Make Concerted Efforts and Struggle Together - Phase III clinical trial of XNW4107, a new-generation β-lactamase inhibitor in Evopoint, has been approved in China
On September 14, Suzhou Evopoint Biosesciences Co., Ltd.(hereinafter referred to as Evopoint) received the Notice of Drug ClinicalTrial Approval (acceptance No. CXHL2200420) issued by the State Food and DrugAdministration, which approved a Phase III clinical trial of XNW4107 combinedwith Imipenem/Cilastatin Sodium for hospital-acquired bacterial pneumonia(HABP) and ventilator-associated bacterial pneumonia (VABP) caused bygram-negative bacteria. Meanwhile, XNW4107 has been approved by FDA as a keytherapeutic protocol in a Phase III clinical trial for the same indicationspreviously in April 2022.
XNW4107, with independent intellectual property rightsowned by Evopoint, is a novel agent with broad-spectrum activity againstβ-lactamase-producing strains, which is applicable to carbapenem-resistantbacterial infections that has an increased incidence in recent decades, such ascarbapenem-resistant Acinetobacter baumannii (CRAB), carbapenem-resistantPseudomonas aeruginosa (CRPA), carbapenem-resistant Enterobacteriaceae (CRE),etc. XNW4107 combined with Imipenem/Cilastatin (β-lactam antibiotics) has astrong antibacterial effect, and this protocol has received QualifiedInfectious Disease Product (QIDP) designation and Fast Track designation (FTD)certification from FDA of the United State in January 2021. This approval toconduct Phase III clinical trail fully demonstrates that this product has beenrecognized by CDE. In the near future, Evopoint will officially launch a key international multi-center Phase III clinical trial on XNW4107, whichwill be carried out in over 100 Research Centers worldwide, including China,the United States and some European countries.
Bacterial resistance presents a major public healthchallenge of global concern. In a study published recently, about 1.27 millionpeople worldwide died of bacterial resistance in 2019. If this problem cannotbe solved, it is estimated that by 2050, about 10 million people will die ofbacterial resistance every year. The World Health Organization (WHO) has listedCRE, CRPA and CRAB as drug-resistant bacteria that pose serious threats tohuman health. It is urgent to develop new-generation therapeutic agents withactivities against drug-resistant bacteria as an effective solution. XNW4107,an innovative β-lactamase inhibitor with independent intellectual propertyrights owned by Evopoint, is specifically targeted to bacterial resistance,which can be an available solution for the problem that the existingβ-lactamase inhibitors are ineffective for CRE, CRPA and CRAB. XNW4107 exhibitsan effective in vitro inhibitory effect on OXA β-lactamase (acting asthe main mechanism of CRAB). However, products of the same category that areavailable on the market or are under development all lack the inhibitoryactivities against OXA.
Mr. Meijie Le, CEO of Evopoint, has declared that accordingto a series of in vitro antimicrobial susceptibility testing and studieson infections in animal models in vivo, XNW4107, combined with Imipenemand Cilastatin, has an excellent antibacterial activity against the three majorcarbapenem-resistant bacteria issued by WHO that need to be addressed urgently.It is the unique broad-spectrum β-lactamase inhibitor currently available onthe market with strong antibacterial activity against major drug-resistantbacteria, with a good competitive landscape and significant productdifferentiation. Mr. Le Meijie said that “XNW4107 is a β-lactamase inhibitorwith independent intellectual property rights owned by Evopoint. It has anexcellent antibacterial activity when combining with Imipenem and Cilastatinagainst the three major carbapenem-resistant bacteria that need to be addressedurgently. This agent has a wide range of applications and huge market potentialin the near future. XNW4107 has now been involved a Phase III clinical trial inthe United State and been approved successively in China, which will acceleratethe performance of international multi-center trials. We believe that ifXNW4107 is successfully approved and commercialized in the future, it isexpected to bring active return to Evopoint, offer better solutions formultiple bacterial resistance, and benefit numerous sufferers.”
