Company: GIFLF
Filing Date: 2025-07-30
Form Type: 6-K
Source: 0001104659-25-071915
Chunk: 9

Company: Grifols SA
Filing Date: 2025-07-30
Form: 6-K
Chunk 9
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. planned for the first part of 2026.                                       
 Pioneering high-tech analysis of plasma bank to detect early signs of Parkinson’s disease                                      
 In January, Grifols received a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to identify            
 plasma-based biomarkers that could indicate a person’s likelihood of developing Parkinson’s disease (PD) many years            
 before clinical diagnosis. The initiative, called “Chronos-PD,” could accelerate the discovery of new diagnostic tools as well 
 as the identification and development of novel disease-modifying therapeutics. The $21 million award will fund a pilot         
 study to analyze longitudinal plasma samples covering a period of up to 10 years. This will enable researchers to track how    
 distinct plasma proteins evolve over time in people with PD, which could help establish an early-warning system for the        
 emergence of the disease.                                                                                                      
 Completion of enrollment of second cohort in first-in-human Alpha-1 15% subcutaneous option for treating alpha1-               
 antitrypsin deficiency                                                                                                         
 In February, Grifols finished recruiting the second cohort of its Phase 1/2 study (NCT04722887) evaluating the safety and      
 tolerability of two different doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% (Alpha-1 15%) as a                 
 subcutaneous (SC) option for the treatment of alpha1-antitrypsin (AAT) deficiency, compared to Liquid Alpha1-Proteinase        
 Inhibitor (Human) intravenous (IV).                                                                                            
 A clearance of IND application for Phase 2 trial of immunoglobulin drops for dry eye disease                                   
 In May, the United States Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND)              
 application to initiate a Phase 2 trial evaluating its immunoglobulin (IG) drops – GRF312 Ophthalmic Solution – for what       
 could become the first-ever ocular surface indication for an IG and a potential new treatment for dry eye disease (DED).       
 Positive fibrinogen phase 3 trial results published in The Lancet’s eClinicalMedicine                                          
 In June, Grifols announced that the positive Phase 3 study data on its fibrinogen concentrate, BT524, has been published in    
 eClinicalMedicine, a peer-reviewed journal published by The Lancet Discovery Science Suite. The article highlights that        
 the trial met its primary endpoint, demonstrating