Catalent & Cerenis Therapeutics Announce Phase III Trial of CER-001
Somerset, N.J. – January 28, 2016 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, consumer health and animal health products, today announced that Cerenis Therapeutics has advanced its leading clinical candidate, CER-001, into Phase III clinical studies across Europe and North America. The phase III TANGO trial was initiated in October 2015, to evaluate efficacy to regress atherosclerosis, and safety of CER-001 in patients with Familial Primary HypoalphAlipoproteinemia (FPHA).
Cerenis Therapeutics’ CER-001 candidate is an engineered complex of recombinant human apoA-I, the major structural protein of High-Density Lipoprotein (HDL) and phospholipids. The development of CER-001 has leveraged Catalent’s proprietary GPEx® technology, which creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial scale production.
To date, six GPEx based antibody and protein products are approved and marketed and 34 therapeutic candidates are currently in the clinic across the world.The TANGO trial is a multicenter, randomized, 48-week, double-blind, parallel-group, placebo-controlled study involving thirty patients from several sites across Europe, Canada, the United States and other countries based on availability of patients with this rare orphan disease.
Dr. Jean-Louis Dasseux, Founder and CEO of Cerenis commented, "The partnership established with Catalent Biologics has empowered us to resolve a 30 year challenge: the production of a commercially viable HDL mimetic, by generating a proprietary CHO cell line with a high apoA-I expression via secretion meeting the demanding quality standards we require for our clinical study drugs. The Phase III TANGO trial will fully benefit from GPEx technology and we are convinced its application to the production of CER-001 batches will ensure better product safety and product quality. These features are particularly encouraging with regards to CER-001’s filing for future market approval expected in 2018.”
“GPEx technology was designed to offer clients and partners advantages over conventional cell line engineering systems, including increased flexibility and higher, more stable yields,” commented Mike Riley, Vice President and General Manager of Catalent Biologics. “We are pleased to have worked with Cerenis to help advance their life-changing therapy into Phase III studies, and this represents another key milestone for our GPEx platform as an enabling technology.”
Catalent performs GPEx programs at its state-of-the-art biomanufacturing facility in Madison, WI, which was completed in June 2013. Designed for flexible cGMP production from 10 L up to 1,000 L, and non-GMP production up to 250 L, the site features extensive single-use technologies and unidirectional flow to maximize efficiency and safety.
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About Cerenis Therapeutics
Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies for the treatment of cardiovascular and metabolic diseases. HDL is the primary mediator of the reverse lipid transport, or RLT, the only natural pathway by which excess cholesterol is removed from arteries and is transported to the liver for elimination from the body.Cerenis is developing a portfolio of HDL therapies, including HDL-mimetics for the rapid regression of atherosclerotic plaque in high–risk patients such as post–ACS patients and those with HDL deficiency, and drugs which increase HDL for patients with low number of HDL particles to treat atherosclerosis and associated metabolic diseases.Cerenis is well–positioned to become one of the leaders in the HDL therapeutic market, with a broad portfolio of programs being developed.Cerenis is currently evaluating CER-001 in two clinical trials: a phase II clinical trial (CARAT study) for the treatment of patients post Acute Coronay Syndrome (post-ACS) and a phase III clinical trial (TANGO trial) for the treatment of Familial Primary HypoAlphalipoproteinemia (FPHA, HDL deficiency). Since its inception in 2005, the company has been funded by top tier investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and Bpifrance (Fund for Strategic Investment) and last March successfully completed an IPO on Euronext raising €53.4m.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, consumer health and animal health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,700 people, including over 1,000 scientists, at 31 facilities across 5 continents, and in fiscal 2015 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com