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  • CHF 5074 is a novel, first-in-class small molecule microglia modulator created by Chiesi
  • Final results of a 14-week, double-blind, placebo-controlled Phase 2 study in 96 MCI patients and interim data from the 90-week open-label extension study indicate CHF 5074 reduces brain inflammation and improves cognition
  • CereSpir and Chiesi are negotiating a License Agreement, which will grant CHF 5074 global development and commercialization rights to CereSpir

July 26, 2013 – New York, NY, and Parma, Italy – CereSpir™ Incorporated and Chiesi Farmaceutici S.p.A. today acknowledged the Companies have entered into a Letter of Intent and are negotiating a Licensing Agreement, whereby CereSpir will acquire the exclusive global development and commercialization rights to CHF 5074, a novel, first-in-class small molecule microglia modulator that was discovered and developed by Chiesi researchers.

Upon execution of the License Agreement, Chiesi is committed to completing the ongoing long-term extension phase of the double-blind, placebo-controlled Phase 2 study in patients with mild cognitive impairment (MCI).  Forty-three patients are expected to reach the 90-week endpoint of the Phase 2 study at the end of 2013.  Chiesi has demonstrated CHF 5074 improves cognition and reduced brain inflammation in patients with mild cognitive impairment (MCI), and interim results from this study have been presented on July 16 at the Alzheimer’s Association International Conference 2013 (AAIC 2013) in Boston.  CereSpir will be responsible for the late-stage development of CHF 5074, regulatory filings, and commercial activities.

About CHF 5074
CHF 5074 is a small molecule with a unique microglial modulating mechanism of action capable of selectively reducing pro-inflammatory activities of microglial cells while increasing their ability to remove neurotoxic amyloid beta (“Aβ”) aggregates in the brain by phagocytosis.  Microglia are small cells that migrate through the brain to remove waste products, such as amyloid aggregates that cause inflammation and irreversible damage to nerve cells.  Chronic dysfunction of microglia is increasingly believed to play an important role at the very beginnings of Alzheimer’s disease.  The results from Chiesi’s human clinical studies corroborate the large body of data from published preclinical studies.  In Alzheimer’s disease transgenic mouse models, CHF 5074 was shown to reduce neuroinflammation, inhibit brain amyloid β plaque deposits, reduce tau pathology, and reverse associated memory deficits.  These findings indicate CHF 5074 acts simultaneously on several important therapeutic targets, and this multi-target approach may translate into preventing the memory loss that is the hallmark of Alzheimer’s disease.

AAIC 2013 highlighted CHF 5074 as one of four recent research trials investigating new targets for therapies in Alzheimer’s disease and incorporating novel approaches to participant identification and selection.

About Alzheimer’s disease, ApoE4, and Mild Cognitive Impairment
Alzheimer’s disease (AD) is the most prevalent neurodegenerative disease and the leading cause of dementia among the elderly.  More than 30 million people are afflicted with AD, with the associated estimated cost of care exceeding $200 billion annually, as patients live eight to ten years on average after diagnosis.  Today, AD remains the largest unmet medical need in neurology, with the disease expected to afflict 100 million by 2050.

Individuals who have the ApoE 4 gene are three to eight times more likely to develop AD than those who do not carry ApoE 4.  The level of risk partially depends on whether the person inherits one or two copies of the gene.  ApoE4 causes a more aggressive form of AD that is believed to involve a strong inflammatory response.

Mild Cognitive Impairment (MCI) causes cognitive changes that are serious enough to be noticed by the individuals experiencing them or to other people, but the changes are not severe enough to interfere with daily life or independent function; therefore, they do not meet diagnostic guidelines for dementia.  However, those with MCI, particularly ApoE4 carriers, have an increased risk of eventually developing Alzheimer’s or another type of dementia.

About Chiesi Farmaceutici S.p.A.
Founded in 1935 in Parma (Italy), the Chiesi Group achieved in 2012 a turnover of € 1,107 million, an increase of 4.7% in comparison with the previous year. The Group, whose main areas of activity are in respiratory therapies and specialist medicine, currently has 25 branches worldwide and is present in over 60 countries with its products, produced at the plants in Parma, Blois (France) and Santana de Parnaíba (Brazil).

In 2012 investment in R&D reached € 198 million, accounting for 18% of sales, a level that the company intends to maintain in coming years. The R&D operations in Parma, Paris, Rockville (USA) and Chippenham (UK) integrate their efforts to advance the Group’s pre-clinical, clinical and registration programs. At the end of 2012, the Chiesi Group employed over 3,800 people and more than 350 of them were involved in R&D.

About CereSpir Incorporated
CereSpir is dedicated to preserving the primary essence of each person, his or her memories.  The privately held company was founded by Daniel Chain, PhD, to focus exclusively on the final development of CHF 5074, upon the completion of a licensing agreement with Chiesi Farmaceutici S.p.A.  Dr. Chain is a seasoned, accomplished and knowledgeable entrepreneur, inventor and CEO who has spearheaded the development of several innovative therapeutic approaches in his unrelenting pursuit of a world without Alzheimer’s disease.