Highlights

1.Clear MoA. As an antagonist upstream of the TGF-β signaling pathway, HTPEP-001 mediates TGF-β1 activation by completely inhibiting the binding of TSP-1 and CD36, reducing multiple profibrotic factors expression.

2.Treat fibrosis sequelae of COVID-19. A systematic review and meta-analysis shows approximately 20% of COVID-19 patients, at least 48 million people, have evidence of fibrotic sequelae persisting at 1-year follow-up. As a pan-anti-fibrotic drug, the asset is a good therapeutic option for the sequelae.

3.Compared with Nintedanib by head-to-head assay in vivo, the asset displays better therapeutical efficacy for lung fibrosis.

4.Shows significant safety advantages over existing and developing treatment options.

5.Wide range of indications. At first, the asset is an effective therapeutic method for fibrosis diseases, especially lung fibrosis. Besides, the studies in vivo show the asset combined with anti-PD-1 mAb enhances the anti-tumor efficacy. (43% higher than anti-PD-1)

6.Great market prospect. There is huge unmet clinical needs in the field of fibrotic diseases, and the asset meets the needs with a great market prospect.

7.Dosage form variety. The asset is available for both intravenous and inhalation routes of administration, to meet the needs of different stage of PF-ILD patients.

Project progress

1.The pre-clinical pharmacodynamics study has been completed. Compared with nintedanib in rats induced fibrosis by bleomycin, displays obvious better therapeutic effect for IPF than Nintedanib.

2.The pre-clinical study in rats, beagles and cynomolgus monkey have been completed. They show no obvious adverse effects, and the asset possessing the margin of safety about 100 folds that is significantly better than nintedanib.

3.Manufacturing of the asset is a stable and highly qualified process, formulations of both inhalation and infusion solutions are well characterized and controlled