Coronado Biosciences is developing a helminthic therapy treatment for Inflammatory Bowel Diseases such as Crohn’s Disease & Ulcerative Colitis that may open the therapy up to mainstream medicine.

Helminthic therapy is the treatment of autoimmune diseases or disorders via parasitic organisms, usually worms of some sort. Why helminthic therapy works rests on the hygiene hypothesis, which suggests that modern hygiene habits at an early age may be reducing the ability for our immune system to develop initially & later regulate itself. The idea is that without early exposure to certain pathogens, the immune system becomes reliant on allergic and/or inflammatory responses to common pathogens or irritants.

There is also the theory that parasitic organisms have evolved with the human immune system. Over time both have tried to outwit the other, with the immune system ramping up it’s attacks & parasites ramping up their ability to calm the immune system down so it doesn’t attack them. Those who have a ramped up immune system, but no parasitic infection that it can attack, may find the immune system turning on itself. Maybe we should call this “raging immune system disorder” as the immune system is just looking for a fight, but it can only hurt itself. Introduction of a parasite, such as whipworm or hookworms may be the key to calming the immune system down.

Helminthic therapy has only recently started getting more attention in places like North America & the UK. There is the “ick” factor involved with infecting oneself & most doctors are unaware or unwilling to try such a treatment. This has led people like Jasper Lawrence to go it alone. Jasper went so far as to infect himself to relieve severe allergies & created a side business selling hookworms under his company Autoimmune Therapies. Unfortunately Jasper’s operation was shutdown in the USA by the FDA. Since Jasper didn’t have the money to go through the FDA regulatory process he moved out of the USA. You can still get hookworms from him, but you must arrange travel outside the USA to retrieve them & it’s obviously not cheap.

This is where Coronado Biociences is stepping in with their CDNO-201 therapy treatment. Luckily they do have money, having secured $25.8 million in funding recently & they are going through official FDA channels. CDNO-201 is an orally administered treatment that relies on a whipworm species known as Trichuris suis, which is normally found in pigs. Since they do not normally hang out in humans the human immune system will eventually kill them off after a few weeks. While they’re not native to humans they still have the same benefit in that they will be trying to calm the immune system & also giving it something to attack besides the body. Trichuris suis reproduction process requires any eggs produced to sit in soil for a few days before they are activated & can infect a new host. This makes it extremely unlikely that anyone within the same household would become infected from the person receiving treatment.

Since the body will naturally get rid of the whipworms after a few weeks, it makes it easy to stop treatment with out the need for antibiotics. Although this may also lead to needing multiple treatments each year, which may mean more cost for those who would need constant long-term helminthic therapy. Treatment plans for some may be devised where they only receive treatment when experiencing a flare-up of their symptoms.

In a small pilot study, each of 7 IBD patients (4 patients with CD, 3 patients with UC) improved clinically, with of 6 of 7 (86%) patients achieving remission according to the IBD Quality of Life Index (IBDQ) (Summers 2003). A subsequent open-label trial demonstrated clinical response and remission rates of 79.3% and 72.4%, respectively, in 29 CD patients after treatment with 2500 live TSO three weeks for 24 weeks (Summers 2005a)

Coronado Biosciences will be holding company funded Phase II trials in early 2012.