Conduit to move AZD1656 into clinical trials for AAV, lupus
Therapy repurposed after showing 'potential' in autoimmune diseases
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Conduit Pharmaceuticals is planning to launch Phase 2a clinical trials to test its lead oral candidate AZD1656 in people with immune system disorders — specifically ANCA-associated vasculitis (AAV) as one indication.
“With its potential to become a first-in-class therapy for autoimmune diseases, AZD1656 represents a significant leap forward in our mission to develop ground-breaking treatments that could transform the landscape of autoimmune care and provide innovative treatments that can truly make a difference to patients,” Freda Lewis-Hall, MD, chair of Conduit’s board of directors, said in a company press release.
In addition to AAV, the company plans to initiate a Phase 2a study of AZD1656 for systemic lupus erythematosus, the most common form of another autoimmune disease called lupus.
In both upcoming trials, the experimental oral therapy will be tested against a placebo. No further details on the study designs or locations were disclosed.
The plans build on previous Phase 2b clinical data of AZD1656 as a potential treatment for diabetes; that clinical program was sponsored by AstraZeneca, the therapy’s original developer.
AZD1656 will be tested in Phase 2a clinical trials for AAV and lupus
Licensed exclusively to Conduit earlier this month, AZD1656 has been tested in more than 1,000 patients across nearly two dozen clinical trials. Besides showing a favorable safety profile, AZD1656 appears to play a role in controlling unwanted immune responses.
Against this backdrop, Conduit, which now has rights to the therapy for all human indications, is repurposing it for autoimmune diseases, given its potential to balance the immune response and reduce inflammation.
“Having reviewed the extensive data, we are delighted to advance AZD1656 into a new therapeutic area targeting systemic lupus erythematosus and ANCA-associated vasculitis,” Lewis-Hall said.
Like other autoimmune diseases, AAV and lupus occur when the immune system produces antibodies that mistakenly react against the body’s own cells. In AAV, these self-reactive antibodies specifically prime a type of immune cells called neutrophils against small blood vessels, causing them to become inflamed and damaged.
Having reviewed the extensive data, we are delighted to advance AZD1656 into a new therapeutic area targeting systemic lupus erythematosus and ANCA-associated vasculitis.
Both single-dose (up to 180 mg) and multiple-dose (150 mg twice a day) regimens were tested over eight days in healthy volunteers. In people with diabetes, who have abnormally high blood glucose levels, AZD1656 has been tested at up to 200 mg daily, either alone or in combination with other glucose-lowering medications.
No serious side effects were noted in healthy volunteers or patients, according to AstraZeneca.
Now, Conduit will further test the therapy candidate in clinical trials, but with a focus on treating AAV and lupus as initial indications.