AFFiRiS announces Phase 2 study in Parkinson’s and new focus on neurodegenerative diseases

- Proof of concept for AFFiRiS’ disease-modifying specific active immunotherapy (SAIT) achieved in cardiometabolic and neurodegenerative diseases

- Long-term safety data and novel treatment approach support further clinical development in Parkinson`s disease

AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs), today announced a realignment of its development strategy on neurodegenerative diseases, a core area of expertise of the company. Affiris will now focus on ongoing preparations of a phase 2 clinical trial to treat patients suffering from Parkinson’s disease.

AFFiRiS has achieved proof of concept of its unique AFFITOME technology in humans for hypercholesterolemia and Parkinson’s disease with respect to safety, specific antibody production, in vivo target engagement and clinical effect, including positive long-term safety data in Parkinson’s. The company’s focusing on neurodegenerative diseases such as Parkinson´s addresses the urgent medical need and a large attractive commercial opportunity.

Noel Barrett, Chief Executive Officer at AFFiRiS commented: ‘Neurodegenerative disease has always been AFFiRiS’ strength. The company’s work with cardiometabolic and neurodegenerative diseases has been a great journey, enabling us to refine our approach and prove that the technology works in multiple settings. We have taken the strategic decision to concentrate our skills and experience, using our deep understanding of targets and pathogenesis, to progress our exciting pipeline in neurodegenerative diseases.’

Rossella Medori, Chief Medical Officer at AFFiRiS added: ‘Patients with neurodegenerative diseases such as Parkinson’s disease face an all-too-predictable future and are in urgent need of therapies that alter the course of disease progression. Although there are many treatments available to manage the devastating symptoms, sadly none of these acts on the underlying cause of the disease. However, AFFiRiS’ unique immunological approach provides a disease-modifying therapy with an excellent competitive profil in the field of neurodegenerative treatments.’

Michael Motschmann, chairman of AFFiRiS’ supervisory board, said: `We are very pleased about the significant progress of the company under new leadership. The great expertise in neurodegenerative diseases and the unique treatment approach the company is applying to Parkinson`s disease, holds a great promise for patients and care takers. ‘

About the AFFITOME technology and SAITs:

AFFiRiS has devised a unique immunological approach – AFFITOME technology – which mimics the epitopes of pathologic forms of proteins. The result is a treatment modality called specific active immunotherapy (SAIT). It harnesses the power of the body’s own immune system to target rogue proteins that are involved with the development and progression of neurodegenerative diseases. It stimulates the immune system to produce antibodies against potentially pathologic forms of these proteins, helping the body to eliminate them. Via this mechanism, the aim is to inhibit disease progression and improve the lives of patients.

The AFFiRis Leadership Team:

Noel Barrett, PhD, former Vice President of Research & Development Vaccines at Baxter Healthcare took over the role as Chief Executive Officer at AFFiRiS in March 2019. Dr. Barrett has more than 30 years of experience in the vaccines and biologics industry bringing products through the development process to the market. He led the development and licensure of Baxter’s FSME tick-borne encephalitis vaccine, Meningococcal C vaccine, and cell‑culture derived H5N1, H1N1, and seasonal influenza vaccines. His contribution to the Baxter scientific community was recognized with the title of Baxter Distinguished Scientist, the most prestigious scientific recognition within the company, and the Baxter Bioscience President’s Leadership Award.

Rossella Medori, MD, has accepted the role as Chief Medical Officer in March 2019. Dr. Medori brings more than 20 years of neuroscience expertise to AFFiRiS and has an extensive track record in successful CNS drug development. Before joining AFFiRiS, she led Prexton Therapeutics to a successful early exit, had key leadership roles at Biogen (including Vice President of Translational Neurology and Vice President of Late Clinical Development) and served in European and Global Medical leadership roles at Janssen-Cilag, BMS and Lilly. Rossella practiced as a Clinical Neurologist in Italy, the United States and Germany and held various academic positions at Case Western Reserve University, Washington University and Columbia University. The identification of the DNA mutations associated with different forms of muscular dystrophy and the description of a new prion disease called Fatal Familial Insomnia are among her most important scientific contributions.

Günther Staffler, PhD, is Chief Technology Officer at AFFiRiS, where he is responsible for preclinical development and technology. Prior to his appointment to the executive board, Günther led the immunology department. Before Joining AFFiRiS, he held various positions at Intercell and Biovertis AG, which he co-founded. Günther completed his doctorate degree in biochemistry and immunology at the Institute of Immunology, University of Vienna, Austria, and has authored many publications in international journals. He was awarded the “Förderungspreis” from the Austrian Society of Chemistry in 1996 and the “Fritz and Ursula Melchers Preis” from the Austrian Societ of Immunology in 2003.

Supplementary information:

About AFFiRiS

About SAIT

About neurodegenerative diseases

About Parkinson’s disease

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