FibroBiologics is a clinical-stage company developing fibroblast-based therapies to treat chronic diseases. DocWire News sat down with Hamid Khoja, PhD, the company’s Chief Scientific Officer, about fibroblasts and their potential in treating chronic diseases.
DocWire News: What are fibroblasts and how are they different from stem cells? Why are fibroblasts not as well-known as stem cells if they can both regenerate tissue?
Dr. Hamid Khoja: Fibroblasts are actually one of the most universally abundant cells in the human body, typically in all mammalians. They’re responsible for making the connective tissue in our systems and our organs, et cetera, and then maintaining the connective tissue. They’re also a major component of wound healing. When you cut yourself, fibroblasts are the cells that are involved in every aspect of the wound healing process.
They can also differentiate into multiple cells, like stem cells. They can differentiate into adipocytes, chondrocytes, making cartilage. They can make adipocytes, fat tissue, hepatocytes, so they can differentiate into multiple tissue types. They also have a very strong immune modulation capability. Now a lot of these aspects are shared with stem cells, true. The reason why stem cells are well known, is because of the patents and the Noble Prize that was won by introducing stem cells, et cetera. That’s what there is a surge of interest. There has been a surge of interest in the last two decades for developing stem cell based therapies, et cetera, that are slowly progressing. They haven’t reached that.
But fibroblasts, they basically have the same capability, a lot of the same capabilities of stem cells, but they’re significantly more abundant and easier to source than stem cells. Just to give you an idea for every single stem cell that’s in the human body, there exists about 10 to 12,000 fibroblasts. So in terms of being able to source it, in terms of being able to culture and manufacture stem cell based therapies, it’s significantly more expensive than using fibroblasts.
What are FibroBiologics developing fibroblast therapies for? What other indications can fibroblasts be used to treat?
Yeah. Our aim is to use fibroblasts to treat quite a few number of chronic diseases. For example, multiple sclerosis, which is an autoimmune disorder. Our animal model studies as well as our clinical trials show that it’s safe, but we do see efficacy in animal models. We do see a significant improvement in some of the disabilities that are caused by multiple sclerosis. We also are looking at generative disc disease, one of the most chronic diseases in the United States, if not the world.
We’re also looking at wound healing to be able to heal wounds faster, specifically in diabetic ulcers and pressure caused ulcers otherwise known as bed sores, but also looking at wounds that are very difficult to heal, whether it’s by age or by the severity, et cetera. We’re looking at that as well. We’re also looking at using fibroblasts to reverse thymus involution, which occurs by age. So by being able to reverse the thymic involution, we should be able to reduce the risk of cancer in some of the autoimmune disorders that are noted as you age.
What happens in Multiple Sclerosis? How will fibroblasts treat the condition of Multiple Sclerosis?
Yeah. I mean, multiple sclerosis is a T cell mediated autoimmune disorder in which the myelin sheath that insulates the neural bodies are attacked and destroyed. So the condition exists in several stages and basically what we’re doing is using fibroblasts to modulate the immune system to reduce the inflammation, thereby allowing the recruitment of stem cells to rebuild the oligodendrocytes and rebuild the myelin sheath around the nervous system. Our animal models system are in vivo. Studies have been very promising in that it shows a higher expression of myelin, which means that the myelin sheath is rebuilding. We see a higher expression of some of the proteins that are known, that are described as markers of oligodendrocytes increasing. So that means we’re seeing an improvement in the repair of the damaged tissue. But also we’re noticing on our clinical trial, we did a phase zero one clinical trial. We showed that it’s very safe and we did see some improvement and some efficacy, which were secondary endpoints in the patients that were enrolled in the trial. So we’re very excited to do a larger clinical trial and see the complete impact of the efficacy of fibroblasts for multiple sclerosis.
What is Disc Degenerating Disease (DDD)? How far along is your company’s program in DDD?
Degenerative disc disease, as I mentioned, it’s one of the most predominant chronic diseases in the United States. Billions of dollars are spent every year in trying to treat.And all the treatments are basically analgesic. There are at least 13 to 15,000 surgeries done in terms of fusion, et cetera, replacing some of these discs. They tend to be very expensive running anywhere between 60 to $150,000 in treatment. So what we’re trying to do is to… And what we’ve done, we’ve shown in animal models, but also in our clinical trial that we can reduce the inflammation significantly by introducing fibroblasts directly into the vertebral disc regions that are damaged, reduce the inflammation. We also have indications from the animal model studies that we can rebuild some of the discite. We did recently complete a phase one two clinical trial and looked with the primary outcome being safety, but also looking at pain reduction and opiate use in the patients that were enrolled and we’ve seen a very good result so far.
Well, we’re still analyzing the data completely, but so far, the data looks promising in that we should be able to see a reduction in pain and opiate use. Hopefully we could see some changes in the discite, but that data is being analyzed. We should have done out in a few months, once I’ve done a complete analysis of the data.
When ready, would a fibroblast treatment be a one-shot administration, or would multi-doses be needed?
Well, the clinical trials that we’ve done, as I said is primary safety. They were one shot, but I think for our next clinical trial for MS we will definitely be looking at not only multiple doses, but different dosage concentrations to see the efficacy in a long term study.
I think if you look at all the other treatments that are currently available for MS and even other diseases it’s multiple, but for small molecules or even antibody based treatments they tend to be multiple dosage that are repeated at certain intervals. We expect a similar impact or a similar case for fibroblast based therapy that in order to see good efficacious results and continuing efficaciousness results, most likely multiple dosage at certain intervals will be required.
Can you tell us a little bit more about what else is upcoming in the pipeline?
Well, as I mentioned, two of the products in the pipeline currently are MS, multiple sclerosis. We intend on filing an IMD by the end of the year for a phase one two clinical trial. Degenerative disc disease, once we analyze the data, we can see what the next step is. We’re also starting some animal trials on wound healing as well. So we hope to see some more results and file an IMD for that, hopefully by the end of the year. Yeah, I think in terms of fibroblast therapy, it’s not very well known and it’s a new field. Stem cells have certainly been the focus, but I think we are seeing more and more publications coming out and utilizing fibroblasts for a variety of clinical applications. As a company that has over 300 patents on the use of fibroblasts in a clinical setting, I think we’re very well staged on being successful. So we’re hoping to be the primary fibroblast based therapy company in the future.