Athenex Announces FDA Allowance of Investigational New Drug Application of Eribulin ORA to Begin Clinical Trials

Athenex (Nasdaq:ATNX) a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, announced that the FDA has allowed the Investigational New Drug (IND) application for Athenex’s oral version of Eribulin currently named Eribulin ORA.

As quoted in the press release:

This FDA action allows Athenex to commence its clinical trial program, currently planned for first half of 2019.  Eribulin, an effective treatment for metastatic breast cancer and liposarcoma, is currently limited to intravenous administration.  Utilizing Athenex’s proprietary Orascovery platform with Eribulin, we were able to demonstrate that good oral absorption of Eribulin is possible, based on preclinical studies. In addition, the Eribulin active pharmaceutical ingredient (API) has been developed internally using a novel synthetic approach. We believe these developments demonstrate the broad utility of the Orascovery platform and commitment of Athenex to becoming a major global oncology biopharmaceutical company.

Dr. Michael Smolinski, Athenex’s Head of Preclinical Research, commented, “Athenex is delighted that the FDA has allowed the IND of Eribulin ORA.  The demonstration of a favorable pharmacokinetic profile, with lowered peak plasma concentration and longer duration of the drug within the desired plasma concentration range, provides the potential for a better efficacy and an improved safety profile for Eribulin, similar to what we have observed with Oraxol (oral form of paclitaxel) and others. We have also developed a novel and efficient synthetic process for Eribulin with an excellent purity profile. This is the eighth US IND allowance that Athenex has obtained, reflecting the passion and dedication of the company to bringing new therapies to cancer patients.”

Click here to read the full press release.