BURLINGAME, Calif., Jan. 4 /PRNewswire/ -- Nascent Pharmaceuticals, Inc. announced positive results for a 90-patient Phase IIb clinical trial of iDESTRIN (NP50301), the company's topical ophthalmic therapeutic eye drop for treating Dry Eye Syndrome (DES) in postmenopausal women. The clinical trial was a randomized, vehicle controlled, double-masked study, with 30 patients in each of three arms receiving either vehicle, or one of two active doses; and enrolled patients with mild, moderate and severe disease. Data were collected for numerous subjective symptoms and objective signs throughout the 14-week trial period. The trial was designed to determine the appropriate endpoints and patient population for continued development.
In patients with moderate-to-severe disease, which was about half the patients enrolled, a significant improvement was achieved in the high dose group for the main objective endpoint, the Schirmer's Test, at 8 weeks (p=0.027) and 12 weeks (p=0.004), in both eyes versus vehicle. This represented an improvement of over 75% from baseline. This group also demonstrated a significant improvement at 12 weeks for two other objective endpoints, superficial punctuate keratopathy (p=0.020) and corneal staining (p=0.045). In the moderate-to-severe group, a significant improvement was achieved in both active dose groups for the main subjective endpoint, Foreign Body Sensation, at 4 weeks (p=<0.040) as compared to vehicle in both eyes, and this improvement was maintained throughout the study.
The results indicate that iDESTRIN therapy provides a benefit in relieving the signs and symptoms presented by DES in postmenopausal women. Importantly, there were no drug-related serious adverse events in the study.
"These positive results represent a major achievement for the company, and we look forward to moving ahead with the clinical program this year," said Clive Reading, Nascent Chief Executive Officer. "DES is a major unmet medical need, and we believe iDESTRIN may provide relief to millions of women who suffer from this uncomfortable and sometimes debilitating disease."
It is estimated that about 30% of postmenopausal women suffer symptoms of DES, which accounts for over 10 million women in the U.S. The majority of sufferers of DES are postmenopausal women; and clinical research around the world has suggested the benefits of both topical and systemic estrogen therapy in the treatment of DES in this population.
About Nascent Pharmaceuticals, Inc.
Nascent Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company. Nascent has acquired compounds and technologies in the areas ophthalmology and oncology that are in various stages of clinical and pre-clinical development. Nascent is currently seeking a co-development and commercialization partner for iDESTRIN. The company has offices in North Carolina and the San Francisco Bay Area. For more information, please visit our web site: www.nascentpharma.com.
Nascent Pharmaceuticals, Inc.CONTACT: Clive Reading, Chief Executive Officer of NascentPharmaceuticals, Inc., +1-919-967-1998, or readingc@nascentpharma.com
Web site: http://www.nascentpharma.com/
