- Topline results expected by end of Q2 2025 –
- Phase 1 enrolled 22 patients to examine the safety profile in patients suffering from primary osteoarthritis of the knee -
- CYT-108 is a recombinant protease inhibitor therapy with potential disease-modifying effects -
JUPITER, Fla., April 1, 2025 /PRNewswire/ -- Cytonics, an early-stage biopharmaceutical company developing therapies for osteoarthritis, today announced that the last patient has completed their last visit in the Company’s first-in-human clinical trial of CYT-108, a novel recombinant protein variant of an endogenous, broad-spectrum protease inhibitor, delivered twice (90 days apart) via intra-articular injection into arthritic knees.
“We are deeply grateful to the patients, physicians, and research staff who made this study possible,” said Joey Bose, President and CEO of Cytonics. “Reaching the last patient visit in our first-in-human trial of CYT-108 is a major milestone—not only for our company, but for the broader osteoarthritis community. Their participation brings us one step closer to validating a therapy that, if successful, may finally address the root molecular cause of OA. With Phase 1 now complete, our team is focused on cleaning and locking the database, and preparing for submission of our IND to the FDA later this year.”
“This is an exciting moment for Cytonics,” added Dr. Gaetano Scuderi, Founder and Chief Medical Officer. “Over the past 30 years, the search for a disease-modifying OA therapy has been marked by failure. CYT-108 represents a novel approach—engineered for multi-targeted inhibition of the proteases responsible for cartilage degradation. We believe this dual specificity and broad-spectrum activity sets CYT-108 apart from historical attempts, and may offer a meaningful step forward in how osteoarthritis is treated. We look forward to sharing our findings as we progress toward Phase 2 clinical trials.”
About CYT-108
CYT-108 is a recombinant variant of the endogenous alpha-2-macroglobulin (A2M) blood serum protein. The “bait” region of the protein, which serves as a substrate for proteases, was engineered to increase its affinity for specific proteases that are known to play a significant role in the molecular pathogenesis of osteoarthritis. The combination of both highly specific and broad-spectrum protease inhibition activity of CYT-108 differentiates this novel biologic from other attempts to develop small molecule inhibitors that target a single proteases, positioning CYT-108 as an ideal disease-modifying candidate for osteoarthritis. The development of CYT-108 is predicated on the success of Cytonics’ first-generation therapy, the Autologous Protease Inhibitor Concentrate (APIC) system, which is a 510(k) medical device that selectively enriches autologous A2M for intra-articular injection into joints containing articular cartilage (knee, shoulder, spine, hip, etc.). The clinical and commercial success of APIC uniquely de-risks the development of CYT-108 because it is already understood that high concentrations of A2M can be introduced into arthritic joints without significant side effects, and the treatment has achieved clinical and commercial success since it was first cleared by the FDA as a 510(k) device and sold in 2015.
About Cytonics Corp.
Cytonics, founded in 2006, is a private research and development company focused on developing molecular diagnostics and therapeutics for chronic musculoskeletal diseases such as osteoarthritis. The company’s flagship product was a diagnostic test (the Fibronectin-Aggrecan Complex Test, FACT) which helps identify the source of joint pain and assists physicians in determining the most appropriate course of treatment. Cytonics then developed the Autologous Platelet-Integrated Concentrate (APIC) system which concentrates a therapeutic blood protein, A2M, from patients’ own blood and injects the A2M-rich concentrate into damaged joints. APIC has been used to treat over 8,000 patients nationwide, saving thousands of patients from invasive joint replacement surgeries. The company has raised over $25M in private funding and was awarded $1.8M in grants from the NIH to pursue their innovative research. The company is currently pursuing Phase 1 clinical studies for their lead drug candidate, CYT-108, a recombinant variant of the endogenous alpha-2-macroglobuling protease inhibitor. If approved, CYT-108 may be the first and only disease-modifying therapy for osteoarthritis.
Forward Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the progress of and plans related to the Company’s product candidates, clinical studies and preclinical research and development programs, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s expectations regarding progress and timelines. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission (https://www.sec.gov/edgar/browse/?CIK=0001421744), including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Cytonics Corporation is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
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SOURCE Cytonics Corporation
