aTyr Pharma, which developing therapies to modulate immune pathways involved in lung diseases, has announced an upcoming Phase 1b/2a study to test their lead therapy ATYR1923 in patients with pulmonary sarcoidosis.
ATYR1923 is an immunomodulatory molecule that’s able to bind to the Neuropilin-2 (NRP-2) receptor protein, part of the Resokine pathway. Specifically, ATYR1923 was designed to enhance the Resokine pathway, a regulatory pathway of immune responses, with a focus on those affecting the lungs.
In a previous Phase 1 clinical trial (ACTRN12617001446358), researchers evaluated the safety and tolerability of single ascending doses of ATYR1923, administered intravenously (doses of ATYR1923 ranged from 0.03 mg/kg up to 5.0 mg/kg) in 36 healthy volunteers.
Researchers also assessed the therapy’s effects in immune pathways and its processing inside the body (pharmacokinetics).
After an eligibility/screening period of up to three weeks, participants underwent treatment with a single dose of ATYR1923 or placebo, and were assessed after four weeks.
Results showed that the investigative therapy was generally well-tolerated at all dose levels tested, with no significant adverse events. Researchers detected no antibodies following dosing or throughout the one-month follow-up period.
The therapy’s pharmacokinetics profile indicated that higher ATYR1923 doses led to more elevated concentrations of the therapy in the blood at the end of the one-month follow-up period. The levels were above the predicted therapeutic threshold, supporting the once-monthly dosing administration as a potential regimen.
“Last quarter, we announced top-line results from our ATYR1923 Phase 1 study in healthy human volunteers,” Sanjay Shukla, MD, president and CEO of aTyr Pharma, said in a press release.
“As previously indicated, we have used this data, along with recent translational research results and discussions with key opinion leaders, to guide our development plans for ATYR1923,” he said.
Shukla and Daniel Culver, MD, president-elect of the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) and chair of the Scientific Advisory Board for the Foundation for Sarcoidosis Research, will host a webinar to discuss the challenges of pulmonary sarcoidosis and introduce the ATYR1923 Phase 1b/2a clinical study design.
The webinar will be broadcast from San Antonio, Texas, during the CHEST Annual Meeting 2018, at 8 a.m. Eastern Time on Monday, Oct. 8.
“We are pleased to announce pulmonary sarcoidosis as the indication for our next study,” Shukla said. “Dr. Culver is a leading expert in the field and we appreciate his participation in our upcoming educational webinar to provide an overview of pulmonary sarcoidosis and the unmet medical need,” he added.