DALLAS, Sept. 21, 2023 (GLOBE NEWSWIRE) — Osteal Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a new category of combination therapies for orthopedic infections, announced today the completion of an oversubscribed $23 million Series C equity financing. The proceeds leave Osteal well-funded to submit its New Drug Application (NDA) submission to FDA and accelerate preparation for commercial launch of VT-X7, its lead therapy for the treatment of periprosthetic joint infection (PJI).
Asteroid Partners led the round joined by new investor Gideon Strategic Partners and returning investors Johnson and Johnson Development Corporation (JJDC), HM Capital, Prism Ventures and Medvest Capital. In conjunction with the financing, Martin Sands and Steven Sands of Asteroid Partners will join the board as board member and observer respectively. Both will provide valuable insights as Osteal continues to pursue multiple growth paths.
The company is rapidly approaching completion of enrollment in APEX-2, a multicenter, randomized controlled clinical trial of VT-X7. APEX-2 is intended to build upon the safety and efficacy evidence obtained from 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 FDA following receipt of orphan drug and qualified infectious disease product designations. The company expects to seek NDA approval once APEX-2 reaches its planned endpoints.
“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 David Thompson, President and Chief Executive Officer. “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.”
“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.”
About 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.
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 vancomycin and tobramycin delivered by irrigation, 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 Food and Drug Administration granted VT-X7 orphan drug, fast track, 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.
About Osteal Therapeutics, Inc.
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 Phase 2 development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com
