In an exclusive interview with Thomas Warner from Proactive, Matthew Davis, the chief medical officer and chief operating officer of Tiziana Life Sciences Ltd (NASDAQ:TLSA), discussed the company's latest six-month PET scan data for treating non-active secondary progressive multiple sclerosis (MS).
The data show improvements in five out of six patients, supporting the drug's hypothesis published in the Proceedings of the National Academy of Science.
Davis highlights the business significance of these findings, especially in the U.S., where no FDA-approved treatment exists for this specific MS type, affecting approximately 200,000 patients.
Thomas Warner: So perhaps you can get us up to speed with this morning's announcement about your six-month PET scan results, please.
Matthew Davis: Certainly. This is a momentous occasion for us. When we last discussed our PET scans, we were looking at three-month data. At that point, we had seen improvement in five out of six of our patients who have non-active secondary progressive multiple sclerosis.
Now, we're announcing that we have six months of data, and the results are consistent. Five out of six of our patients show improvements in their PET scans. This is incredibly exciting for us because it validates the hypothesis of the drug, which has been published in the Proceedings of the National Academy of Science.
The drug works by stabilising microglia, the brain's innate immunity, and putting it back into a calmer state. The PET scans are a way to measure this, and it's very gratifying to actually see these results. We're looking forward to hopefully seeing the same type of results in our clinical work.
TW: That sounds very promising. Could you elaborate on the science behind these results? How does the drug work at a molecular level?
MD: Absolutely. The drug works by targeting microglia, which are a type of cell in the brain and spinal cord that function as the first and main form of active immune defence in the central nervous system. When these cells are in a hyperactive state, they can contribute to the progression of multiple sclerosis.
Our drug aims to stabilise these cells, bringing them back to a calmer, homeostatic state. This is crucial for managing neuroinflammation, which is a key factor in multiple sclerosis and other neurodegenerative diseases.
TW: What is the business significance of these results?
MD: The business implications are substantial. In the United States, there's no approved treatment for this specific type of MS, which is non-active secondary progressive. So, roughly 200,000 patients have this disease, and currently, there is no FDA-approved treatment. This is a significant unmet medical need.
Our results are taking us to the next step, and we'll be starting our phase 2a programme very shortly. The primary endpoint for this next phase will be PET change, which is prognostic of a successful phase 2a programme.
TW: Could you tell us more about the phase 2a programme? What are the key milestones you're looking at?
MD: The phase 2a programme is designed to further validate the efficacy of our drug. We'll be focusing on PET change as a primary endpoint, which means we'll be closely monitoring the PET scans of our patients to evaluate the drug's effectiveness. The key milestones include patient recruitment, interim analysis, and of course, the final results. We're also looking to collaborate with other research institutions and possibly expand the trial to include more diverse patient populations.
TW: You've been in Milan this week talking about Multiple Sclerosis. How was that?
MD: It was an incredible experience. I had the opportunity to deliver a keynote speech at ECTRIMS, where microglial activation was a central topic in the plenary session. It's very gratifying to see that the scientific community is recognising the importance of targeting neuroinflammation in the treatment of not just multiple sclerosis, but also other neurodegenerative diseases like Alzheimer's.
TW: What are the next steps for Tiziana Life Sciences in terms of research and development?
MD: Our immediate next step is to initiate the phase 2a programme. We're also exploring partnerships and collaborations to accelerate our research. In the long term, we're looking at expanding our portfolio to include treatments for other neurodegenerative diseases, leveraging the insights we've gained from our work on multiple sclerosis.