Item 8.01 Other Events.
On
The study demonstrated a preliminary signal of activity through clinical improvement in the high dose cohort with the assessment of time to recovery, defined as either achieving a WHO ordinal scale score of ?3 or hospital discharge with no requirement of supplemental oxygen. Patients who received the 3.0 mg/kg dose of ATYR1923 experienced a median time to recovery of 5.5 days compared to 6 days in the placebo group. In addition, 83% of patients receiving the high dose of ATYR1923 achieved recovery by day 6, compared to 56% in the placebo arm. Patients in the 1.0 mg/kg treatment arm experienced a median time to recovery of 7 days. All patients in the study received standard of care treatment at the time of enrollment, which included remdesivir and/or dexamethasone.
Adverse events were mostly mild or moderate in severity and generally assessed as unrelated to the study drug. This is in line with previous safety assessments of ATYR1923, including an interim safety analysis from an ongoing Phase 1b/2a trial in patients with pulmonary sarcoidosis, a chronic form of interstitial lung disease. There were two deaths observed in the study, both in the 1.0 mg/kg treatment arm, which were deemed not related to ATYR1923 by an independent data safety monitoring board.
The Phase 2 clinical trial was a randomized, double blind, placebo-controlled
study of ATYR1923 in 32 hospitalized COVID-19 patients with severe respiratory
complications, who did not require mechanical ventilation, at hospitals in the
Following the topline results, the Company will be reviewing the full data set from the study, which will include clinical biomarker data and 60 day follow up. The clinical biomarker data collected during the study, when patients' lungs are inflamed, may provide additional insight into the COVID-19 disease pathology and the effects of 1923 on key inflammatory cytokines. Of note, the vast majority of patients in the trial received concomitant dexamethasone as part of standard of care. The overwhelming use of dexamethasone in the study may also impact the biomarker analysis.
The Company believes that even with the availability of vaccines and the current standard of care, additional treatments will be needed for patients who develop severe disease and require hospitalization. The Company will continue to assess the opportunity and need for effective therapies, and assess the evolving standard of care, including additional data expected on the use of dexamethasone, and continue to monitor the status of vaccine administration. The Company has observed in other trials where background Dexamethasone has been used as standard of care-patients tended to recover in 7-10 days. This data continues to rapidly evolve and the severity of those patients does vary. The Company will be reviewing not only the additional insights from the full data set but also monitoring the evolving standard of care treatment landscape for COVID-19 patients in the near term to best inform the Company's next step planning.
A press release announcing the topline results is attached as Exhibit 99.1 hereto.
2 --------------------------------------------------------------------------------
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press Release ofaTyr Pharma, Inc. datedJanuary 4, 2021 3
--------------------------------------------------------------------------------
© Edgar Online, source