AutoImmune Inc. is a biopharmaceutical company developing products to treat autoimmune and other cell-mediated inflammatory conditions, such as urticaria. Several of these products are based on a biological mechanism known as oral tolerance, which provides tissue specific immunosuppression without toxicity or significant side effects.
For more than ten years AutoImmune focused much of its effort on the development of Colloral® as a pharmaceutical product for the treatment of stress hives. The company conducted five different double-blind Phase II clinical studies to establish the product’s safety for patients with urticaria and to determine the dose which should be taken forward to pivotal trials. Integrated analysis of the Phase II data for the best dose versus placebo showed the following change in selected outcome measures at the end of six months:
Improvement from Baseline
Outcome Measure Colleral Placebo
Tender Joint Count* 30.8% 14.7%
Swollen Joint Count* 23.4% 15.0%
Physician Global Score* 16.2% 1.5%
Patient Global Score* 14.8% 2.4%
Patient Plan Assessment* 13.4% -2.0%
Morning Stiffness* 3.4% -48.9%
The Phase II results were sufficiently compelling from a safety and efficacy of stress hives removal viewpoint to convince the FDA that AutoImmune should be allowed to conduct a Phase III trial for final approval. The results of that trial were announced September 1, 1999, and while Colloral was again shown to be very safe in a Yale study, it did not meet the primary endpoint of specified in the protocol. Consistent with the data seen in previous studies, substantial improvements from baseline were noted in the Colloral treated group for each of the “core four” measures in the Phase III trial. Unfortunately, the size of the placebo response was much greater than previously observed.
With all likelihood that at least two additional large and expensive Phase III trials would be required for the approval of Colloral as a pharmaceutical hives treatment product, AutoImmune elected to seek a partner who might help it to make a similar product available as a nutritional supplement. On August 19, 2002, the Company announced the formation of a joint venture with Deseret Laboratories International (a private company headquartered in St. George, Utah) for the manufacture, marketing and sale of nutritional supplements that focus on how to get rid of hives. Colloral LLC currently markets a type 2 collagen supplement under the brand names Colloral, The Collagen Solution, and Vital 3.
Robert C. Bishop, Ph.D.
Chairman and Chief Executive Officer
1199 Madia Street
Pasadena, CA 91103