Prometic to Advance IPF and Other Anti-fibrotic Therapies in Clinical Testing via Partnership in China

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by Kevin Perez |

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Prometic recently announced a financial agreement and partnership with Shenzhen Royal Asset Management (SRAM) to develop, manufacture, and commercialize several of its anti-fibrotic products in China, including PBI-4050 for idiopathic pulmonary fibrosis (IPF).

PBI-4050 is an anti-fibrotic oral drug, which has demonstrated positive results in a Phase 2 study (NCT02538536) in 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. It was also shown to have a good safety and tolerability profile.

“We are also very pleased that our phase 2 open-label study in IPF patients has served the very important strategic purpose of allowing us to optimize the design of our pivotal clinical program” Pierre Laurin, president and CEO of Prometic, said in a press release.

The deal will provide Prometic with an initial $33 million to be used to advance in clinical testing candidates PBI-4050, PBI-4547 and PBI-4425, under development for conditions associated with pulmonary and liver fibrosis.

“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,” Yu Huang, founder and chairman of SRAM, said in a press release.

Prometic is now planning to start Phase 2/3 trials with PBI-4050 in IPF patients in 2017. These new trials will assess PBI-4050 in combination with Ofev compared to placebo, and PBI-4050 alone (monotherapy) in patients unable to tolerate Ofev or Esbriet (pirfenidone) —another approved IPF therapy.

PBI-4050 was designated an orphan drug by the U.S. Food and Drug Administration (FDA) in February 2015. The same designation was granted by the European Commission in October 2015.

“Beyond its financial contribution, SRAM will provide Prometic with the required local clinical, regulatory and operational expertise to efficiently execute in and capitalize upon the rapidly expanding Chinese market. The joint venture leverages Prometic’s R&D and clinical expertise and leadership, especially in the areas of fibrosis and autoimmune diseases/inflammation,” Laurin said.

PBI-4050 is also currently being tested as a therapy in Alström syndrome, chronic kidney disease, and metabolic syndrome associated with type 2 diabetes.

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