AlphMol obtained IND approval from both Chinese CDE and American FDA
Release Time: 2025-06
From: AlphaMol

We are very pleased to announce that AlphMol obtained IND approval from both Chinese CDE and American FDA for the leading auto immune pipeline.

This drug candidate AM-001 is an oral small molecule, targeting MRGPRX2 receptor to treat different auto immune diseases including atopic dermatitis, urticaria and potentially others. AM-001 is a very safe drug candidate with the safety margin >600 folds in the GLP tox study in monkey. Its outstanding in vivo efficacies were verified by different animal models. Related clinical trial will be started soon.

About the target MRGPRX2

MRGPRX2 is a clinically proof-of-concepted G protein-coupled receptor which is on the surface of mast cell. It was distributed abandonly in the skin, adipose tissue as well as intestinal tract. The receptor is activated by a broad spectrum of ligands that are prevalent during inflammation. Targeting MRGPRX2 has great potential across an array of chronic inflammatory diseases and play a role in mitigating neurogenic inflammation. It would be a very attractive alternative to nowadays biologics treatment.

The role of MRGPRX2 in mast cell degranulation

About AlphaMol

AlphaMol is an innovative biotech combining computational biology, artificial intelligence and cutting-edged biotechnology to advance GPCR drug discovery. Both cofounders of AlphaMol Dr. Horst Vogel and Dr. Shuguang Yuan, who are in the list of“Top 2% Scientists”in the world, have worked in this area for a long time. AlphaMol has established a dedicated platform GPCR-Discovery specifically for GPCR drug development, including GPCR-GPT to find new target; GPCR-3D to predict GPCR structure; Alpha-screen to screen functional drug candidate; GPCRomx to predict ligand selectivity, GPCR-lead to perform lead optimization; and GPCR-XDC to design peptide-drug conjugates.  In 2022, the team of AlphaMol won the 4th global GPCR-DOCK contest. The model of opioid receptor-peptide prediction of AlphaMol was ranked as No. 1 in the world.

The GPCR-AI platform of AlphaMol

Thanks to this excellent platform, AlphaMol managed to complete several high-quality preclinical drug discovery within 6-12 months which is much faster than traditional ways. AlphaMol continues its innovations in GPCR drug discovery.