Date: 2017-02-14
Type of information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
Company: Allergy Therapeutics (UK)
Product: Acarovac MPL (monophosphoryl lipid A)
Action
mechanism: immunotherapy product. Acarovac MPL is a house-dust mite immunotherapy in development utilising MCT® (microcrystalline tyrosine), a natural, biodegradable depot, and the adjuvant MPL for the treatment of perennial allergic rhinitis.
Disease: house dust mite allergy
Therapeutic area: Allergic diseases
Country: Spain
Trial details:
Latest
news: * On February 14, 2017, Allergy Therapeutics announced that the Phase I clinical study investigating the safety and tolerability of Acarovac MPL (monophosphoryl lipid A) has received Clinical Trial Application (CTA) approval in Spain. CTA approval has been granted and the Company now expects this formulation to begin Phase I studies immediately, to assess the safety and tolerability of two different dose regimens. Both treatment regimens include a two-to-four week initial up-dosing phase but differ in the duration of the later maintenance phase. The Phase I trial of 32 patients is expected to last one year, and to be delivered on-time in-line with the Company's stated strategic plan when funding the programme in November 2015. If the Phase I trial is successful, the Company expects to launch Acarovac MPL in Spain on a named-patient basis.
