Aridis Pharmaceuticals applying proprietary technologies to curate novel anti-infectives and immunotherapies for infectious diseases proclaimed that it has created a Joint Venture with Shenzhen Hepalink Pharmaceutical Group , one of China’s leading pharmaceutical companies to develop and gain regulatory approval for Aridis’ fully human monoclonal antibody therapies for the market in China.
The jointly owned subsidiary company will be denoted Shenzhen Arimab Bio-pharmaceuticals headquartered in China’s tech hub, Shenzhen. The company will be launched with remarkable commitment to advance two of Aridis’s clinical candidates namely AR-301 and AR-101 through potential China FDA approvals in acute pneumonia caused by Gram-positive Staphylococcus aureus and Gram-negative Pseudomonas aeruginosa infection.
Aridis and Hepalink are actively collaborating on clinical and regulatory strategies to include major hospital centers in China as part of global pivotal trials for these two assets.
Vu Truong, Ph.D., Founder and CEO of Aridis stated “As in many countries across the world, antibiotic resistance is a rapidly growing problem in China because of overuse of broad-spectrum antibiotics. There is a strong need for new, innovative anti-infectives to stem the tide of resistance and expand treatment options in the sizable Chinese market. We believe our AR-301 and AR-101 mAbs, two of the world’s most advanced immunotherapies addressing severe bacterial infections, may serve as major technological advancement for treating life-threatening infections such as bacterial pneumonia.”
AR-301 which is a human IgG1 mAb that primarily targets S. aureus alpha-toxin and protects host cells form toxin-dependent destruction by repressing functional toxin pore formation. Mode of action is independent of the antibiotic resistance profile of S. aureus, therefore it is active against infections caused by both MRSA and MSSA. Phase 2a clinical trial of AR-301 as an adjunct therapy to standard-of-care antibiotics in patients with severe hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) caused by S. aureus, patients experienced no related serious adverse events at any AR-301 dose level and compared to antibiotic treatment alone, patients treated with AR-301 at all dose levels spent a shorter time under mechanical ventilation.
AR-101 is a highly specific mAb targeted against P. aeruginosalipopolysaccharide serotype O11, which accounts for ~20% of all P. aeruginosa hospital-acquired infections worldwide and higher incidence in China. It is intended to be a first-line adjunctive therapy for patients with severe P. aeruginosa pneumonia being treated in intensive care units and has Orphan Drug designation from the U.S. FDA and Europe’s EMA regulatory agencies.