Antegren is a humanized monoclonal antibody designed to inhibit the migration of immune cells into tissues where they may play a role in causing or propogating an inflammatory response. The company states that it is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. Approximately 2,800 patients have received natalizumab in clinical trials for both Crohn’s disease and MS; headache, fatigue, and nasopharyngitis were the most commonly reported side effects. BioHorizon has currently assigned Antegren a first in class 75/100 innovation status variable score.

Multiple sclerosis is a chronic, debilitating autoimmune disease that affects the brain and spinal cord. MS causes the body to direct antibodies and white blood cells against proteins in the myelin sheath that surrounds the nerves in the brain and spinal cord. This may cause inflammation and areas of scarring on nerves resulting in loss or decrease in function. An estimated 400,000 Americans have MS. BioHorizon utilizes an incident case number of 10, 400 new cases of MS in the U.S. per annum and assigns an 11/100 value to the burden of illness variable.

BioHorizon is currently monitoring 23 emerging technologies for the treatment of Multiple Sclerosis. Of these 23 drugs, Avonex®, Betaseron®, Rebif®, and Copaxone® are already approved for this indication while Antegren is the only Phase III technology currently in the BioHorizon database. Although currently designated as Moderate Impact technology, we feel that the high degree of innovation exhibited by this treatment and the large unmet medical need surrounding MS will result in significant technology impact. Health Services clients should commence preliminary assessment activities within the next quarter and watch for news regarding approval.

Technology Details
Target Disease / Indication: Multiple Sclerosis
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Neurology
Regulatory Status: Phase III
BioHorizon Impact Score: 53/100 – Moderate Impact

It is estimated that in excess of 300, 000 patients are diagnosed with Alzheimer’s disease annually in the United States. Biohorizon assigns Alzheimer’s disease a value of 33/100 for the Burden of Illness variable.

Current approved therapies for Alzheimer’s include Aricept® and Namenda®. Biohorizon is following 43 emerging drug therapies for Alzheimer’s disease. Seven of these therapies are in Phase III or beyond in their development. Neurochem contends that Alzhemed is a novel small molecule part of a new class of therapies that it calls ‘GAG (glycosaminoglycan) mimetics’. Glycosaminonglycans are thought to play a role in the formation of amyloid plaques. In theory, interrupting the assembly of these plaques could alter the clinical course of disease. This unique approach earns Alzhemed an Innovation score of 75/100.

If approved, Alzhemed would represent a first in class therapy for a common, chronic disease. We see potentially significant demand and diffusion pressures, but at this time have assigned a 10/100 score to the Predicted Demand/Diffusion variable. Overall, Alzhemed is placed in Biohorizon’s Moderate Impact Technology category with an Impact Score of 51/100. We do not recommend any preliminary assessment activities for our health services clients at this time; however, favorable Phase III results could dramatically alter this position.

Technology Details
Target Disease / Indication: Alzheimer’s Disease
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Neurology
Regulatory Status: Phase III
BioHorizon Impact Score: 51/100 – Moderate

The purpose of the double-blind, placebo-controlled study is to evaluate the efficacy and safety of dexanabinol as a neuroprotectant agent in severe TBI patients. Enrolled patients were given a single dose of 150mg dexanabinol or placebo within six hours after injury and received the standard care normally provided to TBI patients in intensive care units. The primary endpoint for the study will be patient outcome as measured on the Glasgow Outcome Scale – Extended (GOSE) six months after injury.

Physical trauma to the brain triggers a complex network of cascades that produce neuronal damage and death far beyond that caused by the initial insult. Dexanabinol, a tricyclic dextrocannabinoid, is thought to exert its neuroprotective effect through three mechanisms of action that suppress these toxic and inflammatory cascades induced by TBI: the inhibition of NMDA stimulated calcium influx, the inhibition of TNF alpha and other inflammatory cytokines, and free radical scavenging.

Annually in the United States, there are about two million emergency room visits for head injury, about 300,000 admissions for head trauma, and approximately 52,000 deaths. According to Pharmos Corporation, the annual market potential for a drug treating new TBI victims in the U.S. is over $500 million. Currently, there is no FDA approved product for the treatment of severe head injury.

Dexanabinol remains a Moderate Impact Technology in the Biohorizon Emerging Health Technology Database, with no assessment activities recommended at the present time for clients operating trauma programs. However, Dexanabinol has the potential to transform the management of patients with severe TBI and as such should be monitored closely over the coming months.

Technology Details
Target Disease / Indication
Traumatic Brain Injury

Technology Classification
Drug

Body System
Nervous System

Program Area
Medicine/Neurology

Regulatory Status
Phase III

BioHorizon Impact Score
51/100 – Moderate