New York, NY – September 30, 2014 – CereSpir™ Incorporated, a company developing CSP-1103, a first-in-class microglial modulator, as a potential treatment for Alzheimer’s disease (AD), announced today it has appointed former pharmaceutical senior executive Adrian Hobden, Ph.D., as Chairman of its Board of Directors. Dr. Hobden has a long and distinguished career in the global pharmaceutical industry responsible for development and commercialization of drug products across multiple therapeutic areas, including AD.
CereSpir™ Incorporated is developing CSP-1103, an orally delivered tablet, as a potential first disease-modifying treatment for AD targeting the very earliest stages of the disease. CSP-1103 has undergone Phase 2 testing in people with Mild Cognitive Impairment (MCI), and CereSpir is integrating the findings to finalize the Phase 3 clinical protocol in consultation with key opinion leaders in AD research and the U.S. Food and Drug Administration. The Company aims to initiate Phase 3 trials in 2015.
Dr. Hobden’s esteemed career includes as President of Myriad Pharmaceuticals, a wholly owned subsidiary of Myriad Genetics, which he founded in 1998 and grew into an integrated R&D organization of 220 employees with responsibility to manage the largest placebo controlled trial of an experimental Alzheimer medicine that had ever been run. Myriad Pharmaceuticals was later spun out as a public company called Myrexis with Dr. Hobden as CEO. He retired from Myrexis in 2011. Hobden earned his Bachelor’s and Master’s degrees in Biochemistry from Cambridge University and a Ph.D. in Molecular Biology from Leicester University, both in the U.K. He also completed a postdoctoral fellowship with the Medical Research Council in the U.K. Hobden began his industry career at Glaxo in the UK as a research scientist in 1981 and went on to run their Genetics Department and several others, including CNS Pharmacology. He moved to the United States in 1996 and was responsible for Glaxo’s collaborations with biotechnology companies. Currently, Dr. Hobden is also a board member at Zocere Inc, a startup biotechnology company focused on the development of novel compounds for the treatment of stroke and brain trauma and at The Hope Funds for Cancer Research.
“I am delighted to welcome Adrian as Chairman, a role for which he is eminently suited as we embark on CereSpir’s important mission to deliver a safe, effective and affordable disease modifying treatment targeting the earliest stages of Alzheimer’s disease” said Daniel G. Chain, Ph.D., Founder, President and Chief Executive Officer of CereSpir. I am confident that Adrian’s enormous breadth of experience, deep knowledge and leadership qualities will enrich our efforts for the ultimate benefit of millions of victims of Alzheimer’s disease around the world.
CSP-1103 is a novel, first-in-class, small molecule microglial modulator that protects neurons and other cells in the brain. The Phase 2 clinical program generated preliminary safety and efficacy data in approximately 100 people half of whom received CSP-1103 for up to 2 years. Data from this study were presented at the Alzheimer’s Association International Conference in 2013 and 2014. CereSpir is working to finalize the Phase 3 clinical protocols in consultation with key opinion leaders in AD research and the U.S. Food and Drug Administration. The company aims to initiate the first Phase 3 trial in 2015. CSP-1103 has been shown to inhibit brain amyloid beta (Aβ) plaque deposition, reduce tau pathology and neuro-inflammation and reverse associated memory deficits in AD transgenic mouse models. Additionally CSP-1103 restores normal microglial function by increasing phagocytosis and decreasing production of pro-inflammatory cytokines. Chronic dysfunction of microglia is increasingly believed to play an important role at the very beginnings of AD with several newly discovered genetic risk factors supporting this idea. These effects of CSP-1103 may translate into preventing the memory loss that is the hallmark of AD. Microglia form an important part of the innate immune system of the brain and are small cells that migrate through the brain to remove waste products, such as the amyloid aggregates that cause inflammation and irreversible damage to nerve cells. CSP-1103 binds strongly and selectively with the intracellular domain of the amyloid precursor protein (AICD) and inhibits its translocation to the nucleus to prevent transcription of pro-apoptotic genes and activation of GSK-3β, a multifunctional enzyme that is strongly associated with AD pathology.
The results from previous human clinical studies are consistent with a large body of preclinical data. Thus, for example, CSP-1103 rapidly and dose-dependently lowered cerebrospinal fluid (CSF) levels of two markers of neuro-inflammation, sCD40L and TNF-α, both in healthy volunteers and in MCI patients while prolonged treatment resulted in a reduction in CSF Tau (a marker of neurodegeneration) and was associated with sustained cognition. Collectively, the preclinical and clinical studies suggest CSP-1103 acts as a microglial modulator capable of selectively reducing pro-inflammatory activities of microglial cells while increasing their ability to remove neurotoxic Aβ and Tau aggregates in the brain by phagocytosis.
CereSpir is planning to conduct a Phase 3 program for CSP-1103 using an enrichment strategy of biomarkers and other diagnostic criteria that would limit enrollment to patients with MCI due to AD.
About CereSpir™ Incorporated
CereSpir is a private pharmaceutical company in New York, New York, U.S.A., founded by Daniel G. Chain, Ph.D. The Company assumed full rights to CSP-1103 in November 2013 and became the official sponsor of the IND in March 2014. CSP-1103 is a novel, first-in-class, small molecule microglial modulator. In a Phase 2 trial in MCI patients, CSP-1103 was both well tolerated and appeared to both reduce brain inflammation and result in sustained cognition. MCI causes a slight but noticeable and measurable decline in cognitive abilities, including memory and thinking skills. Most people with MCI progress to an Alzheimer’s disease (AD) diagnosis which currently affects more than 5 million Americans, 7 million Europeans and, in total, about 44 million people worldwide according to the most recent report by the Alzheimer’s Association. Current treatments for AD are symptomatic and temporary. There are no drugs approved which slow or halt the mental decline associated with this terrible disease. CereSpir is leading the way with a completely novel approach to AD by reducing inflammation and increasing clearance of tissue debris in the brain. This novel approach targets aggregates of both beta amyloid (Aβ) and Tau protein that together cause irreversible damage to nerve cells and are the characteristic pathology of AD.