Top-line results from Phase 1 study expected in second quarter of 2025
JUPITER, FL, USA I September 6, 2024 I Cytonics Corporation, a private biotechnology company developing biologic therapies for inflammatory musculoskeletal conditions, today announced completion of enrollment for their Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protease inhibitor, as a putative disease-modifying therapy for osteoarthritis (OA). This first-in-human clinical trial is a multi-center, 6-month, double-blind RCT (n=22, randomized 1:1 between treatment and placebo groups) evaluating the safety and efficacy of CYT-108 in patients with unilateral, mild-to-moderate, primary OA of the knee. The primary safety endpoints will measure CYT-108’s tolerability when delivered via intra-articular injection directly into afflicted joints. The secondary efficacy endpoints will assess improvement in self-reported pain and mobility in the treated joint, and an exploratory endpoint will quantify peptide fragments found in blood serum as a biomarker for cartilage degradation. To date, no drug-related adverse events have been reported and CYT-108 appears well-tolerated in all patients.
“We are thrilled to have completed enrollment of all 22 patients across our three clinical sites in Australia, beating our recruitment forecast by more than a month. This will expedite the Phase 1 clinical study report and our IND filing with the FDA in 2025, bringing us one step closer to developing the first and only disease-modifying therapy for osteoarthritis. We are thoroughly impressed by the recruitment efficiency of our clinical sites and look forward to continuing working with these researchers and clinicians as we advance into Phase 2.”
~ Joey Bose, President & CEO, Cytonics Corp.
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.
SOURCE: Cytonics
Post Views: 693
Top-line results from Phase 1 study expected in second quarter of 2025
JUPITER, FL, USA I September 6, 2024 I Cytonics Corporation, a private biotechnology company developing biologic therapies for inflammatory musculoskeletal conditions, today announced completion of enrollment for their Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protease inhibitor, as a putative disease-modifying therapy for osteoarthritis (OA). This first-in-human clinical trial is a multi-center, 6-month, double-blind RCT (n=22, randomized 1:1 between treatment and placebo groups) evaluating the safety and efficacy of CYT-108 in patients with unilateral, mild-to-moderate, primary OA of the knee. The primary safety endpoints will measure CYT-108’s tolerability when delivered via intra-articular injection directly into afflicted joints. The secondary efficacy endpoints will assess improvement in self-reported pain and mobility in the treated joint, and an exploratory endpoint will quantify peptide fragments found in blood serum as a biomarker for cartilage degradation. To date, no drug-related adverse events have been reported and CYT-108 appears well-tolerated in all patients.
“We are thrilled to have completed enrollment of all 22 patients across our three clinical sites in Australia, beating our recruitment forecast by more than a month. This will expedite the Phase 1 clinical study report and our IND filing with the FDA in 2025, bringing us one step closer to developing the first and only disease-modifying therapy for osteoarthritis. We are thoroughly impressed by the recruitment efficiency of our clinical sites and look forward to continuing working with these researchers and clinicians as we advance into Phase 2.”
~ Joey Bose, President & CEO, Cytonics Corp.
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.
SOURCE: Cytonics
Post Views: 693
