AZTherapies announced that it has initiated a Phase 3 study of its ALZT-OP1 DPI for the treatment of early stage Alzheimer’s disease. ALZT-OP1 is a dry powder formulation of cromolyn and ibuprofen that is delivered by a proprietary inhaler called Azhaler-D; AZTherapies licensed the technology from Massachusetts General Hospital.
The company said that it plans to be recruiting patients in “more than 10” countries by the end of the year and that it “has reached a broad agreement” with the FDA that it could eventually submit a 505(b)(2) NDA.
AZTherapies founder David R. Elmaleh commented, “Confronting two triggering causes associated with Alzheimer’s disease progression simultaneously provides a new multifunctional treatment approach for modifying disease progression. Very early intervention, in subjects with the earliest clinical signs of dementia due to AD, will be key in preventing and/or delaying the onset of dementia, the in-vitro, in-vivo, and the pharmacokinetic data support the potential for halting disease onset and progression.”
Read the AZTherapies press release.
