Osteoarthritis Affects 600M People. We’re Making the Cure.
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Osteoarthritis (OA) is a degenerative disease that destroys the protective cartilage within joints, severely hindering mobility and causing debilitating pain. OA affects over 600M people worldwide and is anticipated to afflict 25% of US adults by 2030. Unfortunately, there is no cure for OA and patients are left with painkillers and corticosteroids to bring about temporary, symptomatic relief. There is an enormous need for a treatment that actually addresses the root cause of osteoarthritis, undoing the cartilage damage caused by the disease, instead of merely masking the symptoms.
Osteoarthritis is a degenerative joint disease defined by the breakdown of the protective cartilage tissue that provides support within articular joints. This breakdown is caused by a cascade of molecular mechanisms that result in the hyper-activity of a class of enzymes called “proteases.” These proteases act like molecular “Pacmen,” chewing up the cartilage tissue, rendering the joint brittle, inflamed, immobile, and painful. OA can affect any joint, from the knees, ankles, toes, shoulders, elbows, wrists, fingers, and hips, to the vertebrae within the spine.
Our new drug, “CYT-108,” has been proven to protect cartilage against damage and restore joint health in preclinical studies. Now, we are ready to begin our first-in-human Phase 1 clinical trial for CYT-108 as a treatment for osteoarthritis. Once approved by the FDA, CYT-108 will be the first and only OA treatment that targets the root molecular cause of the disease instead of just treating the symptoms.
Osteoarthritis is caused by hyperactive proteases, a class of catabolic enzymes that chew away at the cartilage matrix. A successful treatment must address these root molecular forces to reverse the cartilage damage caused by the disease
The Autologous Protease Inhibitor Concentrate (APIC) therapy
Cytonics’ FDA-approved APIC therapy leverages the cartilage-protecting properties of a naturally occurring blood protein, called alpha-2-macroglobulin (A2M), by purifying the A2M from a patient’s own blood and injecting it into their arthritic joints. The clinical and commercial success of this first-generation therapy is a testament to A2M’s ability to treat osteoarthritis. CYT-108 is a variant of this naturally occurring A2M protein that has been genetically modified to increase its potency and cartilage-restoring abilities.
The logic is simple: We already know that A2M works as a treatment for OA… and now we have developed a superior, patented version. Essentially, we have “improved on Nature’s design.”
Why make a new OA treatment when we already have one? Simple. While our APIC therapy has treated over 8,000 patients to date, it’s costly and involves drawing and processing patients’ blood.
Cytonics has proven that CYT-108 is significantly more potent than the natural A2M protein in preclinical experiments and has demonstrated that CYT-108 is safe to administer and prevents damage to cartilage (and other joint tissues) associated with osteoarthritis.
Cytonics is preparing for a first-in-human Phase 1 clinical trial anticipated to start in early Q1 2023. The company is currently conducting their final preclinical study to submit to the FDA in an Investigational New Drug (IND) application in Q3 2021.
Preliminary preclinical data demonstrates CYT-108’s efficacy in preserving the cartilage and surrounding tissues (e.g., synovial membrane) in a large animal model of post-traumatic osteoarthritis. Regular treatments of CYT-108 (or placebo saline solution) were injected into the damaged joints along a 12-week treatment window. Pieces of the cartilage and surrounding tissues were examined to measure the cartilage-protective effects of CYT-108 and its ability to encourage joint remodeling/healing. In summary, the administration of CYT-108 into the joint restored the damage caused by osteoarthritis to the cartilage and synovial membranes by ~60%. Read more here.
Since our last raise (2021), we have accomplished all of our milestones in pursuit of advancing CYT-108 into FDA human clinical trials. These accomplishments include manufacturing GMP-grade CYT-108 protein for our final preclinical study (“IND-enabling toxicology study”) and an imminent Phase 1 clinical trial (planned for Q1 2023). Now, we are calling on investors to help fund our first-in-human Phase 1 clinical trial and advance CYT-108 one step closer to FDA approval.
Once approved by the FDA, CYT-108 will be the first and only OA therapy on the market that targets the root molecular cause of the disease. CYT-108 will not only alleviate the joint pain and inflammation associated with osteoarthritis, but it will reverse the cartilage damage and progression of OA, providing patients with a long-term and effective therapy solution.
Invest in our next growth phase as we prepare for Phase 1 human clinical trials.
In addition to the FDA-approved APIC therapy and novel CYT-108 biopharmaceutical under development, we also have an OA biomarker test in the market and are pursuing FDA approval for a modified APIC device called the “APIC Mini” (a more cost-effective solution for smaller joints).
We have completed preclinical studies for our genetically modified A2M variant, “CYT-108,” and are ready for our first-in-human Phase 1 clinical trial. Our Contract Manufacturing Organization, Goodwin Biotechnology, has purified our GMP-grade CYT-108 for human clinical studies.
Our Autologous Protease Inhibitor Concentrate (APIC) therapy works by concentrating the naturally occurring, therapeutic A2M protein found in the bloodstream and delivering this purified A2M into arthritic joints. APIC is FDA approved and has been used to treat over 8,000 patients to date. We have licensed the manufacturing and distribution rights to 3rd parties in the human and veterinary markets. It is being used to treat race horses with outstanding success!
We have developed a smaller, less expensive APIC system dubbed “APIC Mini” to provide physicians with a solution for treating small joints (such as fingers) that do not require as much volume. The APIC Mini also has the potential for veterinary applications.
Cytonics is disrupting the field of regenerative medicine with their innovative biologic therapies for osteoarthritis. Returning Reg A+ investors that make another investment will receive perks equivalent to one tier above their investment amount. Learn more about the investor perks below.
Invest in our next growth phase as we prepare for Phase 1 human clinical trials.
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