round of financing represents an inflection point in the company’s progress towards introducing VT-X7 to the market,” Osteal Therapeutics Chairman/CEO David Thompson said. “From the beginning, Osteal has been extremely fortunate to have the support of a group of financial and strategic partners who share our vision and recognize the impact our programs will have on patient care. I am delighted to welcome Zimmer Biomet as a partner and look forward to working closely with their team.”
 
Affecting more than 40,000 people annually in the United States, 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 the current gold standard for treating PJI, two-stage exchange arthroplasty, takes 16 weeks on average and has a success rate under 50% after 12 months.

VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation/VT-X7 irrigation system) is a drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin—broad-spectrum antibiotics—directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a seven-day therapy that aims to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. 
 
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.