AZTherapies has announced the initiation of a Phase 2a clinical trial of its ALZT-OP1a inhaled cromolyn in patients with mild- to moderate-stage amyotrophic lateral sclerosis (ALS). The randomized open-label trial is expected to enroll 80 ALS patients who will receive, in addition to standard of care, either 17.1 mg of cromolyn via DPI twice a day or 34.2 mg twice a day over 12 weeks.
In October 2019, AZTherapies said that it had raised over $26 million for completion of a Phase 3 trial of ALZT-OP1 for Alzheimer’s and for development of other candidates, including inhaled cromolyn for the treatment of post-ischemic stroke cognitive impairment and for ALS. The phase 3 trial of dry powder ALZT-OP1a/oral ALZT-OP1b (ibuprofen) for early stage Alzheimer’s disease was initiated in 2015.
The company’s scientific advisory board chair, Rudolph Tanzi of Massachusetts General Hospital, said, “In our pre-clinical evaluations, ALZT-OP1a demonstrated the ability to delay disease onset and progress, reduce motor deficits, and reduce pro-inflammatory cytokine/chemokine levels in the spinal cord and plasma of mice. I will be following the progress of this trial with great interest.”
AZTherapies CEO and Chairman David Elmaleh commented, “With a strong unmet medical need and mounting evidence that neuroinflammatory processes are implicated in the initiation and progression of ALS, we are excited to explore the use of ALZT-OP1a in ALS patients for the first time. We have been able to progress this program rapidly from bench to bedside based on comprehensive pre-clinical work and are optimistic that we will see clear safety and efficacy signals from this clinical trial. We believe this is not only a significant step forward for us, but, more importantly, for the many ALS patients with so few treatment options.”
Read the AZTherapies press release.
