CSP strikes $336M deal to market Daewoong’s IPF therapy in China
Data from a Phase 2 US trial on bersiporocin are expected by mid-2024
CS Pharmaceuticals (CSP) has entered into an exclusive in-licensing agreement with Daewoong Pharmaceutical to develop and commercialize bersiporocin, an oral experimental anti-fibrotic medication for idiopathic pulmonary fibrosis (IPF) and other respiratory diseases in the greater China region.
“This will be the stepping stone towards becoming a game changer in the global development of bersiporocin for IPF and other life-threatening diseases,” Seng-ho Jeon, CEO of Daewoong Pharmaceutical, said in a press release.
Under the terms of the agreement, CSP will acquire exclusive rights to develop and commercialize bersiporocin in the greater China region, which includes mainland China, as well as Hong Kong, Taiwan, and Macau. In the deal, worth up to $336 million, Daewoong Pharmaceutical will be eligible to receive up to $76 million in upfront and development milestone payments, plus double-digit royalties on net sales.
Bersiporocin designed to block protein involved in collagen production
“Securing the Chinese commercial rights to Bersiporocin with the initial focus in IPF marks another milestone for CSP, as we continue to expand our portfolio of innovative products in China. IPF is a priority rare disease in China [with] a huge unmet need,” said Darren Mercer, CSP’s CEO.
“Completing this transaction further strengthens our rare disease portfolio as we continue to focus on bringing innovative rare disease and ophthalmology medicines to Chinese patients, to address the significant unmet medical needs in this rapidly growing market,” Mercer said.
Bersiporocin, formerly known as DWN12088, is designed to block the activity of a protein called Prolyl-tRNA Synthetase, which is involved in the production of collagen — a structural protein and a key component of scar tissue.
Fibrotic diseases like IPF are characterized by an overproduction of collagen. By lowering collagen production, bersiporocin is expected to reduce lung scarring (fibrosis).
A Phase 1 clinical trial conducted in Australia showed bersiporocin was generally well-tolerated and able to reduce collagen production as intended, in a group of healthy volunteers.
In June 2022, the U.S. Food and Drug Administration (FDA) gave clearance for Daewoong to launch a Phase 2 trial (NCT05389215) testing the therapy in IPF patients.
Phase 2 study to test efficacy of bersiporocin to improve pulmonary function
The study seeks to enroll up to 102 IPF patients, 40 or older, who will be randomly assigned to receive a tablet of bersiporocin or a placebo, twice daily, for 24 weeks (about half a year).
Its main aim is to assess the efficacy of bersiporocin to improve pulmonary function, which will be assessed by analyzing the rate of decline in forced vital capacity — a lung function parameter that measures the total amount of air a person can exhale after a deep breath. Treatment safety will also be evaluated as a primary goal.
Additional (secondary) goals include assessing the effects of bersiporocin on IPF progression.
Data from the study is expected by mid-2024.
Bersiporocin was granted an orphan drug designation by the FDA in 2019, and a fast track designation in 2022. Both designations are given to therapies that are intended to treat serious conditions and fill an unmet medical need. They are awarded to speed development and regulatory review of potential treatments.
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