In this interview, we spoke with Joey Bose, President & CEO of Cytonics, diving into the intricacies of their groundbreaking CYT-108 clinical trial. This trial marks a significant stride in osteoarthritis therapy, potentially revolutionizing how we understand and treat this debilitating condition. Joey Bose offered insightful perspectives on the development, challenges, and future aspirations of CYT-108, shedding light on what could be a landmark advancement in medical science.
Moe Alsumidaie: Could you elaborate on the current phase and progress of the CYT-108 clinical trial in osteoarthritis treatment?
Joey Bose: Cytonics has recombinantly engineered a variant of the Alpha-2-Macroglobulin (A2M) blood protein. In its natural role, A2M is an anticoagulant via protease inhibition. We have tuned this anti-protease activity to target the three major classes of proteases responsible for cartilage damage in arthritic joints. The genius is that it is both broad-spectrum and highly specific… We’ve successfully completed preclinical studies and animal model trials, showing promising results. We’re at a crucial juncture, preparing to embark on our Phase 1 clinical trial in Q1 2024, primarily focusing on safety and gathering early efficacy data.
Moe Alsumidaie: Fascinating. How does CYT-108 stand out in its approach to treating osteoarthritis?
Joey Bose: The design of the CYT-108 trial underscores our commitment to innovation in osteoarthritis treatment. This isn’t just another palliative measure; it’s a substantial leap toward altering the disease’s trajectory. CYT-108 is not a superficial fix—it’s a robust molecule that specifically targets the joints, staying where needed without dissipating into the body indiscriminately. This is The Holy Grail of regenerative medicine that has eluded Big Pharma for decades. In our Phase 1 trial, we’re prioritizing safety and integrating an efficacy study, albeit on a smaller scale. This will involve monitoring the levels of cartilage degradation products in our participants’ bloodstreams. It’s a strategic move that allows us to gather valuable early data on the therapeutic efficacy of CYT-108, setting the stage for future trial phases.
Moe Alsumidaie: Regarding regulatory pathways, how are you navigating this with CYT-108?
Joey Bose: We are pursuing the biologics license application route with the FDA, given that CYT-108 is a recombinant protein. Our strategy includes starting the first human study in Australia, due to more streamlined regulatory processes and significant R&D tax incentives, and a parallel IND filing with the FDA for U.S. trials. This approach helps us mitigate regulatory challenges and expedite the trial process.
Moe Alsumidaie: Can you discuss the unique challenges in conducting osteoarthritis clinical trials, particularly with a treatment like CYT-108?
Joey Bose: The major hurdle in osteoarthritis trials, including ours, is the high placebo effect, which can be upwards of 40%. This makes demonstrating statistically significant, clinically meaningful efficacy challenging. Our Phase 1 trial will include surrogate efficacy endpoints to address this, providing early, encouraging biomarker data. We’re also considering extending the trial duration, if needed, to capture more substantial changes in patient outcomes.
Moe Alsumidaie: How are you addressing patient variability in your clinical trial design for CYT-108?
Joey Bose: Osteoarthritis affects patients differently, so we’re implementing strict inclusion and exclusion criteria in our trial design. We’re focusing on patients with a specific severity of knee osteoarthritis, avoiding extremes where the joint is too healthy or damaged. Factors like age, comorbidities, and previous treatments are carefully considered to reduce variability and improve the reliability of our results.
Moe Alsumidaie: Finally, what are the future steps and aspirations for Cytonics with CYT-108?
Joey Bose: Post-Phase 1, we aim to partner with a mid-sized pharmaceutical company for Phase 2 development, leveraging their expertise and resources. We aim for a strategic partnership to co-develop CYT-108 and eventually seek avenues like IPOs or private acquisitions for wider reach and impact. Our immediate focus is successfully navigating the Phase 1 trial and setting a strong foundation for future development.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
