Pipeline

Altoderm

Altoderm™ for Atopic Dermatitis

Altoderm is a topical formulation of cromolyn sodium, a non-steroidal, anti-inflammatory agent that has a long history of use in treating allergic inflammatory diseases such as asthma and allergic rhinoconjunctivitis.  Cromolyn sodium is a mast cell stabilizer that decreases mast cells’ release of inflammatory agents such as neurotransmitters, cytokines, and histamines.  Elevated levels of these agents result in local and systemic inflammation that, in turn, leads to conditions such as atopic dermatitis.  By reducing the release of inflammatory agents by mast cells, Manhattan Pharmaceuticals believes that Altoderm may effectively treat pruritus (itching) associated with atopic dermatitis and other pruritic conditions.

Topical steroids, topical immunomodulators, systemic antihistamines, and moisturizing agents are currently the primary pharmaceutical treatments for atopic dermatitis.  However, these products are not meeting the needs of patients due to unwanted side effects including skin thinning, acne, hypopigmentation, and secondary infection, among other, and limited evidence to support their long term safety.  Based on these limitations of current atopic dermatitis treatments, there is a significant market opportunity for new, effective therapies.

In a previously completed European Phase 3, randomized, double-blind, placebo-controlled, clinical study of Altoderm conducted by Thornton & Ross Limited, the compound demonstrated a statistically significant reduction (36%) in symptoms in moderately severe atopic dermatitis.  During the study, subjects were permitted to continue with their existing treatment, in most cases this consisted of emollients and topical steroids.  A positive secondary outcome of the study was a statistically significant reduction in the use of topical steroids for the Altoderm-treated subjects.  Further analysis also revealed that Altoderm-treated subjects experienced a 57% improvement in pruritus.  A second European Phase 3 study of Altoderm, also conducted by Thornton & Ross Limited is currently ongoing.

On March 6, 2008, Manhattan Pharmaceuticals announced it had successfully completed a pre-IND meeting with the FDA.  Based on a review of the submitted package for Altoderm, including data from the two previously reported Phase 3 clinical studies, the FDA determined that following completion of certain nonclinical studies, and the acceptance of an IND, Phase 2 clinical studies may be initiated in the U.S.  The FDA also concurred that the proposed indication of pruritus associated with dermatologic conditions including atopic dermatitis can be pursued.