Drugs / Coversin
last change Aug 2024 re-read 3 minutes ago

Coversin

also known as Nomacopan · rVA576

Protein / enzyme biologic targets C5 via inhibition

Developed for
paroxysmal nocturnal hemoglobinuria · thrombotic microangiopathy · bullous pemphigoid
Investigated by
AKARI Therapeutics · Radboud University Medical Center

Trials 3

201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials · 1 met primary
Phase 2 NCT03427060 May → Nov 2018 paroxysmal nocturnal hemoglobinuria AKARI Therapeutics Completed No outcome recorded
Phase 2 NCT02591862 Feb 2016 → Mar 2018 paroxysmal nocturnal hemoglobinuria AKARI Therapeutics Completed Met primary
Phase 31 trial
Phase 3 NCT04784455 Feb 2021 → May 2024 thrombotic microangiopathy AKARI Therapeutics Terminated No outcome recorded Stop: Business
Comparator or background therapy1 trial
Phase 3 NCT05061771 Comparator May → Aug 2022 bullous pemphigoid AKARI Therapeutics Withdrawn No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 56

DateIssuerRelease
2023-11-16 AKARI Therapeutics Results Akari Therapeutics Presents Poster on Progress in Pre-Clinical Development of Long-Acting PAS-Nomacopan as a Potential Treatment for Geographic Atrophy at the 4th Annual Dry AMD Therapeutic Development Conference akaritx.com ↗
Part of this progress is the advancement of a high yield manufacturing process that supports our program moving into clinical trials in 2024.
2023-07-27 AKARI Therapeutics Regulatory Akari Therapeutics Granted Nomacopan Orphan Drug Designation from the European Commission for Treatment in Hematopoietic Stem Cell Transplantation akaritx.com ↗
Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that the European Commission granted orphan drug designation to nomacopan as a treatment in hematopoietic stem cell transplantation following the European Medicines Agency positive opinion in June.
2023-07-06 AKARI Therapeutics Regulatory Akari Therapeutics Receives Positive Opinion on Orphan Drug Designation fromthe European Medicines Agency for Nomacopan for Treatment in HematopoieticStem Cell Transplantation akaritx.com ↗
Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the company’s application for orphan drug designation for nomacopan as a treatment in hematopoietic stem cell transplantation.
2023-03-29 AKARI Therapeutics Regulatory Poland and U.K. Regulatory Authorities – URPL and MHRA – Approve Use of New, Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Study akaritx.com ↗
2022-11-10 AKARI Therapeutics Regulatory Akari Therapeutics Granted FDA Rare Pediatric Disease Designation of Nomacopan for the Treatment of Pediatric HSCT-TMA akaritx.com ↗
The Rare Pediatric Disease Designation is an important addition to the Orphan Drug and Fast Track designations previously granted by the FDA for nomacopan in pediatric HSCT-TMA.
2022-07-28 AKARI Therapeutics Results Akari Therapeutics Announces Positive Results from Recent Pre-Clinical Studies of Investigational PASylated® Nomacopan That Support the Potential to Advance Research Toward IND/IMPD for Clinical Trials in Geographic Atrophy akaritx.com ↗
Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on developing advanced therapies for autoimmune and inflammatory diseases, today announced positive results from recent pre-clinical studies on the tolerability and extended dose interval of long-acting PAS-nomacopan in development for geographic atrophy (GA) in dry age-related macular degeneration (dAMD).
2022-07-07 AKARI Therapeutics Results Akari Therapeutics Announces First Patient to Complete Course of Treatment in the Phase III Part A Clinical Trial of Investigational Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA) akaritx.com ↗
One patient completed more than 60 days of nomacopan treatment and subsequently was discharged from the hospital.
2022-05-19 AKARI Therapeutics Results Akari Therapeutics Presents Results from the CASCADE and CORONET Studies in COVID-19 at the American Thoracic Society (ATS) 2022 Annual Meeting akaritx.com ↗
Six patients who received the full course of treatment with nomacopan in the CORONET study survived and were discharged from the hospital.
2022-05-10 AKARI Therapeutics Results Akari Therapeutics Announces Publication of Phase II Data of Investigational Nomacopan for the Treatment of Bullous Pemphigoid (BP) in JAMA Dermatology akaritx.com ↗
Seven of nine patients responded to nomacopan with three, regarded as complete responders, showing >80% reduction in BPDAI (BP disease activity index)activity and four patients showing >70% reduction in pruritis by day 42; two of nine patients were non-responders
2022-05-09 AKARI Therapeutics Results Akari Presents Results from Two Preclinical Development Programs of Long-Acting PAS-Nomacopan in Geographic Atropy (GA) Dry Age-Related Macular Degeneration and Nomacopan in Experimental Immune-Mediated Conjunctival Disease (EIC) akaritx.com ↗
Akari Therapeutics, plc (Nasdaq: AKTX), a late-stage biotechnology company focused on the development of advanced therapies for autoimmune and inflammatory diseases, presented positive results from two preclinical studies of its lead asset, investigational nomacopan, in diseases of the eye at the Association of Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting.
2022-02-28 AKARI Therapeutics Results Akari Therapeutics Announces New Data Showing A Significant Role for Complement Activation in the Clinical Outcomes of U.S. Army Trauma Patients in Iraq and the Therapeutic Potential of Nomacopan for Treatment of Trauma akaritx.com ↗
Akari’s complement and leukotriene inhibitor, nomacopan, demonstrated improved survival (80% vs. 30%) in a preclinical model of trauma
2022-01-19 AKARI Therapeutics Regulatory FDA Agrees to Use of New Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Studies akaritx.com ↗
the U.S. Food and Drug Administration (FDA) has agreed, via a Type C meeting, to the clinical use of nomacopan derived from a next generation manufacturing process.

All press releases naming this drug 77 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as Coversin ClinicalTrials.gov intervention name — accepted as the source's own label NCT03427060 ↗
1

NCT02591862 ↗

Known as Nomacopan “Please note, 'Coversin' is used throughout, but Nomacopan is the official name/INN.” NCT02591862 ↗
2

NCT05061771 ↗

NCT04784455 ↗

Known as rVA576 “Drug: nomacopan (rVA576)” NCT05061771 ↗
1

“nomacopan (rVA576)” NCT04784455 ↗

Action Inhibit “prevents the cleavage of C5 by C5 convertase” NCT02591862 ↗
Modality Protein / enzyme biologic “a small protein complement C5 inhibitor” NCT02591862 ↗
Route Subcutaneous “treated with Coversin by daily subcutaneous injection” NCT02591862 ↗
Target C5 “prevents the cleavage of C5 by C5 convertase” NCT02591862 ↗