News

Amyndas Pharmaceuticals Initiates Phase 2a study of AMY-101 in adults with Periodontal inflammation and Gingivitis

August 26, 2019

Amyndas Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of novel complement therapeutics, announced today the launch of its Phase 2a clinical study, evaluating AMY-101 in adults with periodontal inflammation and gingivitis. AMY-101 is a novel synthetic cyclic peptide designed to inhibit the complement cascade centrally at the level of C3 (Complement component 3).

Periodontitis is a clinical condition involving inflammation of the ligaments and bones that support the teeth. Periodontitis occurs when gingivitis goes untreated and persists. It is a significant cause of tooth loss in adults, and one of the most prevalent diseases worldwide, affecting around 20-50% of the population across the globe. Approximately 743 million people (about 11.2% of the global population) have a severe form of periodontitis that can raise the risk of cardiovascular disease, diabetes, arthritis, and pregnancy complications.

In an earlier Phase I study of AMY-101 in 50 healthy volunteers, AMY-101 was administered systemically and was found to be well tolerated with no serious adverse events. This new phase 2a trial of AMY-101 (ClinicalTrials.gov: NCT03694444) is a 3-month randomized, double-blind, split-mouth study in adults with existing chronic periodontal inflammation, determined by the level of the gingival index and bleeding on probing. In the trial, different halves of the mouth will be randomized (split-mouth design), and AMY-101 or placebo will be injected into the affected gingival tissues, once a week for three consecutive weeks. The primary endpoint of change in the gingival index will be evaluated at 21, 28, and 90 days after initial treatment.

To read the entire press release click here or visit SCIAD Newswire

To read the press release in Greek click here.

 
High Point Clinical Trials Center and Amyndas Pharmaceuticals Announce the Completion of the Complement C3 Inhibitor AMY-101 First in Human Study

March 30, 2018

High Point Clinical Trial Center (HPCTC) and Amyndas Pharmaceuticals jointly announce the completion of the AMY-101 First in Human (FIH) study, which assessed safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after a Single Ascending Dose (SAD) and Multiple Doses (MD) of AMY-101 administered systemically (via subcutaneous or intravenous routes) in healthy male volunteers.

AMY-101 is a C3-targeted complement inhibitor that has the potential to target a wide range of complement mediated conditions which are largely driven by aberrant C3 activation, such as PNH and C3G, as well as conditions where modulation of C3 could be beneficial, for example ABO-incompatible kidney transplantation, AMD, COPD and periodontal disease amongst others.

“AMY-101 is a third generation compstatin with significant improvements over previous generation molecules of the family of compstatins. The completion of the FIH study is major milestone in the clinical development of AMY-101 and the good safety profile observed demonstrates once again that inhibiting complement at the C3 level can be safely achieved in the clinic,” said Prof. John D. Lambris, founder of Amyndas and inventor of novel compstatin drugs, including AMY-101.

To read the entire press release: www.amyndas.com

 
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.

To read entire press release: www.sciadnewswire.com or www.amyndas.com

 
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.

To read more on the Altmetric score of this particular study: www.wiley.altmetric.com

To read more on how an Altmetric score is calculated: www.wiley.altmetric.com

 
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: www.youtube.com

 
MedicalResearch.com: 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 MedicalResearch.com 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.

To read entire interview: www.medicalresearch.com

 
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.

To read entire press release: www.news.upenn.edu

 
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.

To read entire press release: www.fiercepharma.com

 
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.

To read entire press release: www.fiercepharma.com

 
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.

To read entire press release: news.pennmedicine.org