|Q&A with Coronado Biosciences CEO Harlan Weisman, M.D.|
|By Staff and Wire Reports|
|Tuesday, 23 July 2013 01:27|
Q: What is TSO and how do you think it will work to combat autoimmune diseases?
CEO Harlan Weisman: Rates of autoimmune diseases are relatively high across the developed world. According to a concept called the “hygiene hypothesis,” which many more people are now familiar with, there’s a direct link between the rise in autoimmune disease incidence rates and modern Western society. Some researchers think it’s possible that improved hygiene—by ridding our bodies of parasitic worms and beneficial bacteria—have paved the way for higher autoimmune disease rates.
Researchers have suggested reintroducing microbes into our bodies to help treat some of the patients with autoimmune diseases. Reintroducing microbes increases the diversity of the micro flora. People without autoimmune disease and also people who are normal weight (in contrast to obese) have a more diverse microbiome than those with disease.
One promising approach is our treatment involving Trichuris suis ova (TSO)—pig whipworm eggs. Studies have shown that once TSO has been swallowed by a patient, the eggs take up residence in the gut and regulate the immune system in a way that can reduce a range of symptoms. This natural approach was chosen because Trichuris suis ova are pig whipworm, and not human whipworm; therefore, the ova cannot grow into worms and colonize in a human. In fact, if treatment is stopped, within two weeks the worms are no longer present in the body.
There are many autoimmune and immune-mediated diseases—including Crohn’s disease, ulcerative colitis, multiple sclerosis, type-1 diabetes, autism and psoriasis—whose symptoms researchers think could be addressed using TSO.
Q: What effects does TSO appear to have on the body?
CEO Harlan Weisman: The worms appear to produce three major effects on the immune system: they seem to trigger changes that activate and increase the number of regulatory T cells which dampen immune responses and curb autoimmunity; they seem to act on other cells to prevent the “switching on” of dangerous effector T cells, which customarily results in inflammation and disease; and they seem to alter the makeup of intestinal flora—they foster the growth of gut microorganisms customarily considered “probiotic,” which assist in maintaining intestinal health.
Overall, in our Phase I study in Crohn’s disease, TSO was found to be safe and well tolerated across all three dose levels tested. There were only two adverse events (metallic taste and sour taste) that were considered to be related to TSO as assessed by the study investigators, one that was reported in the 7500 ova dose group and the other in a patient receiving placebo, respectively. All other reported events were assessed as unrelated to the study drug and were self-limiting.
Q: Several months ago Coronado brought you aboard as its new CEO. What strengths do you bring to the company?
CEO Harlan Weisman: I have served on Coronado’s board since August 2012. Previously I worked at Johnson & Johnson, where I held various leadership positions. Before that, I was head of R&D at Centocor, the developer of Remicade. I have now turned my attention to oversee Coronado’s TSO development efforts and steer the company toward success, and I am extremely enthusiastic about our chances for success.
I am not alone among new recruits. We have recently been joined by Thomas F. Schaible, Ph.D. as Project Leader, Inflammatory Bowel Disease, who will lead our R&D efforts in advancing TSO in this indication. We also have appointed George Avgerinos, Ph.D. as Senior Vice President, Biologics Operations, who will lead our global manufacturing and supply chain efforts. Our team is much stronger as a result of these additions.
Q: What is the status of the TRUST-1 study?
CEO Harlan Weisman: Coronado Biosciences announced on July 1st that it completed enrollment of a Phase 2 study of TSO in Crohn’s disease. The trial, known as TRUST-I, has enrolled 250 patients, both males and females between the ages of 18 to 65, with moderately to severely active Crohn’s. As there has been a lot of patient interest in this trial, we were quite pleased to see that the final number of patients surpassed the target enrollment of 220 patients to accommodate individuals in the screening process when the trial's enrollment goal was achieved. Patients enrolled into the study are receiving either 7500 TSO or placebo once every two weeks, for 12 weeks. Researchers are measuring the response rate according to the Crohn’s Disease Activity Index (CDAI). We expect to release results in the fourth quarter of 2013. Additional study details can be found at www.clinicaltrials.gov.
Q: What reaction are your efforts receiving from the medical community as a whole?
CEO Harlan Weisman: The interest from the medical community to study TSO in a number of autoimmune diseases has been really impressive. We have received and continue to receive requests and proposals for clinical trials from leading clinicians and researchers around the world. We take these requests very seriously and review each of them in detail. In many cases, the requests come with funding already identified from leading research organizations, significantly extending the number of new indications we can explore.
Q: What are some of the other TSO studies that have started since we last spoke?
CEO Harlan Weisman: As I mentioned, we’ve been really encouraged about the amount of interest TSO continues to receive from the medical community. We currently have four investigator-sponsored trials in ulcerative colitis, autism, psoriasis and multiple sclerosis, which are all underway with world-renowned physicians. We potentially will have data in autism and psoriasis around the end of this year. We are also planning additional investigator-sponsored studies in Type-1 diabetes, autism, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis, which is being funded with grant money from the National Institutes of Health.
Q: If trials go as planned, where do you think TSO could fit among TNF-alpha inhibitors?
CEO Harlan Weisman: TNF-alpha inhibitors have significantly advanced the treatment of autoimmune diseases. However, there is still a critical need for additional treatments that will provide high continuous effectiveness, improved safety, and a more convenient method of dosing to ensure that people take the drug and are satisfied with the treatment. We believe that the use of TSO may offer a promising option to the current array of available TNF-alpha inhibitors for the millions of Americans who have these conditions.