aTyr Pharma announced a collaboration and license agreement with Kyorin Pharmaceutical to develop and commercialize ATYR1923, its potential disease-modifying treatment for those with interstitial lung diseases (ILDs), including pulmonary sarcoidosis, in Japan.
ATYR1923 is a fusion protein that contains a portion of a human antibody linked to a protein called histidyl tRNA synthetase. It has been designed to suppress immune responses associated with lung inflammation and scarring (fibrosis) by modulating the activity of the neuropilin-2 (NRP-2) receptor protein.
“We are very pleased to enter into this collaboration with Kyorin, a leading respiratory focused pharmaceutical company in Japan,” Sanjay Shukla, MD, president and CEO of aTyr, said in a press release.
“As in the U.S., ILDs represent an area of significant unmet medical need in Japan, and Kyorin’s development and commercial capabilities will enhance our ability to improve the lives of patients with these serious conditions. We believe this collaboration further validates ATYR1923, and potentially accelerates development in other ILDs,” Shukla added.
The safety, tolerability, early efficacy, immunogenicity, and pharmacokinetic properties of ATYR1923 are currently being investigated in up to 36 people with pulmonary sarcoidosis in a Phase 1b/2a clinical trial (NCT03824392). (Immunogenicity is the ability a compound to trigger an immune response; and pharmacokinetics studies how a therapy affect the body: how it’s absorbed, distributed, metabolized, and eliminated.)
Patients will be randomly assigned to either ATYR1923 at a dose of 1.0, 3.0, or 5.0 mg/kg, or a placebo every four weeks. The main goal of the trial, which is recruiting at about a dozen sites across the U.S., is to assess the incidence of treatment side effects from the study’s start (baseline) until week 24.
A pre-planned interim analysis of the first 15 people treated in the trial indicated that ATYR1923 has a good safety profile, with only mild-to-moderate adverse events reported. Most were found to be unrelated to the treatment.
Under the terms of the agreement, Kyorin will hold the exclusive right to develop and commercialize ATYR1923 in Japan. The company will also be responsible for funding all research, development, regulatory, marketing, and commercialization activities related to ATYR1923 in the country.
In turn, aTyr will receive an upfront payment of $8 million, and be eligible for additional payments totaling up to $167 million once certain developmental, regulatory, and sales milestones are achieved. aTyr will supply all therapeutic products for Japan, and provide additional developmental support.
“We are excited to enter into this agreement with aTyr and bring this new, potentially first-in-class drug to Japanese ILD patients,” said Yutaka Ogihara, president and CEO of Kyorin Holdings, the parent company of Kyorin Pharmaceuticals.