Napo Pharmaceuticals, Inc. Announces Successful Clinical Results in Phase 2 Study of Crofelemer in Acute Adult Infectious Diarrhea
The conclusions from the study were that treatment with crofelemer was well tolerated and resulted in statistically significant improvements in all the primary endpoints and statistically significant reduction in the additional endpoints as well. Overall clinical success was achieved in 79.1% of the evaluable patients receiving crofelemer compared to 28.2% of the evaluable patients receiving placebo.
There were no drug related adverse events associated with crofelemer.
The Phase 2 study was a randomized, parallel group, double-blind, placebo-controlled which enrolled 98 Indian adult male and female patients aged between 18 to 65 years with acute diarrhea defined as the occurrence of three or more unformed stools (soft or watery consistency) within the 24 hour period preceding entry into the study. Patients suffering from acute infectious diarrhea were dosed 250mg of crofelemer, QID (4 times per day) until recovery or for a maximum of three days. Details regarding the stool weight, stool frequency, stool consistency, duration of diarrhea, and other gastrointestinal symptoms were recorded by the investigators at baseline, and days 1, 2 and 3 of treatment. All patients had a scheduled follow-up visit 30 days after the end of the last dose.
In conclusion, adult Indian patients with infectious diarrhea treated with crofelemer showed a faster recovery with the first dose itself as observed by the reduction in stool weight, stool frequency and passage of formed stools. Crofelemer was well tolerated and most adverse events were mild to moderate in severity and not different from the placebo group. Furthermore, the adverse events disappeared with continued therapy and causality was not attributed to the treatment.
Glenmark is Napo's exclusive licensee for crofelemer in over 140 countries for the indications of CRO-HIV, CRO-ID and CRO-PED. Glenmark anticipates it will begin another dose-ranging trial for CRO-ID in 2008, investigating the opportunity to treat with lower doses and lower frequency of dosing.
In combination with previous success in treating infectious diarrhea in travelers in Mexico and Jamaica with crofelemer, Napo is investigating the regulatory pathway to file an NDA for acute infectious diarrhea treatment with crofelemer coincident with its on-going Phase 3 program in chronic diarrhea in people living with HIV/AIDS (CRO-HIV). Napo is targeting an NDA filing for CRO-HIV around the end of the year. Napo has exclusive worldwide rights to crofelemer in all western territories.
Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc, said, "Napo is extremely pleased to see the achievement of statistical significance in this trial and that once again, crofelemer's safety profile has been confirmed. The success of this study is a very important step for Glenmark in its goal to develop crofelemer for CRO-ID in its territories. For Napo, it represents a significant step toward the realization of royalties from sales of crofelemer by Glenmark in over 140 countries, and may address the devastating morbidity and mortality issues associated with the billions of episodes of diarrhea in developing countries with a novel anti-secretory mechanism of action."
Pravin Chaturvedi, PhD, President and Chief Scientific Officer of Napo added, "The effects of crofelemer in this study of secretory diarrhea caused by infectious pathogens provides additional support and confidence to the mechanistic rationale for treating diarrhea in patients with different causes. In conjunction with the on-going Phase 3 trial that Napo is conducting in chronic diarrhea in people living with HIV/AIDS, this Glenmark trial will provide a new pathway to a therapy for both acute and chronic secretory diarrhea. Glenmark expects to file for approval of crofelemer for the CRO-ID indication in India in 2009, and, in combination with Napo's NDA programs for crofelemer, the various approvals may allow for subsequent approvals in the multiple countries where Glenmark is a licensee."
For more information please contact:
Napo Pharmaceuticals, Inc. Lisa Conte, Chief Executive Officer (001) + 650 616 1902 Charles Thompson, Chief Financial Officer (001) + 650 616 1903
Buchanan Communications (44) + 020 7466 5000 Tim Anderson, Mary-Jane Johnson
About Napo Pharmaceuticals, Inc.
Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. Napo was founded in November 2001, and is based in California, USA with a subsidiary in Mumbai, India.
Napo's late-stage proprietary gastro-intestinal compound, crofelemer, is in various stages of clinical development for four distinct product indications, including a late-stage Phase 3 program:
-- CRO-HIV for AIDS diarrhea, Phase 3 -- CRO-IBS for diarrhea irritable bowel syndrome ("D-IBS"), Phase 2 -- CRO-ID for acute infectious diarrhea (including cholera), Phase 2 -- CRO-PED for pediatric diarrhea, Phase 1
The FDA has granted fast-track status to CRO-IBS and CRO-HIV.
Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Napo also plans to develop an early clinical stage product, NP-500, for the treatment of insulin resistant diseases of Type II diabetes and metabolic syndrome (Syndrome X; pre-diabetic syndrome). Napo also has a plant library of approximately 2,300 medicinal plants from tropical regions, and Napo has entered two screening relationship associated with this collection. Currently, products are based on the chemical and biological diversity derived from plants with medicinal properties, but future products may be in-licensed from other sources.
Napo has partnerships with Glenmark Pharmaceuticals Limited of India and AsiaPharm Group Ltd. of China. For more information please visit www.napopharma.com.
About Glenmark Pharmaceuticals Limited
Glenmark is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.] and metabolic disorders [Diabetes, Obesity, etc.]. The Company is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark's speciality business alone is guided to generate $306 million (US) in Net Sales in fiscal year 2008 and $352 million (US) in fiscal year 2009. Glenmark's first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211, undergoing Phase 2 clinical trials in Europe, has been outlicensed to Eli Lilly & company. Visit www.glenmarkpharma.com for further details.
Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Crofelemer is in various stages of clinical development for four distinct product indications, one in Phase 3, two in Phase 2 and one in Phase 1.
Crofelemer has been tested in trials involving approximately 1500 patients in double-blind placebo-controlled, mostly published trials of AIDS diarrhea, diarrhea-predominant IBS, and acute infectious diarrhea. It is generally well tolerated and has shown significant anti-diarrheal activities and improvement in gastrointestinal symptoms. Crofelemer produces several effects when administered orally providing for activity in several disease indications. Crofelemer's anti-secretory mechanism reduces excess fluid secreted into the gastro-intestinal tract, while its anti-inflammatory and analgesic activity may provide the rationale for its significant benefit in abdominal pain. Crofelemer acts locally in the intestines, with limited systemic exposure.
Source: Napo Pharmaceuticals, Inc.