October 22, 2002.
Data from a small, 22-patient, open-label, phase II clinical trial of Isis’s (NASDAQ:
ISIS) ISIS-2302 (alicaforsen) has again demonstrated that the antisense construct has a treatment effect in patients with Crohn disease. Recipients can enter disease remission on the drug but the degree to which the rate of remission entry differs from alternative therapy remains uncertain. Isis is currently conducting two, 150-patient phase III clinical trials of ISIS-2302 in patients with Crohn disease that will address the magnitude of relative therapeutic effects.
The data presented at the 67th Annual Scientific Meeting of the American College of Gasteroenterology showed that 13 of 22 patients (59%) achieved a clinical response as measured by a standard, disease-specific tool. 9 of the 13 responders (41% total participants) achieved clinical remission. 5 of these 9 achieved complete remission. Higher doses of ISIS-2302 were used in this trial than for previous investigation. In this trial, non-tumor necrosis factor a (TNFa)-targeting drugs were allowed to be co-administered in unmatched fashion.
ISIS-2302 is an antisense inhibitor of intercellular adhesion molecule-1 (ICAM-1), an important mediator of inflammation. ICAM-1 is one of a family of molecules, the cellular adhesion molecules (CAMs) that exist on the surface of nearly every cell in the body. It not only mediates the interaction between specific cell types but also transmits signals into the cells when activated.
ISIS-2302 has been in development for a long time. In December 1999, phase IIb trials suggested a lack of clinical utility in Crohn disease. Development was resumed in October 2000, and limited momentum has been demonstrated. The primary endpoint of the phase III Crohn studies is clinical remission with no increase in medication use or need for surgery. The achievement of clinical remission will depend on standardized measurements of Crohn disease activity. Meeting this primary endpoint appears to be quite a challenge.
ISIS-2302 is also being studied in a topical formulation for psoriasis and in an enema formulation for ulcerative colitis. Retention enema ISIS-2302 generated data demonstrating therapeutic benefit in its phase II clinical trial in patients with active distal ulcerative colitis (UC). The topical formulation needs to demonstrate a more sustained therapeutic response in more patients in the treatment of psoriasis. Isis is considering evaluating the agent in future trials in combination with other psoriatic medications and in other skin diseases.
Our modeling shows that the probability of FDA approval for ISIS-2302 is 35-45% for Crohn disease (phase III), 25-35% for retention enema in ulcerative colitis (phase IIa), and 15-25% in psoriasis (phase II).
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