Press Release: Amyndas Pharmaceuticals Announces Positive Results from a Phase I Trial of its complement C3 inhibitor AMY-101

December 13, 2017

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. The phase I which has just been completed, was a prospective, single-center, open-label, First-In-Human (FIH) clinical study, designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after a Single Ascending Dose (SAD) and Multiple Doses (MD) of AMY-101 administered systemically (via the subcutaneous or intravenous route) in healthy male volunteers.

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.

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Study on inhibiting pre-exisiting natural periodontitis with Cp40 receives high Altmetric score

May 13, 2016

The study titled “Inhibition of pre-existing natural periodontitis in non-human primates by a locally administered inhibitor of Complement C3” led by Dr. George Hajishengallis and Dr. John Lambris has been recently assigned a high Altmetric score. Specifically, an Altmetric score serves as “an indicator of the amount of attention that a [research output] has received” from news outlets, as well as multiple social media sites. With a score of 190, this study is in the top 5% of all research outputs ever tracked by Altmetric. Additionally, this study is the #1 research output from its source, the Journal of Clinical Periodontology; specifically, it is ranked #1 out of 587 outputs from this particular journal.

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Study on reversing periodontitis with Cp40 features on 6 ABC Action News

April 9, 2016

The study titled “Inhibition of pre-existing natural periodontitis in non-human primates by a locally administered peptide inhibitor of complement C3” led by Dr. John Lambris and Dr. George Hajishengallis was recently featured on 6 ABC Action News. The study, which was published in the Journal of Clinical Periodontology, has provided new hope for “millions of Americans,” as the video notes, for a treatment that may effectively reverse periodontitis. The study delivered Cp40, an inhibitor of protein C3, to the periodontal tissue just once a week. This reversed naturally occurring chronic periodontitis inflammation in a preclinical model, and “gums were looking much healthier” in the used animal model, the video also states.

To watch news clip: Cp40 reverses periodontitis

April 1, 2016

George Hajishengallis, Thomas W. Evans Centennial Professor at the School of Dental Medicine at the University of Pennsylvania, gave an interview to regarding the potential for Cp40 to serve as an adjunctive therapy to the management of human chronic periodontitis. He discussed a current study, the result of eight years of collaboration with Dr. John D. Lambris, in which the C3 inhibitor Cp40 was administered to the periodontal tissue just once a week and was found to reverse naturally occurring chronic periodontitis in a preclinical model. The researchers found that Cp40 inhibited pre-existing gingival inflammation (as determined by both clinical and laboratory assessment) and the formation of osteoclasts, which are the cells involved in the resorption of bone. Hajishengallis further discussed recommendations for future studies.

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Press Release: Penn team reverses signs of naturally occurring chronic periodontitis

March 8, 2016

A study published in the Journal of Clinical Periodontology led by George Hajishengallis, Thomas W. Evans Centennial Professor in Penn’s School of Dental Medicine’s Department of Microbiology, and John D. Lambris, Dr. Ralph and Sallie Weaver Professor of Research Medicine in the Perelman School of Medicine’s Department of Pathology and Laboratory Medicine, has provided new hope that periodontitis can be effectively reversed. The study delivered Cp40, an inhibitor of protein C3, to the periodontal tissue just once a week, and this reversed naturally occurring chronic periodontitis inflammation in a preclinical model. This study builds on earlier work by Hajishengallis, Lambris and colleagues which identified C3 as a promising target for treating periodontal disease. In the future, the researchers are planning to pursue a Phase 1 safety and efficacy study in human volunteers.

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Press Release: Amyndas’ lead candidate AMY-101 receives orphan drug status from the FDA and the EMA for the treatment of C3 glomerulopathy

March 4, 2016

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). Specifically, AMY-101 is the first drug to be granted an orphan drug status by the EMA and the U.S. FDA for the indication of C3G. Currently, there is no treatment for C3G. Since the pathology of C3G is due to malfunction of the alternative pathway (AP) of complement, inhibition of complement component C3 is a promising strategy for the development of an effective treatment. Indeed, recent studies have shown that AMY-101 inhibits complement dysregulation in C3G in vitro, presenting a promising therapeutic opportunity and potentially a major advancement for patients with C3G.

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Press Release: The Aplastic Anemia & MDS International Foundation supports Amyndas Pharmaceuticals’ novel complement inhibitor AMY-101

September 23, 2015

The Aplastic Anemia & MDS International Foundation (AA&MDSIF) is endorsing the clinical development of Amyndas’ lead candidate AMY-101, as a novel treatment for paroxysmal nocturnal hemoglobinuria (PNH). The AA&MDSIF has awarded Dr. Risitano (Federico II University) and Dr. Calado (University of Sao Paolo) a grant to fund the first clinical trial of AMY-101 in untreated PNH patients. Both are distinguished experts in PNH research. Following extensive pre-clinical development and evaluation, AMY-101 was found to provide complete and sustained complement inhibition. The C3 complement inhibitor is expected to be effective in patients suffering from PNH, even those who do not fully benefit from the current complement-directed standard treatment.

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Press Release: What’s eating the erythrocytes?

July 9, 2015

A recently published study in Blood has given more support to “the concept that complement inhibition at the level of C3 rather than C5 will hopefully confer better therapeutic benefits for PNH patients because it will prevent destruction of red blood cells both inside and outside of vessels.” Such a therapeutic possibility is compstatin, a C3 inhibitor drug in development that was recently licensed by Amyndas Pharmaceuticals. Clinical trials for the resulting drug candidate are set for 2015 and 2016.

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Amyndas participates in a major publication on Paroxysmal Nocturnal Hemoglobinuria (PNH)

February 17, 2015

A new review article titled “Compstatin: a C3-targeted complement inhibitor reaching its prime for bedside intervention.” by Mastellos et al., has been accepted for publication in the European Journal of Clinical Investigation. The review analyzes why complement component C3 represents an attractive target for therapeutic modulation of the complement cascade and describes in detail the optimization effort which has led to the structure-function refinement of compstatin and its novel derivatives such as AMY-101, with improved inhibitory potency, pharmacokinetic profile and efficacy in a number of clinically relevant primate models of disease. The review discusses translational challenges in complement drug discovery and peptide drug development and analyzes concerns related to systemic C3 interception; despite existing challenges, AMY-101 emerges as a highly promising complement inhibitor therapeutic.

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Amyndas features in two of the widest-read Greek national Sunday newspapers

November 23, 2014

As a winner in the 2015 “Innovation Project” organized  by the Association of Pharmaceutical Companies in Greece, Amyndas enjoys significant exposure in the local press and media in Greece. The science news source from two Greek Sunday newspapers, Kathimerini (November 16, 2014) and Makedonia (November 23, 2014) posted an informative profile of Amyndas, describing the company’s novel technology licensed from the University of Pennsylvania, the wide range of potential therapeutic applications and the profound impact that these new therapies can have for patients and health care systems internationally. The articles (in Greek) created significant reader’s interest.

To read both articles (in Greek): Kathimerini and Makedonia