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Global new Drug R&D express from FibroGen,Trellis Bioscience,Chiesi Global Rare Diseases...

1 FibroGen Announces Results for MATTERHORN, a Phase 3 Clinical Study of Roxadustat for the Treatment of Anemia in Patients with Myelodysplastic Syndromes (MDS)

FibroGen announced that MATTERHORN, a Phase 3 clinical study of roxadustat for the treatment of anemia in patients with transfusion-dependent lower-risk myelodysplastic syndromes (MDS) did not meet its primary efficacy endpoint. The proportion of patients who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for the roxadustat arm compared to 33.3% for placebo (p=0.217).

2 Trellis Bioscience Announces Positive Interim Phase 1 Results for TRL1068, a Novel Native Human Monoclonal Antibody Which Reduces Bacterial Biofilm Burden in Chronic Prosthetic Joint Infections

Trellis Bioscience announced a clinical proof-of-concept trial from a planned interim analysis of the company's Phase 1 trial of TRL1068 in patients with prosthetic joint infections. 75% of PJI patients (6/8) treated with a single dose of TRL1068 and standard antibiotics had a bacterial biofilm burden below 100 CFU/mL sonication fluid after only 7 days of treatment compared to historical data where only 15% of PJI patients. TRL1068 is well-tolerated across both dose groups with no drug-related adverse events.

3 Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease

Chiesi Global Rare Diseases announced that the European Commission (EC) has granted marketing authorization to PRX-102 (pegunigalsidase alfa) in the European Union (EU) for the treatment of adult patients with Fabry disease. PRX-102 is a PEGylated enzyme replacement therapy (ERT). It is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life.

4 Targeting RAS: Go lden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer

Golden Biotechnology announces the release of positive interim results from its Phase II clinical trial of Antroquinonol (HOCENA®) in combination with the standard of care (SOC) nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer. The median overall survival (mOS) was 12.6 months, which was 48% better than the 8.5 months mOS in the Phase III clinical study of the standard of care (nab-paclitaxel + gemcitabine). Compared to the current first-line treatments for this difficult to treat cancer, this study demonstrated that Antroquinonol in combination with SOC showed a significant survival advantage.

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