Kyorin Pharmaceutical is paying $12 million upfront for the Japan rights to Edesa Biotech’s late-stage anti-TLR4 antibody to treat acute respiratory distress syndrome (ARDS).
Edesa has been scouting out potential partners for the drug, called paridiprubart, as the Canadian biotech assesses ways to take the drug into major markets around the world. It’s now found a solution in Japan, where Kyorin has pledged up to $134 million in potential milestones, as well as a slice of the royalties.
Under the deal, Kyorin will bankroll the development, regulatory and commercialization activities in Japan for paridiprubart as a treatment for ARDS, and has the right of first negotiation to develop the drug for acute kidney injury (AKI) in the country along with an option to bid for the rights in other potential indications.
A 100-person phase 3 study a year ago linked the antibody to improvements in survival and recovery of patients with ARDS caused by COVID-19. However, Edesa halted the trial and shifted its focus for the drug to general ARDS rather than cases caused by COVID-19 after the Biomedical Advanced Research and Development Authority (BARDA) selected paridiprubart for inclusion in a platform trial of potential ARDS treatments last year.
Since then, Edesa has been conducting additional exploratory analyses to assess paridiprubart’s effect in ARDS patients who also have AKI. The biotech disclosed in the summer that, among this population, the company has seen the drug “associated with significant mortality reductions supported by concordant improvements in the kidney-specific MAKE30 composite endpoint.”
“We believe Kyorin’s experience with respiratory treatments and their extensive footprint in Japan make them a strong partner for the continued development and commercialization of paridiprubart, our potential first-in-class antibody,” Edesa CEO Par Nijhawan, M.D., said in the release.
In Japan, Kyorin already markets the chronic cough med Lyfnua and the Flutiform asthma inhaler.
“We are pleased, as a company with a strong foundation in respiratory medicine, to secure the exclusive rights to develop and commercialize EB05 in Japan, an innovative therapeutic candidate for ARDS—an extremely severe condition that requires intensive care,” Kyroin CEO Yutaka Ogihara said in the release.
“Conquering ARDS represents one of the most formidable frontiers in drug discovery, but that is precisely why it is profoundly meaningful for Kyorin to proactively take on this challenge,” Ogihara added.