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LIBERTYVILLE, IL, United States

Patent
Vidasym, Inc. | Date: 2012-10-12

Compositions comprising ferrous and/or ferric iron compounds and fiber in a complex, methods for preparing such compositions of matter, and the use thereof for treatment of adsorbing certain accessible targets in the gastrointestinal tract and in an extracorporeal system, are provided herein.


Compositions comprising metal ions or clusters such as ferrous and/or ferric iron compounds or magnesium, zinc, lanthanum and other metal ion compounds and fiber components such as gum Arabic in a complex, methods for preparing such compositions of matter, and the use thereof for treatment of adsorbing certain accessible targets in the gastrointestinal tract and in an extracorporeal system, are provided herein.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 219.12K | Year: 2011

DESCRIPTION (provided by applicant): Twenty-six million people in America have chronic kidney disease (CKD). Anemia, cardiovascular diseases, secondary hyperparathyroidism, renal osteodystrophy and other complications are common in CKD. Current treatmentsincluding ACE inhibitors for CKD patients mainly focus on managing symptoms and disease complications. Despite the various treatments available, the five-year survival rate is ~33% and the mortality risk increases with kidney disease progression and secondary hyperparathyroidism. Vitamin D receptor modulators (VDRMs) have been shown to reduce proteinuria/albuminuria in CKD patients and also provide survival benefits for CKD patients. Despite encouraging data on VDRM's potential renal and survival benefits for the CKD patients, currently in the CKD field VDRM is only indicated for managing secondary hyperparathyroidism (with elevated PTH). Hypercalcemic toxicity that interferes with calcium homeostasis and detriments body functions is the limiting factor to expanded use of on-market VDRMs. Therefore, a novel VDRM which retains the efficacy without the toxicity shared by current VDRMs would have significant clinical benefit. An ideal VDRM should be with little or no hypercalcemic toxicity in the efficacious dose range that could reduce PTH and slow kidney disease progression. Vidasym has taken a unique drug discovery/development approach to discover novel VDRMs that are highly differentiated from existing VDRMs. Vidasym's Vida-5 has no detectable hypercalcemic toxicity in the dose range that suppresses PTH to the normal level (vs. other VDRMs with overlapping dose ranges for efficacy and toxicity). With Vida-5's superior safety and efficacy profiles established, the next step is to determine the feasibility of using Vida-5 to treat kidney disease progression and also its long-term side effect potential in animal studies. The specific aims of this Phase I study are: (1) to conduct an animal study to show the synergistic effect of Vida-5 and an ACE inhibitor on reducing biomarkers (such as serum creatinine and proteinuira) indicative of kidney disease progression; (2) to conduct a toxicity animal study to prepare Vida-5 for Phase II studies. Once this phase I study is completed the data will allow the advancement ofVida-5 into Phase II IND-enabling studies including Vida-5 synthesis scale-up, process development and pharmacokinetics, metabolism, safety and toxicology. The completion of Phase II studies will allow Vida-5 to enter human clinical trials. Vidasym plans to develop Vida-5 into a reimbursable prescription new drug to treat kidney disease progression. Once developed, such a drug will not only reduce the mortality rate of CKD, but also reduce the need for dialysis. Current VDRMs for secondary hyperparathyroidism alone achieve US 1+ billion in annual sales in 2009. Zemplar and Hectorol dominate the US dialysis market (gt80%) due to their slightly less hypercalcemic toxic profile (~2-4 fold less toxic than generic Calcijex, the endogenous hormone calcitriol,). Anovel VDRM such as Vida-5 for treating kidney disease progression could easily achieve an annual US sales at 1+ billion. PUBLIC HEALTH RELEVANCE: Vidasym's phase I SBIR study will determine the feasibility of using Vida-5 to treat chronic kidney disease (CKD) progression. Globally gt 350 million individuals have CKD and this number is projected to increase to gt550 million by 2025. Although various modalities and substances are available for CKD, the mortality rate for CKD patients remains high (~33%) and the number of dialysis CKD patients keeps increasing. There is an urgent medical need for the development of an effective and novel resuscitation approach for the treatment of CKD. Limitations of current therapy demonstrate that a new treatment approach such as Vida-5 to reduce the need for dialysis and also reduce the mortality rate of CKD offers a significant opportunity for improved outcomes with substantial societal benefit.


Patent
Vidasym, Inc. | Date: 2010-04-12

Disclosed is a compound of Formula (I) in which R1, R2, R3, R4, R5, R6, X, and a are defined herein, or a pharmaceutically acceptable salt thereof. Also disclosed are a pharmaceutical composition comprising a compound or salt thereof of Formula (I) and a method of treating a disease which benefits from the modulation of the vitamin D receptor, such as a bone disorder, cardiovascular disease, a cardiovascular complication associated with renal disease, endothelial dysfunction, hyperparathyroidism, hypocalcemia, an immune disorder, left ventricular hypertrophy, a proliferative disease, proteinuria, renal disease, and thrombosis.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.48M | Year: 2016

DESCRIPTION provided by applicant Osteoporosis is a major public health threat The American Association of Orthopaedic Surgeons estimates that the cost of treating patients with a low energy fracture in was US$ billion and projected costs for care of osteoporosis and low energy fractures over the next two decades are $ billion Current treatments for osteoporosis include several anti resorptive or anti catabolic and some anabolic agents VDRMs such as calcitriol are currently used to treat osteoporosis in several ex US countries VDRMs influence bone metabolism through regulation of intestinal calcium absorption parathyroid hormone receptor activator of nuclear factor kB ligand and also via direct effects on osteoblasts and osteoclasts Despite encouraging data on VDRMandapos s benefits for treating osteoporosis VDRMs are not used in osteoporosis patients in the US likely due to the fact that those currently on the market have substantial hypercalcemic toxicity that interferes with calcium homeostasis Consequently VDRM therapy requires frequent serum calcium monitoring and dose titration An ideal VDRM should be with little or no hypercalcemic toxicity in the efficacious dose range Since VDRMs are well known to have anabolic effects on the bone a VDRM without hypercalcemic toxicity for the treatment of osteoporosis will provide significant benefits to patients receiving the standard of care Vidasym has taken a unique approach to discover and develop novel VDRMs such as VS Data from extensive animal studies show that VS has an exceptionally wide therapeutic index TI at andgt fold vs TI of calcitriol at fold Results from SBIR Phase I confirm that VS exhibits potent anabolic effects on the bone in a dose range that does not affect serum calcium The mechanism of action studies demonstrate that while VS is potent in stimulating osteoblast activities osteoclast activitie are reduced leading to an increase in bone growth bone mineral density and bone volume These positive data strongly support the advancement of VS into Phase II SBIR The specific aims of this Phase II study are To complete synthesis and formulation of VS under Good Manufacturing Practice GMP in preparation for a Phase I clinical study To file an IND with the FDA for the indication of osteoporosis in preparation for a Phase I clinical study with VS Vidasym plans to develop VS into a reimbursable prescription drug to treat osteoporosis in patients receiving the standard of care According to a report from GBI Research the osteoporosis therapeutics market in was at $ billion and is forecasted to grow at a CAGR of to $ billion in An independent report by EvaluatePharma stated that osteoporosis medications achieved US$ billion in annual worldwide sales in and this number is likely to increase based on the projections of increased patient numbers Assuming Vidasymandapos s VS has a modest penetration into the osteoporosis market when launched in the estimated annual sales will be US$ billion PUBLIC HEALTH RELEVANCE Data from SBIR Phase I confirm that VS exhibits potent anabolic effects on the bone in a dose range that does not have side effects These positive data strongly support the advancement of VS into the next development phase which consists of manufacturing GMP compliant VS and filing an IND with the FDA in preparation for a Phase I clinical study The cost of treating patients with a low energy fracture in was US$ billion and projected costs for care of osteoporosis over the next two decades are $ billion Current treatments for osteoporosis have serious side effects and low compliance issues A new treatment approach such as VS that is efficacious with minimal toxicity offers a significant opportunity for improved outcomes with substantial societal benefit

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