NEWS | BEAM Alliance


Combioxin SA announces that it has received positive feedback from FDA on its preinvestigational new drug application (PIND) for use of CAL02 in COVID-19 patients at high risk of secondary bacterial infections.

Geneva, Switzerland, 04 May 2020 – Combioxin SA, a clinical-stage biotechnology company dedicated to the development of first-in-class life-saving drugs for severe infections, announced today that the U.S. Food and Drug Administration (FDA) has favorably reviewed the compan’s PIND application for CAL02. The review was conducted within the framework of the Coronavirus Treatment Acceleration Program (CTAP), FDA’s expedited process for possible therapies to treat COVID-19 patients as quickly as possible.

The COVID-19 pandemic is exerting tremendous pressure on intensive care units (ICUs). Secondary bacterial infections are observed in a substantial number of critically ill COVID-19 patients and represent a leading cause of death. Co-infections also extend further the duration of intensive care management. In the majority of these cases, co-infected ICU patients suffer from increasingly severe and potentially fatal complications, which occur whether bacteria are eventually cleared by antibiotics or not. Based on guidelines for the management of viral pneumonia with respiratory failure, critically ill COVID-19 patients receive early administration of empirical antibiotics to prevent and treat suspected or confirmed secondary bacterial pneumonia, which inevitably amplifies the risk of increased resistance to commonly-used antibiotics.

We are extremely satisfied with the positive feedback provided by the FDA for the clinical development of CAL02 in COVID-19 patients. Without any required additional pre-clinical work, we plan to assess CAL02 versus placebo in its ability to prevent and treat secondary bacterial infection complications’, said Dr. Toni Perez, Combioxin’s Chief Medical Officer.

Our objective is to improve the recovery of critically ill COVID-19 patients and save their lives. The positive feedback from the FDA is meaningful encouragement towards the development of CAL02 for this goal‘, said Dr. Samareh Azeredo da Silveira Lajaunias, co-founder and General manager of Combioxin. ‘Based on our preliminary results with enveloped viruses, this trial will also offer a chance to assess the anti-viral potential of CAL02 and we are working around the clock to accelerate our program in this new setting.’

Full PR available here