GENEVA, Switzerland I March 29, 2018 I Combioxin SA announced today the completion of the first-in-man CAL02-001 clinical study (https://clinicaltrials.gov/ct2/show/NCT02583373). This was a randomized, multicentre, double-blind, placebo-controlled study designed to assess the safety and tolerability of CAL02 in severe community-acquired pneumonia due to Streptococcus pneumoniae as well as exploring efficacy and pharmacodynamics parameters. This study included two CAL02 dosing regimens. An Independent Data Monitoring Committee unanimously supported a positive safety profile of CAL02 at both regimens.

CAL02 neutralizes pathogens’ released toxins that play a key role in the development of severe and fatal complications. CAL02 is at the forefront of combination therapies that aim to dramatically improve the treatment of severe and resistant infections, when toxins prompt a tremendous detrimental cascade and time for intervention is critical. CAL02, a broad-spectrum agent is active against both Gram-positive and Gram-negative bacteria, including those commonly associated with antimicrobial resistance. It acts regardless of the resistance profile of the target pathogen and does not elicit the emergence of resistance.

Jeffrey B. Jump, Chairman of Combioxin, commented: “We are pleased that the CAL02-001 study is completed and looking forward to sharing results in the coming months. We are now planning initiation of the Phase 2 study which we believe will confirm the full potential of CAL02.”

“There is an urgent need for new treatments operating in synergy with antibiotics to improve first-line standard of care and overturn mortality associated with severe infections” said Dr. Toni Perez, Combioxin’s Chief Medical Officer.

About Combioxin

Combioxin SA is based in Geneva, Switzerland and specialises in the treatment of severe bacterial infections. The company is a recipient of the Swiss FIT SEED programme and a member of the BEAM Alliance.