Canada’s Prometic Life Sciences and Shenzhen Royal Asset Management (SRAM) will jointly manufacture, develop and commercialize three fibrosis and scleroderma therapies in China, the two companies announced. namely the drugs PBI-4050, PBI-4547 and PBI-4425.
A new subsidiary, Prometic ChinaCo, will focus on the oral anti-fibrotic drugs PBI-4050 and PBI-4547. Prometic will also license sales and development rights to a SRAM affiliate for fibrosis products relevant to the Chinese market.
Fibrosis is part of an inflammatory response in which organs lose their function as healthy tissues get replaced by fiber-rich scar tissue.
PBI-4050 demonstrated excellent efficacy and safety in a Phase 2 clinical trial (NCT02538536) in U.S. patients with idiopathic pulmonary fibrosis (IPF). The treatment, either alone or in combination with Ofev (nintedanib), was found to slow lung function decline or stabilize patients’ respiratory function after 12 weeks of treatment.
The drug will enter Phase 2/3 clinical trials this year with IPF and chronic kidney disease (CKD) patients. CKD is the result of chronic damage to the kidneys — usually due to long term-diabetes — in which kidney tissues are gradually replaced with scar tissue, causing the organ to lose its function.
Under agreement, SRAM will initially pay Prometic $33 million. SRAM has also acquired a local Chinese pharmaceutical company to act as its commercial and development platform.
“We are very excited about the potential of the products being developed under this joint project and have already acquired a China-based pharmaceutical company to serve as the development and commercial platform, initially for PBI-4050 in diabetic kidney disease,” Yu Huang, founder and chairman of SRAM, said in a press release. Citing a recent study in The New England Journal of Medicine, he said China is home to about 114 million diabetics; an estimated 24 million of them also have CKD.
The molecule PBI-4425 is similar in action to PBI-4050. Clinical trials on the drug, which has shown significant benefits in pulmonary emphysema, are planned for late this year. PBI-4425 has also been effective in treating skin thickening in mice models of scleroderma — an autoimmune disease characterized by scarring of the skin and sometimes organs.
“The joint venture leverages Prometic’s R&D and clinical expertise and leadership, especially in the areas of fibrosis and autoimmune diseases/inflammation,” said Prometic President and CEO Pierre Laurin. “The joint venture is also actively pursuing additional partnering transactions to further leverage the value of its products in targeted indications in China and provide additional funding.”