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.
This FIH study was conducted at HPCTC, the largest commercial clinical research facility in North Carolina, founded in 2008 to execute complex early stage development and Proof of Concept studies in Patient populations.
“We have built HPCTC to be culturally aligned with highly engaged scientist-entrepreneurs like Dr. Lambris. It takes a special mentality to understand the urgency of his vision and operationalize it in the clinic for Amyndas in the most rigorous, compliant and adaptive way possible,” says Dr. Lorraine M. Rusch, President. “This concept is actually our mission, Science Driving Service.”
The AMY-101 protocol was driven by an adaptive approach that was ideally suited to meet trial objectives such as finding safe and effective doses via dose–response modeling as well as defining a therapeutic schedule of efficient complement C3 inhibition, via subcutaneous administration.
“FIH studies are generally the most exciting time of development where nonclinical data is translated into the clinical setting for the first time; Amyndas’ study was adaptively designed to maximize the amount of information which could be derived and required extremely close collaboration with Amyndas’ team to adjust dosing regimens, cohorts and routes of administration in a flexible and safe manner. Only a close medical, operations and Sponsor relationship could make such a challenging design successful,” added Dr. Rusch.
Analysis of the study results shows that AMY-101 has a very good safety profile across a wide range of administration routes and when administered in both single and multiple doses. Preliminary results indicate that AMY-101 has the pharmacokinetic and pharmacodynamic characteristics to support subcutaneous dosing every 48 hours resulting in appropriate complement C3 inhibition and providing new therapeutic options for patients with an array of complement-mediated diseases.
“We are excited about the results of the Phase I AMY-101 study. Inhibiting complement centrally, at the level of C3, which blocks all pathways of complement activation and through this mechanism, we expect that AMY-101 can provide a new therapy for Patients with several complement-mediated diseases. Already, results from clinical trials with other inhibitors targeting C3, have provided a good indication of this potential. Plans for phase II clinical studies of AMY-101 are currently underway,” added Dr. Despina Yancopoulou, Managing Director of Amyndas.
About Amyndas Pharmaceuticals
Amyndas Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics to treat a broad range of inflammatory diseases and disorders with unmet medical need, based on its patented technologies for modulating the complement system.
Amyndas is committed to developing the most advanced therapies to treat inflammatory disorders, in particular orphan diseases and conditions representing areas of unmet medical need for which patients need better and safer therapies. It has programs in Transplantation, the rare hemolytic disease Paroxysmal Nocturnal Hemoglobinuria (PNH), C3 glomerulonephritis, Periodontal Disease, Age-Related Macular Degeneration, Hemodialysis and Ischemia/Reperfusion Injuries.
About High Point Clinical Trials Center (HPCTC)
HPCTC was “born from biotech” in 2008 as an internal clinical research unit for TransTech Pharma (now vTv Therapeutics), a drug discovery and development company. As the largest commercial clinical research unit in North Carolina, HPCTC conducts First-in-Human, clinical Proof-of-Concept, and traditional IND/NDA-enabling clinical pharmacology phase I/II trials for Contract Research Organizations, biotechnology and pharmaceutical companies worldwide.
In addition to early development studies, HPCTC conducts studies across a range of therapeutic areas including metabolic disorders, pulmonary disease and CNS in a pleasant and comfortable environment managed by caring and experienced staff. Participant safety, protocol adherence, regulatory compliance and effective communication are the Company’s top priorities.
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High Point Clinical Trials Center
Doug Copeland, +1-336-255-2353
Executive Vice President
Amyndas Pharmaceuticals SA
Despina Yancopoulou, PhD, MBA, +30 (694) 722-1847