Allergy Therapeutics announced positive Phase I safety and tolerability results of its subcutaneous Acarovac MPL (Monophosphoryl Lipid A). The results were in patients with house dust mite-induced allergic rhinoconjunctivitis.
The primary endpoint, which was met, was the safety and tolerability of 7 injections of Acarovac MPL administered over 6-12 weeks each 1-2 weeks apart.
A secondary endpoint of the study included the vaccine's effect on patients' responses to nasal provocation test - a test in which the nose is exposed to the substance that causes the allergy – in this case dust mites.
The formulation was found to be well tolerated, the safety profile was satisfactory and the reported adverse events were consistent with what have been observed with similar formulations of allergy vaccines.
The success of our clinical trial in house dust mite-induced allergic rhinitis is “encouraging news for the many patients who continue to suffer with the symptoms caused by house dust mite allergy, and supports our ambition to provide a global therapy for the important US, China and EU markets,” commented Manuel Llobet, chief executive officer of Allergy Therapeutics.
He continued, “Based on the unique triple-combination of our allergoids, and the adjuvant system MPL and MCT we believe Acarovac MPL could build on our success in dust mite immunotherapy and we look forward to progressing towards phase II clinical studies.”
Acarovac MPL is a subcutaneous immunotherapy product containing Dermatophagoides pteronyssinus and Dermatophagoides farinae allergoids adsorbed to the adjuvant system comprised of MCT (Microcrystalline Tyrosine) and MPL.