Compound Profile - Diabetic Peripheral Neuropathy Compound

Compound	Diabetic Peripheral Neuropathy
US Patent Number(s)	6,555,573   -   7,083,813
Regulatory Category	Ethical Pharmaceutical
Area Under Investigation	Reduce oxidative stress and the symptoms associated with Diabetic Peripheral Neuropathy
Indication	For the pain and discomfort associated with Diabetic Peripheral Neuropathy
Description	Concentrated and standardized nutrient based active compounds dosed in a topical cream designed to reduce oxidative stress and treat symptoms of Diabetic Peripheral Neuropathy, a nerve disorder that can lead to numbness, skin ulcers, constant pain or extreme sensitivity to a stimulus.
Proposed Administration	Topical hydrophilic cream
Development Phase	QR- 333   Investigational New Drug  # 67,168   Phase II
Research Path	QR – 333 human trials under IND have commenced. A safety and efficacy trial on patients with Diabetic Peripheral Neuropathy is scheduled. Efficacy will be assessed by relief of symptoms and improvement of quality of life.

Due to the Topical nature of Compound 333 and the low levels of systemic absorption seen in pre-clinical, as well as human safety studies, the compound may present a safer alternative to drug therapies currently on the market for Diabetic Peripheral Neuropathy.    QR-333 may have significant advantage over current drugs treating Diabetic Peripheral Neuropathy insofar as most of the current drugs to treat DPN are  anti-convulsants, analgesics and anti-depressants that pose a wide opportunity for side effects.  QR-333 has the potential to provide relief from symptoms while being safer than current gold standard treatment options.  Phase 3 endpoints will focus on symptom relief.  Phase 4 endpoints may focus on disease modification.   

Market    
   
Significant unmet need exists for a safe topical Diabetic Peripheral Neuropathy product with a low incidence of side effects.

If Treatment endpoints for this compound meet current treatment results for existing anti-convulsive agents but with QR333 proving to have a superior safety profile, these benefits could position the product for achieving significant market share in this therapeutic category.

Research History 

2006
Quigley Pharma began human studies on its investigational new drug, QR-333 after receiving no comments on the Investigational New Drug (IND) application it submitted in March. Patient screening and enrollment began in April for the first of two human trials designed to determine the safety pharmacokinetics of the compound, and a phase II(b) efficacy and safety study was planned after the pharmacokinetic study ends.

2005
Two pre-clinical toxicity studies of QR-333, one on hairless guinea pigs, the other on Gottingen minipigs, found the compound was safe for topical application. The testing on the guinea pigs concluded no evidence of primary irritancy, phototoxicity, contact hypersensitivity or photoallergy in response to topical administration of placebo or the QR-333 cream at a dose as high as 0.6 ml. The study on the minipigs revealed no difference in the dermal response to either active or placebo creams. The results of the clinical observations included ophthalmologic examinations, electrocardiograms, clinical pathology studies and necropsy, none of which suggested any event that could be related to an adverse systemic effect.

2003
A proof of concept study for QR-333 found that subjects taking the compound saw a 67 percent improvement of their symptoms , strongly suggesting efficacy. The double-blind, placebo-controlled study randomized 30 participants. Efficacy was evaluated using a quality of life questionnaire and symptom assessment. After four weeks of treatment, the active group substantially outperformed the placebo group in 13 out of 14 quality of life parameters. They also fared significantly better on symptom assessment, particularly irritation of the feet due to socks or sheets and numbness and tingling of the feet.
The study and results were accepted for publication on 31 May 2005, A double-blind, safety study of QR333 for the treatment of symptomatic diabetic peripheral neuropathy A preliminary report. Journal of Diabetes and its Complications 19 (2005) 247-253.