It is indeed the Year of the Worm. Last year,
about Coronado Biosciences (
) and "The Hygiene Hypothesis," a theory that explains why exposure
to parasites and worms can be mutually beneficial for the survival
of not only the worms, but also their human hosts.
Coronado Biosciences exists for one main reason: autoimmune
conditions. The charts and diagrams posted in this article can be
found on the company's website. Over the last several decades, as
industrialized countries developed and improved their fight against
"the bugs" with better antibiotics, anti-viral, and anti-worm
medications, we claimed victory against bacteria, viruses, and
parasites that have existed mutually not only in our environment
but within our own body for thousands of years.
To our surprise, what we have also noticed is that while the
battle is being won against the bugs, the incidence of autoimmune
conditions has increased over time.
There are over 100 immune-mediated diseases; the ones that have
emerged in the headlines cause high morbidity, mortality, and
healthcare costs to our society. These include type 1 diabetes;
multiple sclerosis; inflammatory bowel disease, including Crohn's
disease and ulcerative colitis; and rheumatoid and psoriatic
arthritis. Even the growing incidence of autism has been attributed
to a possible immune-mediated disorder.
Autoimmune conditions are chronic. We have no "cure." The
healthcare costs of treating these conditions are astoundingly
Abbott Lab's (
) Humira, Johnson and Johnson's (
) Remicade, Teva's (
) Copaxone, Elan's (
) Tysabri, Biogen's (BIIB) Avonex, Pfizer's (PFE) Rebif, Novartis'
(NVS) Gilenya, all represent billions of dollars of injectable
treatment for autoimmune conditions.
Take, for example, the costs of treatment for just three
conditions that require "injectable" medications (often lifelong)
for maintenance treatment. We are looking at the treatment costs of
only the U.S. and Japan as well as the prevalence of disease:
With these three autoimmune conditions alone, over $10 billion
dollars are spent in the Annual Market Sales of medication
treatments. This cost curve will only rise over time as the
incidences of these autoimmune disorders increase over time, not
only here in the U.S., but in developing countries around the
Notice the Distribution of Autoimmune Disorders around the world
(see below); areas that have a high prevalence of autoimmune
disorders have a low parasite/helminths infestations incidence.
This is a very simple correlation: areas that have more worms
equal less autoimmune conditions. Areas that have less worms equal
more autoimmune conditions. Basically if you grew up in a "third
world" country, your chances for worm infestation are high and your
likelihood of developing an autoimmune condition is low.
Why do we see this correlation? The Hygiene Hypothesis explains
that over the centuries, there has been a symbiotic, mutually
beneficial relationship between humans and the "parasites" that
live within us. In order for the parasite to survive inside its
host, it "modulates" our immune system in a way that allows the
host to live longer (and indirectly the parasites live longer).
This "immune modulation" allows our immune system to not only avoid
attacking the parasite, but prevents it from attacking our own
bodies as well (autoimmune disease).
So what is Coronado Biosciences doing to address worms and
autoimmune conditions? Well, Coronado has Pig Whipworm Eggs
(Trichuris Suis Ova: TSO).
Four efficacy clinical trials have already been completed with
positive results: TSO treatment in Crohn's disease, ulcerative
colitis, multiple sclerosis, and even treatment of acute myeloid
Here's a brief synopsis of these completed studies:
Multiple Sclerosis Study:
Five patients with MS brain MRI documented a mean of 6.6 MS
brain lesions at baseline. Treatment with oral TSO was administered
over three months. Follow up MRI after treatment shows the number
of brain lesions decreased to 2.0. Two months after TSO
discontinuation, the mean number of lesions rose back up to 5.8. No
adverse reaction to TSO was noted.
Crohn's disease study:
Twenty-nine patients with active Crohn's disease were treated
with TSO orally every three weeks for 24 weeks. At 12 weeks and 24
weeks data was collected indicating that 79.3% of patients
experiencing a positive response and 72.4% achieved remission.
There were no severe side effects of TSO reported.
Ulcerative Colitis Study:
Fifty-four patients with active Ulcerative Colitis participated
in a randomized, double-blind, placebo controlled study (some
patients received placebo while others received TSO). Duration of
study was 24 weeks long. The graph below shows the difference in
positive response between TSO group and placebo group. The worm
group had a more than doubled percentage improvement over the
The fourth study involves treatment of AML (Leukemia) with a
second product with positive results as well. I am going to skip
discussion of this study to focus on autoimmune disorders.
So what's been going on with Coronado Bioscience since my last
Here are some milestone highlights:
Company receives Notice of Allowance for First US patent
Company receives Orphan Drug Designation from FDA for CNDO-109
for treatment of AML.
Company added to Russell 3000 Index.
Company announces initiation of Phase 2 study for treatment of
Company announces initiation of Phase 2 study for treatment of
Company granted First US patent covering CNDO -109.
Company announces study for treatment of Autism.
Company initiates Phase 1 and Phase 2 trials of CNDO-109
treatment of Leukemia.
Company acquires TSO manufacturing rights from Ovamed. This will
enable production of Phase 3 supplies of TSO and establish control
over TSO manufacturing.
Company appoints Harlan Weisman, M.D., as its new Chairman and
CEO. Dr. Weisman has substantial expertise in launching novel
biologics. Here is some information that was copied and pasted from
the company's press release:
Company announces initiation of study evaluating TSO in
So why is 2013 the Year of the Worm?
Three Issued US Patents with Five Additional Patents
Manufacturing Rights in Place for Phase 3 Studies
A Pipeline Full of Worms
Two Major Crohn's Disease Studies Results in 2013 Involving
Approximately 500 Patients
On December 20, 2012 Wedbush Securities
on CNDO with an outperform rating and a $13 price target.
On January 3, 2013 CNDO is the top pick for 2013 by John
McCamant of the
Technology Stock Letter
with an 18-month target of $20 per share.
On January 22, 2013 Roth Capital named Coronado Biosciences a
Top 2013 Biotech Pick
with a one year price target of $24.
On March 1, 2013 Piper Jaffray Initiated CNDO with an Overweight
with Price Target $17.
If the upcoming TRUST studies verify successful treatment of
Crohn's Disease with their worms, our treatment paradigm for
various autoimmune conditions may shift: shifting away from the
multi billion dollars market of immune suppressing injectable
medications and toward a symbiotic relationship that has lasted for
centuries between human and worms.
I am long [[CNDO]]. I wrote this article myself, and it expresses
my own opinions. I am not receiving compensation for it. I have no
business relationship with any company whose stock is mentioned in
Apple: Is It Finally Time To Buy?