FDA Grants Fast Track Designation for C Diff Treatment

FDA has granted Fast Track designation for ACX-362E, an investigational new treatment for C diff that is being developed by Acurx Pharmaceuticals, LLC.

The US Food and Drug Administration (FDA) has granted Fast Track designation for ACX-362E, an investigational new treatment for C diff that is being developed by Acurx Pharmaceuticals, LLC.

ACX-362E is a targeted, narrow-spectrum orally administered antibacterial that is being evaluated in a recently launched phase 1 clinical trial. The antibiotic is one of multiple DNA polymerase IIIC inhibitors that Acrux is developing to treat bacterial infections.

"If approved, we believe our new antibacterial, ACX-362E, will be an important therapeutic alternative for patients with [C diff]. The Fast Track designation will allow Acurx to work more closely with the FDA to bring ACX-362E to physicians and patients as soon as possible." Robert J. DeLuccia, Co-Founder and Managing Partner of Acurx, said in a statement.

ACX-362E acts as a DNA polymerase inhibitor. According to the company, the mechanism of action has been established as the selective inhibition of the enzyme DNA polymerase IIC. The enzyme is responsible for bacterial replication and pathogenesis in several Gram-positive bacteria which include C diff, Enterococcus, Staphylococcus, and Streptococcus.

"FDA's granting of Fast Track designation for our lead antibiotic program validates our business model which includes a pipeline of DNA polymerase IIIC Inhibitors we are currently developing to treat other resistant bacterial infections,” David P. Luci, Co-Founder & Managing Partner of Acurx said in the statement.

ACX-362E was classified as a Qualified Infectious Disease Product (QIDP) for the treatment of C diff by the FDA in June 2018. The designation grants the antibiotic eligibility for certain benefits and incentives in the development process under the Generating Antibiotic Incentives Now Act (the GAIN Act), which includes FDA Priority Review.

The company anticipates that the phase 1 clinical trial will be completed during the second quarter of 2019. A phase 2 clinical trial is planned to begin in the fourth quarter of 2019.

Current estimates by the US Centers for Disease Control and Prevention (CDC) indicate that approximately 500,000 patients per year are treated for C diff in the US. Additionally, approximately 20-30% of patients experience recurrence due to limited treatment options.

C diff is also a threat in Canada, Europe, and parts of Asia. Acrux has indicated that the company anticipates development and commercialization of the candidate in these countries as well.

According to the CDC, C diff infection risk is higher in individuals over the age of 65 who are receiving medical care and taking antibiotics; individuals in long-term healthcare, and immunocompromised individuals.