Jenken’s lead compound: JKB-122 is an off-patent drug that has newly discovered anti-fibrotic, immuno-modulating
and anti-inflammatory properties that normalize abnormal liver function and prevent inflammation-associated liver
damage in animals. Between the two repurposed compounds to be advanced first by Jenken, JKB-122 is the lead compound
because it has already been positioned to enter a Phase II clinical trial soon after funding is available. The Company’s
IND submission for a Phase II clinical trial for JKB-122 was approved by the FDA by letter dated December 6, 2006. Jenken
has filed broad U.S. and foreign patent applications for new uses in organ damage. Based on a March 2007 USPTO Office
Action approving key utility claims for “organ damage,” the Company expects to receive a Notice of Allowance in Q4 2007.
At the conclusion of the Phase II trial for JKB-122, we will aggressively explore other proprietary drug delivery or dosage
forms that would optimize its therapeutic effectiveness as well as provide additional patent protection.
The endpoint for the Phase II trial is to restore liver function in Hepatitis C patients who do not respond to current interferon
(anti-viral) therapies. Proof of concept will be demonstrated by restoring elevated liver enzyme (ALT) levels to normal ranges. The
endpoint for the Phase III trial is to improve liver damage through biopsies.
The hepatitis drug market is $2.7B (2004) with forecasted annual growth of 12%. Current therapies for Hepatitis C are inadequate.
More than forty percent (40%) of Hepatitis C patients are non-responsive or cannot tolerate the side effects of current interferon
treatments and face liver failure and death due to inflammation-associated liver disease. It is this patient population that we will target first.
Risk reduction business model: Finding new therapeutic uses for off-patent drugs that are already marketed or approved
for other indications, dramatically reduces the overall development risk, cost, and time-to-market, as the safety profile of the repurposed
drug is already well established. Further, Jenken’s proprietary technology for cytokine modulation, a specific therapy for chronic inflammation,
differs from most, if not all of the anti-inflammatory drugs available today. It offers the potential to fulfill the unmet medical need of
restoring normal liver, kidney and lung function, regardless of the cause of the damage or disease.
Pipeline Development: While inflammation associated liver damage in Hepatitis C non-responders has been selected as the
first indication for JKB-122 (second year U.S. sales estimated at $100M+), large opportunities remain for other instances of liver disease
such as non-alcoholic and alcoholic fatty liver diseases, as well as other organ dysfunction, including inflammation associated renal, and
lung diseases, organ cancer, and neurodegenerative diseases. Conservatively, these diseases have a worldwide market potential in the $10B+ range.
Jenken is developing additional compounds with structures related to JKB-122 (e.g., JKB-121, a repurposed compound, JKB-119, an NCE compound),
and flavonoids. These second-generation compounds also appear to exhibit novel immuno-modulating and anti-inflammatory profiles, including
anti-fibrotic activity and liver protection in a NASH animal model. All three compounds are covered by the above-referenced patents pending
with broad claims for organ damage. Some of the flavonoids exhibited good anti-TNF-a activity in cell assay.