Drugs / AMY-101
AMY-101
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03316521 | Apr → Nov 2017 | — | Amyndas Pharmaceuticals S.A. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04395456 | Sep 2021 → Sep 2022 | acute respiratory distress syndrome | Amyndas Pharmaceuticals S.A. | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT03694444 Comparator | Jul 2019 → Aug 2020 | gingivitis | Amyndas Pharmaceuticals S.A. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2022-10-06 | Amyndas Pharmaceuticals S.A. | Results EUSTM (9th Congress): Novel Transformative Treatment for Periodontal Disease amyndas.com ↗
The preclinical efficacy of this C3-targeted drug combined with its excellent safety and pharmacokinetic profiles supported the use of AMY-101 in a recent Phase IIa clinical study, in which C3 inhibition resolved gingival inflammation in patients with periodontal disease. |
| 2022-08-22 | Amyndas Pharmaceuticals S.A. | Results Complement C3 inhibition in severe COVID-19 using compstatin AMY-101 amyndas.com ↗
We provide interim data from ITHACA, the first randomized trial evaluating a C3 inhibitor, AMY-101, in severe COVID-19 (PaO2/FiO2 ≤ 300 mmHg). |
| 2021-12-03 | Amyndas Pharmaceuticals S.A. | Results JCI Video: Complement C3 Inhibitor AMY-101 in Adults with Periodontal Inflammation – Clinical Trial amyndas.com ↗
The Journal of Clinical Investigation created a video illustrating that local delivery of the complement C3 inhibitor AMY-101 in patients with gingivitis was safe, well tolerated, and led to significant and sustained reduction of clinical indices of gingival inflammation. |
| 2021-10-08 | Amyndas Pharmaceuticals S.A. | Results JCI: Phase 2a clinical trial of complement C3 inhibitor AMY-101 in adults with periodontal inflammation amyndas.com ↗
A once-per-week intragingival injection of AMY-101 for 3 weeks was safe and well-tolerated in all participants resulting in significant (P<0.001) reductions in clinical indices measuring gingival inflammation (MGI and BOP). |
| 2021-03-21 | Amyndas Pharmaceuticals S.A. | Results Business Wire: Amyndas Announces Positive Top-Line Phase 2 Results for Investigational AMY-101 in Adults With Periodontal Inflammation and Gingivitis amyndas.com ↗
Amyndas Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of novel complement therapeutics, announced today positive top-line Phase 2 results from its randomized, placebo-controlled clinical trial evaluating AMY-101 in 39 patients with periodontal inflammation and gingivitis. |
| 2021-03-11 | Amyndas Pharmaceuticals S.A. | Results Iatronet.gr: Ελληνικό φάρμακο ανοίγει νέους δρόμους στη θεραπεία της περιοδοντίτιδας amyndas.com ↗
Η τοπική εφαρμογή του σε 39 ασθενείς στις ΗΠΑ, στο πλαίσιο τυχαιοποιημένης κλινικής δοκιμής Φάσης 2, έδειξε πως μπορεί να μειώσει σε μεγάλο βαθμό τη φλεγμονή και την αιμορραγία στα ούλα, μέσα σε διάστημα μόλις τριών εβδομάδων. |
| 2021-03-09 | Amyndas Pharmaceuticals S.A. | Results Amyndas announces positive top-line Phase 2 results for investigational AMY-101 in adults with periodontal inflammation and gingivitis amyndas.com ↗ |
| 2020-09-22 | Amyndas Pharmaceuticals S.A. | Results Το Βήμα: Κορωνοϊός: Ελληνικό φάρμακο για τους σοβαρά ασθενείς «νικά στα σημεία» amyndas.com ↗
το ΑΜΥ-101 «νικά στα σημεία» παρουσιάζοντας ευρύτερα θεραπευτικά οφέλη στους ασθενείς με COVID-19. |
| 2020-06-15 | Amyndas Pharmaceuticals S.A. | Results Το Βήμα: Ελληνικό φάρμακο ενάντια στην COVID-19 amyndas.com ↗
Χάρη στο καινοτόμο αυτό φάρμακο, το ΑΜΥ-101, που αποτελεί «τέκνο» της ελληνικής φαρμακευτικής εταιρείας Αμύντας, τρεις ασθενείς με λοίμωξη από SARS-CoV-2 στην Ιταλία, οι οποίοι είχαν εξαντλήσει τις διαθέσιμες θεραπευτικές επιλογές και «ακροβατούσαν» μεταξύ ζωής και θανάτου, επέστρεψαν νικητές στο σπίτι τους. |
| 2020-05-30 | Amyndas Pharmaceuticals S.A. | Regulatory Amyndas Initiates Phase 2 Trial of Complement Inhibitor AMY-101 in COVID-19 amyndas.com ↗
May 30th, 2020 – Amyndas Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of the most advanced C3 complement therapeutics, announced today that it received FDA approval to start its Phase 2 clinical study, evaluating the efficacy of AMY-101 in COVID-19 patients with acute respiratory distress syndrome (ARDS). |
| 2020-04-29 | Amyndas Pharmaceuticals S.A. | Results The first case of COVID-19 treated with the complement C3 inhibitor AMY-101 amyndas.com ↗
Herein, we report the clinical course of a patient with severe ARDS due to COVID-19 pneumonia who was safely and successfully treated with the compstatin-based complement C3 inhibitor AMY-101. |
| 2017-12-13 | Amyndas Pharmaceuticals S.A. | Results Press Release: Amyndas Pharmaceuticals Announces Positive Results from a Phase I Trial of its complement C3 inhibitor AMY-101 amyndas.com ↗
Amyndas Pharmaceuticals, which is committed to developing innovative therapeutics for complement-mediated conditions, today announced positive preliminary results from a Phase 1 clinical trial of its C3-targeted complement inhibitor, AMY-101. |
| 2017-12-13 | Amyndas Pharmaceuticals S.A. | Results Amyndas Pharmaceuticals Announces Positive Results from a Phase I Trial of its new complement C3 inhibitor AMY-101 amyndas.com ↗
Preliminary analysis of the study results shows that AMY-101 was safe, well tolerated, and that AMY-101’s PK / PD profile can support a therapeutic schedule of efficient complement C3 inhibition, via subcutaneous administration every 48 hours. |
| 2016-03-04 | Amyndas Pharmaceuticals S.A. | Regulatory Press Release: Amyndas’ lead candidate AMY-101 receives orphan drug status from the FDA and the EMA for the treatment of C3 glomerulopathy amyndas.com ↗
Amyndas Pharmaceuticals SA recently announced that its lead candidate, the C3 complement inhibitor AMY-101, has been granted orphan designation by the European Medicines Agency (EMA) and the U.S. FDA for the treatment of C3 glomerulopathy (C3G). |
| 2014-10-12 | Amyndas Pharmaceuticals S.A. | Regulatory Press Release: FDA grants orphan drug designation for PNH to Amyndas Pharmaceuticals’ novel complement inhibitor amyndas.com ↗
Amyndas Pharmaceuticals SA, the complement therapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted AMY-101, a potent complement C3 inhibitor, an Orphan Drug Designation for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). |
| 2014-08-27 | Amyndas Pharmaceuticals S.A. | Regulatory Press Release: EMA grants orphan drug designation for PNH to Amyndas Pharmaceuticals’ novel complement inhibitor amyndas.com ↗
Amyndas Pharmaceuticals SA, the complement therapeutics company, announced that the European Medicines Agency (EMA) has granted AMY-101, a potent complement C3 inhibitor, an Orphan Drug Designation for the treatment of Paroxysmal Nocturnal Hemoglobinuria. |
All press releases naming this drug 21 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AMY-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03316521 ↗ |
| Known as | Compstatin 40 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297260 ↗ |
| Known as | Compstatin analog peptide cp40 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297260 ↗ |
| Action | Inhibit | “AMY-101 inhibits the cleavage of native C3 to its active fragments C3a and C3b.” NCT03316521 ↗ |
| Modality | Peptide | “AMYNDAS is developing a novel peptidic complement inhibitor AMY-101” NCT03316521 ↗ |
| Route | Intravenous | “using subcutaneous (SQ) or intravenous (IV) administration” NCT03316521 ↗ |
| Route | Subcutaneous | “using subcutaneous (SQ) or intravenous (IV) administration” NCT03316521 ↗ |
| Target | C3 | “binds to the complement component C3” NCT03316521 ↗ |