Pandemic Likely to Delay Results of Trial into Pulmonary Sarcoidosis Treatment
Results of a Phase 1b/2a clinical study evaluating ATYR1923 in people with pulmonary sarcoidosis are likely to be delayed due to the COVID-19 pandemic, its developer, aTyr Pharma, announced.
ATYR1923 is a first-in-class therapy being developed to possibly different types of interstitial lung diseases (ILDs) — a group of disorders, including pulmonary sarcoidosis, characterized by scarring in the lungs and poorer lung function.
This investigational therapy works by altering the activity of the protein neuropilin-2 (NRP-2), which plays a role in limiting inflammatory responses, including lung inflammation and associated scarring/damage.
An ongoing Phase 1b/2a clinical trial (NCT03824392) is evaluating ascending doses of ATYR1923 in up to 36 people with pulmonary sarcoidosis. It is intended to determine the safety and tolerability of ATYR1923 at six months of use, as well as its immunogenicity (ability to trigger an immune response) and pharmacokinetics (how the therapy moves through, and is processed by, the body). Early efficacy will also be assessed.
This trial may still be interested in patients thinking of enrolling at sites across the U.S.; contact and other information is available here.
A pre-planned interim (mid-study) analysis from the first 15 trial participants suggested that the therapy is generally safe and well-tolerated; no serious adverse events related to ATYR1923 were reported. These findings are in line with previous data from a Phase 1 study (ACTRN12617001446358) conducted in healthy volunteers.
Full trial results were expected to be released by September, but aTyr announced that these data will likely be delayed.
“As the COVID-19 pandemic continues to impact daily life, we remain committed to the safety of our employees as well as our physician partners and the patients who are participating in our ATYR1923 Phase 1b/2a clinical study,” Sanjay S. Shukla, president and CEO of aTyr, said in a company’s press release.
“This global public health crisis has been challenging for clinical trial conduct worldwide, and we now anticipate there will be a delay in topline results from our study, which were previously anticipated in the third quarter of this year,” Shukla added. We are working closely with our investigators to implement procedures which will allow for rapid completion of this study when the demand on the health system eases.”
aTyr joined with the nonprofit Foundation for Sarcoidosis Research (FSR) in developing and sponsoring trial.
The company also reviewed last year’s accomplishments it its release, including entering into a license agreement with Kyorin Pharmaceutical to develop ATYR1923 in Japan. The agreement was recently finalized.
“We remain committed to completion of our Phase 1b/2a study as expeditiously as possible as we work to introduce an entirely new class of therapeutics to treat unmet needs in interstitial lung diseases,” Shukla said.