Conduit secures US patent for potential AAV therapy AZD1656
Company says it's positioned to advance treatment to clinical development
The U.S. Patent and Trademark Office (USPTO) has granted Conduit Pharmaceuticals a patent for AZD1656, its experimental therapy for ANCA-associated vasculitis (AAV) and other autoimmune diseases.
The USPTO granted a composition of matter patent, which is a type of patent that relates to novel compounds made from two or more different substances. This type of patent is classified as a drug substance patent by the U.S. Food and Drug Administration (FDA), and it gives Conduit up to 20 years of intellectual property protections for AZD1656.
“Securing USPTO approval for AZD1656’s composition of matter patent is a major milestone, further solidifying our intellectual property portfolio and strategic value,” David Tapolczay, CEO of Conduit, said in a company press release. “With the composition of matter patent now in place in this critical market, this also indicates an increased likelihood of patent success in the outstanding additional geographies worldwide.”
Patent applications for AZD1656 have been approved in Japan and Australia, and are pending in Europe and other markets, according to the company.
USPTO’s decision makes Conduit “strategically positioned to advance AZD1656 into clinical development, with clinical trial plans now in final stages of preparation,” the company said. Conduit last year announced plans for two placebo-controlled Phase 2 trials in people with AAV or lupus.
AAV therapy activates blood sugar-related protein
Autoimmune diseases such as AAV and lupus are marked by immune responses that wrongly target the body’s own healthy cells and tissues, causing inflammation and cell damage and death. AAV is characterized by inflammation in small blood vessels.
AZD1656 is an oral therapy that works to activate glucokinase, a protein that plays a central role in how the body’s cells process blood sugar, the body’s main energy source. The therapy was originally developed by AstraZeneca for diabetes, though its ability to help diabetic patients control blood sugar levels was lackluster in clinical trials.
Conduit acquired rights to AZD1656 last year. The company is exploring the therapy’s potential in autoimmune diseases based mainly on data from a Phase 2 trial called ARCADIA (NCT04516759), which tested AZD1656 against a placebo in adults with diabetes who were hospitalized due to COVID-19.
The ARCADIA study hoped to show that the experimental therapy was better than a placebo at leading to clinical improvement, but results showed no significant differences in that outcome between the AZD1656 and placebo groups.
Data did suggest that AZD1656-treated patients had a less pro-inflammatory immune response than those given the placebo. According to Conduit, these results support a potential immunosuppressive effect of the therapy, indicating that AZD1656 may be useful to treat autoimmune diseases.
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