Neuren Pharmaceuticals (ASX: NEU) today reported that its partner for trofinetide, Acadia Pharmaceuticals (Nasdaq: ACAD), has secured an extension of US patent protections for the drug until March 2041. Neuren Pharmaceuticals is developing new drug therapies to treat multiple serious neurological disorders caused by genetic abnormalities or brain injury, that have no or limited approved treatment options. Its therapies target the critical role of Insulin-like growth factor 1 (IGF-1) in the brain, using orally administered analogs of naturally occurring peptides. Acadia Pharmaceuticals announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a US patent application covering weight-banded dosing of trofinetide for the treatment of Rett syndrome.
The Notice of Allowance relates to U.S. Patent Application No. 17/590,496, titled “Methods and Compositions for Treatment of Rett Syndrome.” Following the completion of standard administrative steps, the patent is anticipated to issue. Once issued, and including six months of pediatric exclusivity, this new patent is expected to provide protection for trofinetide in the United States through March 28, 2041. This represents an extension of almost five years beyond the existing method of use patent for trofinetide in Rett syndrome, which currently expires in July 2036.
Trofinetide, developed under an exclusive worldwide license to Acadia Pharmaceuticals, is currently marketed in the United States as DAYBUE® and DAYBUE® STIX. These formulations are approved by the US Food and Drug Administration (FDA) for the treatment of Rett syndrome in adults and pediatric patients aged 2 years and older. The allowance of this patent underscores the intellectual property strength surrounding the specific weight-banded dosing regimen integral to the administration of this therapy.
