January 08, 2019Download pdf
Bresso (MI), Italy – January 8, 2019 - EryDel SpA (www.erydel.com), a biotech company specializing in the development and commercialization of drugs and diagnostics delivered through autologous red blood cells, today announced the appointment of Alyssa Wyant as Senior Vice President, Regulatory Affairs. Ms. Wyant will oversee all aspects of EryDel's international Regulatory and Quality activities and will report to EryDel’s Chief Executive Officer, Dr. Luca Benatti.
"The addition of Alyssa to the EryDel team comes at a critical time as the company further strengthens its management team," remarked Dr. Benatti. "Alyssa has extensive regulatory experience and an outstanding track record, having supported the advancement of multiple orphan products through the regulatory approval process and commercialization. Her experience will be invaluable to EryDel as we advance the clinical development of the EryDex system through our Phase 3 ATTeST study in Ataxia Telangiectasia and in moving the pipeline through development and to commercialization.”
Ms. Wyant has over 20 years of global regulatory experience with a focus on the development, registration and successful launches of innovative, biologic and small molecule orphan disease products. Most recently, Ms. Wyant served on the management team at Edge Therapeutics as Senior Vice President, Regulatory Affairs, where she was responsible for the strategic development of EG- 1962 in aneurysmal subarachnoid hemorrhage. Previous positions included serving as Vice President, Global Regulatory Affairs at PTC Therapeutics, where she oversaw the international regulatory activities for TranslarnaTM (ataluren) across five orphan disease indications, including Duchenne muscular dystrophy (DMD) and cystic fibrosis. Additionally, as Senior Director, International Regulatory Affairs at NPS Pharmaceuticals, Ms. Wyant created and implemented global strategies for the registration and post- approval activities for orphan disease products, supporting FDA approval for Natpara® for hypoparathyroidism, and the U.S. and EU launches for Gattex® / Revestive® for short bowel syndrome. She also held multiple leadership positions in global regulatory affairs over a nine-year period at Shire Human Genetic Therapies in the U.S. and Switzerland, where she was a key contributor in obtaining, maintaining, and extending registration of the enzyme replacement therapies Elaprase®, VPRIV® and Replagal®. She also held regulatory affairs positions at Vertex Pharmaceuticals and Genetics Institute/ Wyeth-Ayerst Pharmaceuticals. Ms. Wyant has a B.S. in cell and molecular biology from the University of Washington.
Ms. Wyant commented: “EryDel’s diversified pipeline can offer multiple opportunities to fulfil significant unmet medical needs. I am excited to join the team and contribute to advancing these products by pursuing regulatory strategies supporting development and commercialization activities that enable the company to navigate challenges successfully and achieve meaningful milestones.”
About Ataxia Telangiectasia
Ataxia Telangiectasia (AT) is a rare genetic disease caused by biallelic mutations in the ataxia telangiectasia mutated (ATM) gene, for which no established therapy is currently available. ATM encodes a PI3Kinase protein shown to play a pivotal role in response to DNA damage and cell cycle control. Homozygosity for ATM mutations result in a multi-systemic disorder, involving mainly the nervous and immune systems. The major clinical feature of AT is severe progressive neurodegeneration from early infancy. Specific features include progressive ataxia of the trunk and limbs, involuntary movements, oculomotor apraxia, difficulties with speech and swallowing, and delayed peripheral neuropathy. Other clinical features of patients with the classical phenotype include oculocutaneous telangiectasia, immunodeficiency with recurrent respiratory tract infections, radiosensitivity and an increased incidence of cancer.
EryDel SpA is a biotechnology company specialized in the development of drugs delivered through red blood cells (RBCs) by using a proprietary medical device technology. Its most advanced product, EryDex System (EDS) is under late stage development for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no established therapy is currently available. EryDex has received Orphan Drug designation for the treatment of AT both from the FDA and the EMA. A completed pilot Phase II trial in AT patients demonstrated statistically significant efficacy of EDS on both the primary and secondary efficacy measures. An international multi-center, Phase III pivotal study, ATTeST, is being conducted. EryDel has a pipeline of preclinical programs that use its proprietary RBC’s delivery technology for the treatment of other rare diseases.
The ATTeST project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 667946. Also, EryDel received the 2018 most innovative StartUp Italia Award.
Media contact: Emanuela Germi at +39 02 36504470 or firstname.lastname@example.org