Carbon Cloud PeptiPharma's AI-Designed Antimicrobial Peptide iCAMP016 Receives NMPA IND Approval for Bacterial Vaginosis

On December 17, 2025, iCarbonX All independently built “AI Technology + Peptide Chip"A Class 1 New Chemical Drug Developed by the Integrated Platform——Antimicrobial Peptide iCAMP016 Vaginal Gel, has officially received clinical trial approval from the National Medical Products Administration (NMPA) for the proposed treatment of bacterial vaginosis. Previously, the company successfully completed an out-licensing collaboration for its GLP-1R/GIPR/GCGR triple agonist project. The IND approval of iCAMP016 marks a significant transition of the company’s innovative drug pipeline from the preclinical stage to the clinical stage, achieving a crucial leap from technical validation to clinical translation.

iCAMP016 is an innovative achievement developed by iCarbonX All based on its core AI algorithms and the high-throughput peptide chip InteraCtX™ digital molecular technology platform, through efficient screening, synthesis, and optimization. This project is supported by Shenzhen's major scientific and technological special project (Key Project 202405018: Key technology research and development of antimicrobial peptide drugs based on AI technology combined with a peptide chip platform, Project No.: KJZD20240903103500002). The drug rapidly disrupts biofilm structures by targeting key phospholipid components of pathogenic microbial cell membranes, achieving highly effective sterilization.

Preclinical studies have shown that iCAMP016 can specifically target and rapidly disrupt the biofilm structure of pathogenic microorganisms, including clinically isolated Gardnerella and MRSA (methicillin-resistant Staphylococcus aureus).Bacteria), ESBLs E. coli, and CandidaMultiple high-threat drug-resistant bacteria and fungi, including Candida, exhibit strong and broad-spectrum lethal activity.

Its most groundbreaking advantage lies in its extremely high selectivity: while effectively eliminating pathogenic bacteria, it has no inhibitory activity on key probiotics (such as Lactobacillus crispatus) that maintain a healthy vaginal environment. This offers the potential to eradicate infections while protecting the crucial microecological balance, thereby reducing the risk of recurrence at its source.

In animal models of various typical vaginal infections, such as Gardnerella, MRSA, and Candida, iCAMP016 significantly reduced the vaginal pathogen load in a dose-dependent manner, showing efficacy superior to some existing positive control drugs.

In terms of safety, the drug shows extremely low systemic exposure after local administration, with no genotoxicity or significant irritation reactions. Its chemical synthesis process is well-established, demonstrating high stability and excellent clinical transformation potential.

Globally, drug-resistant bacterial infections have become a severe public health challenge. iCarbonX All, through its AI-driven antimicrobial peptide development platform, provides novel solutions for multidrug-resistant bacterial infections. iCAMP016, as a topical medication, combines three key advantages: broad-spectrum antibacterial activity, low propensity to induce resistance, and microbiome protection, showing potential as a breakthrough therapy in the field of bacterial vaginosis. It not only offers a promising new treatment option for clinical practice but also validates the capability of its "digital molecule" technology platform to produce globally competitive innovative drugs.

iCarbonX All stated that it will strictly adhere to national regulatory requirements, advancing the subsequent clinical trials of iCAMP016 with high quality, and continuously expand the application value of antimicrobial peptides in women's health and other infectious disease fields. It will accelerate the research and development progress of multiple innovative drug pipelines, committing to bring patients more precise and user-friendly next-generation treatment solutions.