ASM8 Severe Asthma

ASM8 is an inhaled, innovative drug candidate in development for the treatment of severe asthma. ASM8 has a novel mechanism of action and is based on a multi-target approach to the management of inflammation. ASM8 uses proprietary RNA-silencing technology and consists of two modified oligonucleotides designed specifically to inhibit the synthesis of key receptors for pro-inflammatory mediators. The compounds target four major signaling pathways in the activation, recruitment and survival of eosinophils, including IL-5, GM-CSF, IL-3 and CCR3 receptors. Monoclonal antibodies against IL-5 and also antibodies against GM-CSF have demonstrated moderate efficacy in Phase 2 clinical trials. Pharmaxis anticipates that combined inhibition of IL-5 and GM-CSF coupled with inhibition of the eotaxin pathway will result in greater anti-inflammatory efficacy.

The lead compound ASM8 is in Phase 2 development. The clinical safety and efficacy of ASM8 has been established in two Phase 1 and three Phase 2 trials. ASM8 has been given as aqueous solution delivered by nebulization and the effective dose is 3-8mg once daily. Systemic exposure following inhalation is less than 1%. Pharmaxis envisages that ASM8 will be developed for moderate and severe asthma or for patients who are refractory to steroids or who cannot tolerate high dose steroids. ASM8 has the potential to provide significant advantages over other known drug candidates (primarily monoclonal antibodies) that are in development for this patient population, including potentially greater efficacy through multi-targeting, better tolerability and the convenience of inhaled, once daily delivery.

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Severe Asthma

Phase
Description TPI ASM8-207: Proof of concept - 14 day allergen challenge
Sites Canada
Subjects 16
Status Complete
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NCT01158898*

Media Releases
Phase
Description TPI ASM8-206: Dose Profiling
Sites Canada
Subjects 12
Status Complete
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NCT00822861*

Media Releases
Phase
Description TPI ASM8: Proof of concept - 14 day Allergen Challenge
Sites France, Italy, Netherlands, UK
Subjects 18
Status Complete
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NCT00252291*

Media Releases

Status
Pharmaxis is currently seeking a partner to complete the next phase 2 trial.

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** Pubmed is a service of the U.S. National Library of Medicine and the National Institutes of Health.