May 11, 2015Download pdf
Urbino, Italy – May 11, 2015 - EryDel SpA (www.erydel.com), a Company specialized in the development of drugs and diagnostics delivered through autologous red blood cells, today announced that has expanded its Series B financing to € 29,5m. In 2013, EryDel announced a €15m Series B financing, led by Genextra SpA, a leading Italian life sciences investment firm, with existing investors Innogest SGR and Focus Gestioni SGR also participating.
The increased resources will be used to complete the planned development of EryDex for the treatment of neurological symptoms of Ataxia Telangiectasia (AT), a rare autosomal recessive disorder for which no established therapy is currently available.
EryDel is about to initiate a single, comprehensive, confirmatory, placebo-controlled Phase III trial that will determine the efficacy and safety of EryDex in AT. A recently completed pilot Phase II trial demonstrated statistically significant efficacy of EryDex on both the primary and secondary efficacy measures.
EryDel has obtained Orphan Drug designation for EryDex in the treatment of AT both from the FDA and the EMA.
Luca Benatti, CEO of EryDel, said: "we are very pleased that our investors continue to show confidence in our ability to complete Phase III development package required for the filing of the regulatory dossier of our lead product EryDex for the treatment of neurological symptoms of this devastating disease”.
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 or compound heterozygosity for ATM mutations result in a multi-systemic disorder, mainly involving the nervous and immune system. The major clinical feature of AT is severe progressive neurodegeneration with onset in infancy. These features include ataxia of the trunk and limbs, progressive supranuclear ophthalmoplegia, dysarthria, swallowing incoordination, facial hypomimia 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 Drug Delivery Company specialized in the development of drugs and diagnostics delivered through red blood cells (RBCs) by using a proprietary medical device technology. The most advanced product, EryDex (Dexamethasone Sodium Phosphate delivered through autologous RBCs), has potential for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no established therapy is currently available. EryDex received Orphan Drug designation for the treatment of AT both from the FDA and the EMA. A recently completed pilot Phase II trial in AT patients demonstrated statistically significant efficacy of EryDex on both the primary and secondary efficacy measures. EryDel has a pipeline of preclinical programs that use its proprietary RBC’s delivery technology for the treatment of other rare diseases.
About Genextra SpA
Genextra is dedicated to identifying, validating and backing emerging discoveries in the life sciences sector and to fostering their development into novel therapies and tools. Genextra was created in 2004 by a group of prominent Italian entrepreneurs and financial institutions. To date, Genextra has raised nearly €120 million and represents one of very few examples in Italy of private capital invested for the benefit of research and innovation.
Innogest SGR is the Italian venture firm with offices in Turin, Milan and New York investing in innovation driven and fast growing companies. Since 2007, Innogest’s management team has built a solid experience in backing dynamic and innovative entrepreneurs and in transforming Italian companies into global leaders investing. As of today Innogest manages over €140 million across 2 funds.
About Focus Gestioni SGR
Focus Gestioni SGR, investment company of the Banca Marche Group, is the management company of the Focus Impresa and Focus Impresa II funds, investing in small and medium enterprises with and early stage companies with ambitious development plans and mainly located in the central regions of Italy. Based in Jesi (An), Focus actually manages more than €50 million.
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