Products
home » products » anti-inflammatory drugs

Inovio Product Pipeline: VGX™-1027: Anti-Inflammatory Compound

Product & Indication
VGX™-1027 is an orally bioavailable drug for the treatment of inflammatory diseases including rheumatoid arthritis (RA), Type 1 diabetes (T1D), uveitis, and colitis. It is a novel inhibitor of pro-inflammatory responses including TNF-alpha.

Market Potential
In the U.S. alone, 1.3 million people suffer from rheumatoid arthritis (RA) according to the National Institute of Arthritis and Musculoskeletal Skin Diseases (NIAMS).i Overall, the prevalence in North America and the European Union is expected to increase until at least 2010, due to the aging population. With significant unmet clinical need and the progressive introduction of higher value and more effective biopharmaceuticals, the rheumatoid arthritis market is expected to more than double in value to $27 billion by 2015.ii

As of 2007, 23.6 million Americans-7.8 percent of the population-have diabetes, of which an estimated 5.7 million people are undiagnosed. Type 1 Diabetes (T1D), which can be fatal if untreated, usually strikes children and young adults, although it can strike at any age. In adults, T1D accounts for 5 to 10 percent (0.9 million -1.8 million people) of all diagnosed cases of diabetes in the U.S. alone. Risk factors for T1D may be autoimmune, genetic, or environmental. No known way to prevent type 1 diabetes exists.iii

There are over 1 million ulcerative colitis patients in the world, with seven major markets in the U.S. Japan, France, Germany, Italy, Spain and the UK.iv Colitis, a chronic digestive disease characterized by inflammation of the colon, is an inflammatory and auto-immune condition affecting the tissue lining both the large and small intestines. Colitis is an inflammatory bowel disease (IBD), as opposed to an irritable bowel syndrome (IBS).

Stage of Development
Phase: I, single ascending dose (SAD) and multiple ascending dose (MAD) studies in healthy volunteers complete. Conducted by SNBL Clinical Pharmacology Center, Inc.

Purpose: To evaluate the safety profile, tolerability and pharmacokinetics in healthy subjects following SAD up to 800 mg and MAD of up to 200 mg twice-a-day

Study Type: Safety and pharmacokinetics

Study Design: Randomized, double-blind (Subject, Investigator), placebo controlled

Study Start Date: September 2008

Status: Study completed

For more information: www.clinicaltrials.gov Identifier: NCT00760396

Commercialization
Drug: Licensed from Ganial Immunotherapeutics, Inc.

Out-license agreement: TBD.

Technical

Rheumatoid Arthritis (RA)

  • Autoimmune disorder: inflammatory disease leading to irreversible joint damage, deformity and disability
  • Affects 2.5 million Americans
  • 50,000 people develop RA each year; more common in females
  • Increased mortality compared to the general population
  • Cause of RA is unknown

Ref. www.niams.nih.gov

VGX™-1027
  • Small Molecule drug candidate for the treatment of RA
  • Orally bioavailable
    Novel mechanism of action
  • Preclinical efficacy against various inflammatory diseases: RA, TID, and colitis

Type 1 Diabetes

  • Autoimmune disease that results in the permanent destruction of insulin producing beta cells in the pancreas.
  • TID is usually diagnosed in children and young adults, and was previously known as juvenile diabetes.
  • TID is treated with insulin replacement therapy- usually by injection or insulin pump- diet modification, exercise, and careful monitoring of blood glucose levels using Glucose meters.
  • Untreated diabetes can lead to one form of diabetic coma, diabetic ketoacidosis, and death.
  • There is no cure for Type 1 diabetes and insulin treatment must be continued indefinitely.
  • 5-10% of North American diabetics have T1D.

(in Mice)

Mechanism of action of VGX™-1027 against T1D

  • In T1D, pro-inflammatory cytokines, such as TNF-α, interleukin-1 help to destroy the β-cell in pancreas.
  • β-cell destruction causes inhibition of generation and secretion of insulin.
  • This results in T1D.

i "What People With Rheumatoid Arthritis Need to Know About Osteoporosis." November 2006. National Institutes of Health Osteoporosis and Related Bone Diseases.

ii "Rheumatoid Arthritis Market Expected to More than Double in Value to US$27 Billion by 2015". Business Wire. . FindArticles.com. 04 Dec. 2008.

iii "National Diabetes Statistics, 2007". The National Diabetes Information Clearinghouse (NDIC).

iv "DATAMONITOR - Commercial Insight: Inflammatory Bowel Disease." 11/2006. Reference Code: DMHC2260. Page 19.

back to top