Expanded Access for MEM-ANT3310
Antabio is a clinical-stage biopharmaceutical company developing novel antibacterials targeting drug-resistant pathogens that are deemed a critical priority by the WHO. The company’s lead drug candidate is MEM-ANT3310, which is currently in development for the treatment of infections suspected or proven to be caused by MDR Gram negative pathogens, including CRE and CRAB. This development is being conducted, among others, through clinical trials. If successful, these studies may provide the basis for drug approval by regulatory authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Details about these clinical trials, including eligibility requirements for participating in ongoing or planned studies, are published in public databases such as clinicaltrials.gov and clinicaltrialsregister.eu.
We recognize that in other indications patients may be seeking access to investigational drugs via compassionate use or expanded access before the regulatory approval of a drug. However, for the treatment of some acute infections, effective antibiotic therapy needs to be initiated very soon after onset of symptoms, and therefore, timely emergency access may not be possible. Although MEM-ANT3310 may offer antimicrobial coverage for more and different pathogens than existing therapies, each identified pathogen could typically still be treated by some approved antibiotic. Therefore there is no urgent unmet medical need to offer access via compassionate use or expanded access to MEM-ANT3310 prior to completion and evaluation of the safety and efficacy studies. Furthermore, providing access outside of controlled clinical trials at this time could jeopardize the conduct of these trials or prevent or delay access to MEM-ANT3310 for other patients in need.
In summary, at this point in time Antabio does not provide access to MEM-ANT3310 outside of Antabio’s clinical trials. This policy may be reviewed and amended in the future. For additional information about this policy, please contact info@antabio.com. We aim to provide responses within ten working days.
