Ascomycin--just around the corner...maybe!

[Guest guest]

Hi everyone,

I thought you might be interested in this article--it talks about one

of the future topicals Dr. Nase mentioned in his book, one he thought

would be promising and an alternative to dangerous corticosteroids.

Marie

AAD: Ascomycin Macrolactam, ASM 981 Cream 1% (Pimecrolimus) Promising

in Eczema Treatment

WASHINGTON, DC -- March 5, 2001 -- Data presented at the 59th Annual

American Academy of Dermatology (AAD) meeting support the potential

use of an ascomycin macrolactam, ASM 981 cream 1% (pimecrolimus), a

selective inflammatory cytokine inhibitor, as first-line treatment

for mild to moderate pediatric atopic dermatitis. These pivotal Phase

III pediatric trials present results regarding the safety and

efficacy of ASM 981 in patients as young as two years of age.

Atopic dermatitis (commonly known as eczema) can be both physically

and emotionally devastating. The effects of this condition are

particularly prevalent and distressing in young children. The

potential for a new safe and effective therapy for use in pediatric

patients would represent a significant step forward. The disease

develops within the first year of life in half of the cases, with an

additional 30 percent being diagnosed between one and five year of

age. Studies from Europe, Japan and the U.S. have identified atopic

dermatitis as a major public health problem.

" Given the substantial degree of concern over the use of

corticosteroids in young patients there is a real need for treatment

alternatives. These data provide strong support for ASM 981 as a

potential new treatment, " commented Dr. Jon Hanifin, Oregon Health

Sciences University, Portland, Oregon. " Health professionals await

the availability of ASM 981, which may provide them with a new option

for pediatric patients who currently suffer significantly from the

distressing effects of atopic dermatitis. "

Data from three key pediatric trials investigating ASM 981 cream 1%

were presented at the AAD meeting, including two studies focusing on

the efficacy and safety of ASM 981 and one pharmacokinetic study that

reported on the low blood concentrations of ASM 981 in infants (three

to 23 months) with atopic dermatitis who were treated with

medications over extensive body surface areas.

Two of the three studies were identical multicenter, vehicle-

controlled trials, evaluating the short-term efficacy and safety of

ASM 981 cream 1%. The studies were completed in patients aged two to

17-years old, and both studies consisted of a six-week randomized,

multicenter, double-blind, parallel-group phase followed by a 20-week

open-label phase. Only the six-week double-blinded data were

presented at the meeting.

The combined results of these two studies show the superior efficacy

of ASM 981 cream 1% over vehicle. Significant efficacy, as assessed

by the Investigators Global Assessment (IGA) scale, was evident as

early as the first study visit (Day eight). By the end of the six-

week, double-blind phase, the percent of patients who rated clear or

almost clear (IGA = 0 or 1) was significantly greater in ASM 981

patients than vehicle patients. ASM 981 treated patients showed a

significantly greater reduction in the extent and severity of disease

signs compared to the vehicle group as early as Day eight. The

treatment effect continued throughout the course of the study.

Pruritus (itching), the hallmark symptom of atopic dermatitis, was

assessed. By Day eight, there was a significantly greater percent of

ASM 981-treated patients with absent or mild pruritus than vehicle-

treated patients. That difference continued to grow over the

treatment course. Local tolerability was comparable between treatment

groups as shown by the low incidence of application site burning (10

percent ASM 981 compared to 13 percent vehicle).

The third study was a pharmacokinetic study in infants aged three to

23 months with extensive atopic dermatitis designed to investigate

the systemic exposure and clinical tolerability of ASM 981 cream 1%.

Results of the study demonstrated that three weeks' treatment over

large body surface areas involved with atopic dermatitis resulted in

very low blood concentrations, with the majority below the limit of

quantitation. In addition, patients exhibited good local and systemic

tolerability. Dr. Jon Hanifin commented on the results,

saying, " These results demonstrate low blood concentrations of ASM

981 in infants, which is particularly encouraging given that safety

is a primary concern in this population. " Additional efficacy and

safety trials with ASM 981 cream 1% in infants are currently underway.

ASM 981 is a selective inflammatory cytokine inhibitor being

developed by Novartis Pharmaceuticals Corporation and represents a

new class of steroid- free potential treatments for atopic

dermatitis. ASM 981 is being studied specifically for the treatment

of inflammatory skin disorders and, if approved by the FDA, will be

one of the first new treatment options for atopic dermatitis in 40

years.