Nanotherapeutics, Inc., a privately held biopharmaceutical company, announced that it has acquired in bankruptcy proceedings two late stage clinical programs: Ramoplanin from Oscient Pharmaceuticals Corporation and PRX-3140 from EPIX Pharmaceuticals, Inc. Ramoplanin - an oral antibiotic for the treatment of Clostridium difficile-associated disease (CDAD) - is entering Phase 3 trials. PRX-3140 - an orally-bioavailable Alzheimer's treatment - is in Phase 2 clinical studies. Nanotherapeutics also acquired the U.S. and foreign patent estates covering each clinical program.
CDAD ranges from uncomplicated diarrhea in its mildest form, to fulminant colitis and death, in its most severe form. The incidence and severity of CDAD has increased with the emergence of virulent strains creating a growing unmet need. Ramoplanin, an orally administered drug, represents a potential new method for managing certain pathogens commonly found in the hospital. Following oral dosing Ramoplanin exerts its bactericidal activity locally in the GI tract and is not absorbed systemically. Ramoplanin has been shown to be bactericidal in vitro against C. difficile and other gram-positive bacteria and has been studied through Phase 2 clinical trials. A Phase 3 non-inferiority trial against vancomycin is planned pursuant to a Special Protocol Assessment agreed to by the FDA.
CDAD was mainly a concern in older or severely ill patients who were hospital inpatients or residents of long-term--care facilities. An increase of CDAD cases has been reported in the U.S., Australia, Canada, and the United Kingdom. Currently, it is estimated that 400,000 - 500,000 cases of CDAD occur each year in the U.S., with the incidence apparently doubling from 1996 to 2003, including a five-fold increase in those 65 and older. In the U.S., the disease generates in excess of $2.8 billion annually in hospital health care costs.
PRX-3140 is intended to stimulate cognition and memory by selectively activating the 5-HT4 G-protein coupled receptor in the brain to produce and release acetylcholine, a neurotransmitter that plays a role in learning and memory. As Alzheimer’s disease progresses, acetylcholine production declines, and brain levels of this critical neurotransmitter decline also. PRX-3140 may potentially slow the progression of the disease with fewer and less severe side effects than certain current Alzheimer drugs. A randomized, double-blind, placebo-controlled Phase 2a clinical trial was completed to assess the effects of PRX-3140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept®) in patients with mild Alzheimer's disease. In this study, PRX-3140 appeared to be well tolerated alone and in combination with Aricept® with no serious drug-related adverse events reported.
In October, 2009, the FDA permitted a Physician-Sponsored IND and continuation of the fourth six-month open label extension of PRX-3140.
Alzheimer’s disease is the most common form of dementia, affecting more than five million Americans and over nine million worldwide. The National Institute of Aging estimates that about five percent of the population aged 65-74 and as many as 50% of the US population over 85 have the disease. The global market is projected to grow from $4 billion in 2006 to over $5 billion in 2010. The disease is currently incurable and manifests as progressive memory loss, confusion, and ultimately loss of control of physical and mental functions leading to death.
Nanotherapeutics, Inc. is a privately held biopharmaceutical company. Its product pipeline includes, an FDA-approved injectable biologic product (OrigenTM DBM, marketing partner Orthofix), an FDA filed product (NanoFUSETM bone graft), and other products in clinical trials including NanoDOX® and NanoBUPTM. The Company also has in-house GMP manufacturing to support additional products. The 10-year old company employs several platform technologies to manipulate and enhance the properties of drugs, has an experienced management and development team, and a pipeline of clinical and pre-clinical pharmaceutical and biologic products.