Drugs / pegunigalsidase alfa
pegunigalsidase alfa
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Fabry disease 5 milestones | |||||
| Filed | EU (EMA) | — | Fabry disease | 2024-12-09 | “today announced that the European Medicines Agency (EMA) has validated the Variation Submission for pegunigalsidase alfa” protalix.com ↗ “Most recently, the European Medicine Agency (EMA) validated Chiesi's Variation Submission for pegunigalsidase alfa” protalix.com ↗ “the European Medicines Agency (EMA) validated the Variation Submission for pegunigalsidase alfa” protalix.com ↗ |
| Filed | US (FDA) | — | Fabry disease | 2022-11-09 | “resubmitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with...” protalix.com ↗ |
| Filed | EU (EMA) | — | Fabry disease | 2022-02-24 | “24, 2022 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of...” protalix.com ↗ |
| Rejected (CRL) | US (FDA) | — | Fabry disease | 2021-04-27 | “receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of...” protalix.com ↗ |
| Filed | US (FDA) | — | Fabry disease | 2020-05-27 | “announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa” protalix.com ↗ “Submitted a Biologics License Application (BLA) to the FDA for PRX–102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease” protalix.com ↗ “submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa” protalix.com ↗ “announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa” protalix.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Elfabrio | — | 2023-05-04 | europa.eu ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01981720 | Jan 2014 → Aug 2020 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 1/2 | NCT01678898 | Oct 2012 → Mar 2016 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06328608 | Jul 2025 → Oct 2028 expected | Fabry disease | Chiesi Farmaceutici S.p.A. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05710692 | Aug 2023 → Oct 2027 expected | Fabry disease | Chiesi Farmaceutici S.p.A. | Recruiting | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT03614234 | Nov 2018 → Apr 2026 | Fabry disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT03566017 | Sep 2018 → Jan 2025 | Fabry disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT03180840 | Jul 2017 → Aug 2020 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 3 | NCT02921620 | Jul 2017 → Jul 2018 | Fabry disease | Protalix | Withdrawn | No outcome recorded |
| Phase 3 | NCT03018730 | May 2017 → Dec 2019 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 3 | NCT02795676 | Jun 2016 → Oct 2021 | Fabry disease | Protalix | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT04552691 | — | Fabry disease | Chiesi Farmaceutici S.p.A. | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 53
| Date | Issuer | Release |
|---|---|---|
| 2026-03-18 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Approval of Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) chiesi.com ↗
today announced that the European Commission (EC) has approved the 2mg/kg every-4-weeks (E4W) dosing regimen for pegunigalsidase alfa in adults living with Fabry disease who are stable with an ERT. |
| 2026-03-09 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Approval of Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) protalix.com ↗
European Commission approved dosing regimen reduces the burden for eligible patients, their families, and the broader healthcare system by extending infusion interval frequency from every-two-weeks to every-four-weeks for those stable with an enzyme replacement therapy (ERT) |
| 2026-01-30 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) in the EU chiesi.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks (E4W) dosing regimen for pegunigalsidase alfa in Fabry disease adult patients stable with an ERT treatment. |
| 2026-01-30 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) in the EU protalix.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks (E4W) dosing regimen for pegunigalsidase alfa in Fabry disease adult patients stable with an ERT treatment. |
| 2025-11-03 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU protalix.com ↗ |
| 2025-10-17 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU protalix.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion |
| 2024-12-09 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfa protalix.com ↗
today announced that the European Medicines Agency (EMA) has validated the Variation Submission for pegunigalsidase alfa ▼ to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. |
| 2023-05-10 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce FDA Approval of ELFABRIO® (pegunigalsidase alfa-iwxj) for the Treatment of Fabry Disease protalix.com ↗ |
| 2023-05-05 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease protalix.com ↗
today 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. |
| 2023-02-24 | Chiesi Farmaceutici S.p.A. | Results Chiesi Global Rare Diseases Presents Long-Term Results from Phase 3 BALANCE and BRIGHT Studies in Fabry Disease at the 19th Annual WORLDSymposium™ Research Meeting chiesi.com ↗ |
| 2023-02-24 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for Pegunigalsidase Alfa for Treatment of Fabry Disease chiesi.com ↗ |
| 2023-02-24 | Protalix | Regulatory Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for Pegunigalsidase Alfa for Treatment of Fabry Disease protalix.com ↗
Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company, announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX–102 (pegunigalsidase alfa), the first and only pegylated enzyme for the treatment of adult patients with Fabry disease. |
| 2022-12-05 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance of a Resubmitted Biologics License Application for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease protalix.com ↗
The FDA indicated in the BLA filing communication letter that the resubmitted BLA was considered a complete, class 2 response and set an action date of May 9, 2023, under the Prescription Drug User Fee Act (PDUFA). |
| 2022-11-14 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Resubmission of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease protalix.com ↗
The BLA resubmission includes a comprehensive set of clinical and manufacturing data. |
| 2022-04-04 | Protalix | Results Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Topline Results from the 24-Month Phase III BALANCE Clinical Trial of PRX-102 for the Treatment of Fabry Disease protalix.com ↗
today announced topline results from the BALANCE pivotal Phase III clinical trial evaluating pegunigalsidase alfa (PRX–102), 1 mg/kg, administered every two weeks, compared to agalsidase beta (Fabrazyme®) for the treatment of Fabry disease. |
| 2022-03-18 | Protalix | Results Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of the BRIGHT Phase III Clinical Trial Evaluating PRX-102 for the Treatment of Fabry Disease protalix.com ↗
The results indicate that treatment with 2 mg/kg of PRX-102 administered by intravenous (IV) infusion every four weeks was well tolerated, and Fabry disease assessed by estimated glomerular filtration rate (eGFR) slope and plasma lyso-Gb3 concentration was stable. |
| 2022-02-27 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease protalix.com ↗ |
| 2022-02-24 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease protalix.com ↗
today announced the submission of a Marketing Authorization Application (MAA) via centralized procedure to the European Medicines Agency (EMA) for pegunigalsidase alfa (PRX‑102) |
| 2021-10-11 | Protalix | Regulatory Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Regulatory Update on PRX-102 for the Treatment of Fabry Disease protalix.com ↗
We are pleased with the results of the Type A meeting, |
| 2021-06-02 | Protalix | Results Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Treatment of Fabry Disease protalix.com ↗
Companies Announce Topline Results from Interim Analysis of Phase III BALANCE Clinical Trial |
| 2021-04-28 | Protalix | Regulatory Protalix BioTherapeutics Provides Update on Complete Response Letter for Pegunigalsidase Alfa from the FDA protalix.com ↗
The CRL did not report any concerns relating to the potential safety or efficacy of PRX–102 in the submitted data package. |
| 2021-04-28 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA protalix.com ↗ |
| 2021-02-23 | Protalix | Results Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Positive Topline Results from BRIGHT Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa 2 mg/kg every Four Weeks for Treatment of Fabry Disease protalix.com ↗
today announced positive topline results from the BRIGHT Phase III clinical trial evaluating pegunigalsidase alfa (PRX–102), 2 mg/kg, administered every four weeks, for the potential treatment of Fabry disease. |
| 2021-02-10 | Protalix | Results Protalix BioTherapeutics and Chiesi Global Rare Diseases Present Key Clinical Data of Pegunigalsidase Alfa for the Treatment of Fabry Disease at the 17th Annual WORLDSymposium™ 2021 protalix.com ↗
The data to be presented by Prof. Linhart showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to pegunigalsidase alfa. |
| 2020-12-30 | Protalix | Results Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease protalix.com ↗
today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. |
| 2020-11-27 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease protalix.com ↗
The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021. |
| 2020-10-29 | Protalix | Regulatory Protalix BioTherapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update protalix.com ↗
Announced U.S. Food and Drug Administration (FDA) acceptance of the BLA submitted for PRX–102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease and grant of Priority Review designation to the BLA. |
| 2020-08-11 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance of Biologics License Application (BLA) for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease and Grants Priority Review protalix.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. |
| 2020-05-28 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Submission of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease protalix.com ↗ |
| 2020-05-11 | Protalix | Results Protalix BioTherapeutics Announces Positive Topline Results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease protalix.com ↗
Topline results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to PRX-102. |
| 2020-02-10 | Protalix | Results Protalix BioTherapeutics Presents Key Clinical Data of Pegunigalsidase Alfa for the Treatment of Fabry Disease at the 16th Annual WORLDSymposium™ 2020 protalix.com ↗
12-Months on-treatment Phase III BRIDGE study interim data analysis indicates significant improvement in kidney function in patients switched from agalsidase alfa (Replagal®) to pegunigalsidase alfa (PRX-102) |
| 2020-02-06 | Protalix | Regulatory Protalix BioTherapeutics and Chiesi Farmaceutici Announce Receipt of "Agreement Letter" for Initial Pediatric Study Plan for PRX-102 for the Treatment of Fabry Disease protalix.com ↗
today announced an agreement with the U.S. Food and Drug Administration (FDA) for the Initial Pediatric Study Plan (iPSP) for pegunigalsidase alpha, or PRX-102. |
| 2019-10-17 | Protalix | Results Protalix BioTherapeutics Announces Positive 12-Month Interim Data From the BRIDGE Phase III Open Label Switch-over Study of Pegunigalsidase Alfa for the Treatment of Fabry Disease protalix.com ↗
12-Months On-treatment Data Indicate Significant Improvement in Kidney Function in Patients Switched from agalsidase alfa (Replagal®) to pegunigalsidase alfa |
| 2019-02-05 | Protalix | Results Protalix BioTherapeutics Presents Preliminary Data from the BRIGHT Study of pegunigalsidase alfa for the Treatment of Fabry Disease at the 15th Annual WORLDSymposium™ 2019 protalix.com ↗
Additionally, pre-existing ADAs generated in patients prior to switching to PRX-102 had substantially little effect on the circulation of PRX-102 for the 4-week period evaluated, and PRX-102 concentration in circulation was higher than agalsidase beta, even in the presence of ADAs. |
| 2018-10-05 | Protalix | Results Protalix BioTherapeutics Presents Positive Preliminary Data from the BRIDGE Study of pegunigalsidase alfa for the Treatment of Fabry Disease at the 1st Canadian Symposium on Lysosomal Diseases 2018 protalix.com ↗
A deterioration trend in patients’ kidney function on agalsidase alfa (Replagal®) was reversed to an improvement trend when switched to pegunigalsidase alfa (PRX-102) |
| 2018-09-21 | Protalix | Results Protalix BioTherapeutics Reports Positive Preliminary Data from the BRIDGE Study of pegunigalsidase alfa for the Treatment of Fabry Disease protalix.com ↗
Preliminary data from the first sixteen patients enrolled in the trial demonstrated an improvement in kidney function when switched from agalsidase alfa (Replagal®) to pegunigalsidase alfa (PRX-102). |
| 2018-05-25 | Protalix | Results Protalix BioTherapeutics Announces Poster Presentation on Baseline Characteristics for Fabry Disease Patients Screened in the Phase III BALANCE Study of Pegunigalsidase Alfa at the 55th ERA-EDTA Congress protalix.com ↗
Remaining Effective Enzyme in Blood Samples was more than Double for Pegunigalsidase Alfa (PRX-102) Compared to Fabrazyme® as a Result of Higher Inhibition of Neutralizing Antibodies Measured in Fabrazyme |
| 2018-01-31 | Protalix | Regulatory Protalix BioTherapeutics’ pegunigalsidase alfa Receives Fast Track Designation from the U.S. Food and Drug Administration protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pegunigalsidase alfa, or PRX-102, the Company’s plant cell-expressed recombinant, pegylated, cross-linked α-galactosidase-A candidate for the treatment of Fabry disease. |
| 2017-12-27 | Protalix | Regulatory Protalix BioTherapeutics’ PRX-102 Granted Orphan Drug Designation by the European Commission protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®, announced today that the European Commission granted Orphan Drug Designation (ODD) for pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease. |
| 2017-11-27 | Protalix | Results Protalix BioTherapeutics Presents Positive Results from the Phase I/II Open-Label Extension Trial for PRX-102 at the New Horizons for Fabry Disease Conference protalix.com ↗
The long-term results at 24 months indicate that PRX-102 continues to demonstrate a remarkable improvement and stability across all key Fabry disease parameters. |
| 2017-11-13 | Protalix | Regulatory Protalix BioTherapeutics Receives Positive Opinion for Orphan Designation for PRX-102 for the Treatment of Fabry Disease in the European Union protalix.com ↗
In its official opinion letter, the COMP explained that Protalix has established that although satisfactory methods of treatment of Fabry disease have been authorized in the European Union, PRX-102 will be of significant benefit to those affected by Fabry disease. |
| 2017-05-09 | Protalix | Regulatory Protalix Announces FDA Investigational New Drug Clearance to Commence Once-Monthly Dosing Study of pegunigalsidase alfa (PRX-102) for the Treatment of Fabry Disease protalix.com ↗ |
| 2017-04-18 | Protalix | Results Protalix BioTherapeutics Announces New Preclinical Results Demonstrating a Positive Effect of pegunigalsidase alfa (PRX-102) on Small-fiber Neuropathy in Fabry Disease Models Compared to Commercially Available Enzyme Replacement Therapies protalix.com ↗
It was demonstrated that treatment of Fabry mice with pegunigalsidase alfa (PRX-102) slows the progression of small fiber neuropathy when compared to treatment of Fabry mice with currently approved enzyme replacement therapies, and when compared to untreated Fabry mice. |
| 2016-09-07 | Protalix | Results Protalix BioTherapeutics Announces Presentation of Results from the Phase I/II Clinical Trial of PRX-102 for the Treatment of Fabry Disease at the Society for the Study of Inborn Errors of Metabolism protalix.com ↗
The clinical results indicate that PRX-102 demonstrated improvements or stabilization across all disease parameters including, plasma Lyso-Gb3, kidney function, cardiac function and pain. |
| 2016-08-10 | Protalix | Results Protalix BioTherapeutics Announces Additional Positive Data from its Phase I/II Clinical Trial for PRX-102 for the Treatment of Fabry Disease protalix.com ↗
The efficacy results seen to date continue to be very strong with improvements or stabilization in efficacy demonstrated across all disease parameters giving us confidence in our phase III head-to-head study comparing PRX-102 versus Fabrazyme®. |
| 2016-03-03 | Protalix | Results Protalix BioTherapeutics Presents Positive Six and Twelve Month Interim Clinical Data on PRX-102 for the Treatment of Fabry Disease at the 12th Annual WORLDSymposium™ 2016 protalix.com ↗ |
| 2015-11-16 | Protalix | Regulatory Protalix BioTherapeutics to Conduct Phase III Clinical Trial for PRX-102 for the Treatment of Fabry Disease Following a Successful End-of-Phase II Meeting With FDA protalix.com ↗
Official FDA meeting minutes indicate the FDA's acceptance of the Company's path forward for a phase III clinical trial to support a full BLA approval. |
| 2015-10-19 | Protalix | Results Protalix BioTherapeutics Reports Positive Long Term Data on PRX-102 for Fabry Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today positive long term data from the 0.2mg, or lowest dose, of the Company's phase I/II dose ranging clinical trial of PRX-102 for the treatment of Fabry disease. |
| 2015-09-09 | Protalix | Results Protalix BioTherapeutics Reports Positive Phase I/II Interim Clinical Data on the 1mg/kg Cohort of PRX-102 for Fabry Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today positive interim data from the Company's phase I/II clinical trial of 1mg/kg of PRX-102 for the treatment of Fabry disease. |
| 2015-02-12 | Protalix | Results Protalix BioTherapeutics Presents Additional Positive Phase I/II Interim Clinical Data on PRX-102 for Fabry Disease at the WORLD Symposium protalix.com ↗
It is very impressive to see stability data with favorable trends in cardiac and renal disease parameters after only six months of treatment. |
| 2015-01-08 | Protalix | Results Protalix BioTherapeutics Reports Positive Interim Data From Phase I/II Clinical Trial of PRX-102 for the Treatment of Fabry Disease protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today positive interim efficacy and safety data from the Company's ongoing phase I/II clinical trial of PRX-102 for the treatment of Fabry disease. |
| 2012-08-13 | Protalix | Regulatory Protalix BioTherapeutics Receives FDA IND Clearance to Initiate a Phase I/II Study of Fabry Disease Patients With PRX-102, a Modified Enzyme Replacement Therapy protalix.com ↗ |
| 2011-01-19 | Protalix | Results Protalix BioTherapeutics Presents Data on the Company's Fabry Program and Oral Enzyme Gaucher Program With Experts in the Field of Lysosomal Disorders protalix.com ↗
In pre-clinical studies, PRX-102 demonstrated preliminary efficacy in a Fabry animal model. |
All press releases naming this drug 72 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pegunigalsidase alfa | “A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Pegunigalsidase Alfa (PRX-102) in Japanese Patients With Fabry Disease (RISE)” NCT05710692 ↗6“This study aims to learn how safe pegunigalsidase alfa (PRX-102 for short) is and how it works at treating Fabry disease in children and adolescents.” NCT06328608 ↗ |
| Known as | Elfabrio | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297801 ↗ |
| Known as | Pegunigalsidasa alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297801 ↗ |
| Known as | Pegunigalsidase alfa-iwxj | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297801 ↗ |
| Known as | PRX-102 | “pegunigalsidase alfa (PRX-102) is a drug made using genetic engineering techniques and manufactured using cultured tobacco cells.” NCT05710692 ↗6“This is an open label switch over study to assess the safety and efficacy of PRX-102 (pegunigalsidase alfa).” NCT03018730 ↗ |
| Action | Restore | “developed as enzyme replacement therapy (ERT) for Fabry disease (FD)” PMID 30834538 ↗ Apr 2019 |
| Modality | Protein / enzyme biologic | “PRX-102, an enzyme being developed as a long-term enzyme replacement therapy” NCT01678898 ↗ |
| Route | Intravenous | “receive PRX-102 as an intravenous infusion every 2 weeks for 12 weeks (3 months)” NCT01678898 ↗ |