{"id":783025,"date":"2023-09-11T09:21:10","date_gmt":"2023-09-11T13:21:10","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/atyr-pharma-presents-efzofitimod-data-demonstrating-statistically-significant-improvements-in-time-to-relapse-fvc-and-patient-reported-outcomes\/"},"modified":"2023-09-11T09:21:10","modified_gmt":"2023-09-11T13:21:10","slug":"atyr-pharma-presents-efzofitimod-data-demonstrating-statistically-significant-improvements-in-time-to-relapse-fvc-and-patient-reported-outcomes","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/atyr-pharma-presents-efzofitimod-data-demonstrating-statistically-significant-improvements-in-time-to-relapse-fvc-and-patient-reported-outcomes\/","title":{"rendered":"aTyr Pharma Presents Efzofitimod Data Demonstrating Statistically Significant Improvements in Time to Relapse, FVC and Patient Reported Outcomes"},"content":{"rendered":"
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\n Post-hoc analysis from Phase 1b\/2a study in pulmonary sarcoidosis presented at the European Respiratory Society (ERS) International Congress 2023.<\/em>
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\n 7.7% of patients in the 3.0 and 5.0 mg\/kg efzofitimod group relapsed following steroid taper, compared to 54.4% in the placebo and efzofitimod 1.0 mg\/kg group (p=0.017).<\/em>\n <\/p>\n

\n Rate of change for forced vital capacity (FVC) was significantly improved for the 3.0 and 5.0 mg\/kg efzofitimod group compared to placebo and the efzofitimod 1.0 mg\/kg group (p=0.035).<\/em>\n <\/p>\n

SAN DIEGO, Sept. 11, 2023 (GLOBE NEWSWIRE) — aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the results of a post-hoc analysis of data from its Phase 1b\/2a study of efzofitimod in patients with pulmonary sarcoidosis. The analysis was presented in a poster at the European Respiratory Society (ERS) International Congress 2023, which is taking place September 9 \u2013 13, 2023, in Milan, Italy. The poster is available on the Company\u2019s website.<\/p>\n

\u201cThis new data from a post-hoc analysis, which pools efzofitimod 3.0 and 5.0 mg\/kg and placebo and efzofitimod 1.0 mg\/kg doses from the Phase 1b\/2a study of efzofitimod in patients with pulmonary sarcoidosis, is yet another indicator of the robust efficacy demonstrated in this study,\u201d said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. \u201cThe statistically significant difference in the relapse rate following steroid taper seen in the two highest efzofitimod dose groups, combined with significantly improved FVC and quality of life measures, suggests that efzofitimod has the potential to be the first steroid-sparing and disease-modifying treatment for sarcoidosis.\u201d<\/p>\n

\u201cOral corticosteroids remain the mainstay of treatment for patients with pulmonary sarcoidosis, although long-term treatment often comes with severe side effects and toxicity. Steroid tapers in these patients are challenging, as symptoms and FVC can worsen when steroid dose is reduced,\u201d said Robert P. Baughman, M.D., Professor of Medicine at the University of Cincinnati Medical Center. \u201cThis analysis demonstrating a relapse rate limited to 7.7% for the efzofitimod therapeutic group is exciting, as we would normally expect to see a relapse rate as high as approximately 50% over the course of 6 months, which is what was observed in the subtherapeutic group, and the difference may even be more evident in a longer study. This is one of the few studies to demonstrate a steroid sparing effect of a drug associated with a significant improvement in patient outcome. A treatment such as efzofitimod that can reduce steroid burden is greatly needed.\u201d<\/p>\n

\n Therapeutic Doses of Efzofitimod Significantly Improve Multiple Pulmonary Sarcoidosis Efficacy Measures<\/strong>\n <\/p>\n

The poster presents findings from a pooled, post-hoc analysis of data from a Phase 1b\/2a randomized, double-blind, placebo-controlled, multiple ascending dose (1.0, 3.0 and 5.0 mg\/kg) 24-week study of efzofitimod in patients with pulmonary sarcoidosis receiving oral corticosteroid (OCS) dose \u2265 10.0 mg\/day. Patients were randomized 1:2 (placebo:efzofitimod) and underwent a forced steroid taper in the first 8 weeks of the study. Dose dependent improvements in steroid burden, FVC and patient reported outcomes (PRO) were noted, though the study was not powered for efficacy.<\/p>\n

In this pooled analysis, the 3.0 mg\/kg (N=8) and 5.0 mg\/kg (N=9) efzofitimod arms were considered therapeutic, and pooled. The placebo (N=12) and 1.0 mg\/kg (N=8) efzofitimod arm, which was considered subtherapeutic, were pooled. Time to relapse for steroid use (defined as dose of OCS increased after OCS taper to 5.0 mg or less of prednisone or equivalent for at least five consecutive days), rate of change for FVC and proportion of patients with changes that are multiples of the minimally clinically important difference (MCID) in PRO (Kings Sarcoidosis Questionnaire-Lung, or KSQ-L) were compared. Additionally, a responder endpoint was proposed (defined as reduction in OCS from baseline without worsening in FVC or PRO) and an analysis was performed. Key findings include:<\/p>\n