FORT COLLINS, Colo. – April 4, 2012 – Ventria Bioscience has announced the successful completion of a phase 2 clinical trial of its lead therapeutic candidate, VEN100. The study was conducted by a team of investigators from the Department of Epidemiology, Division of Infectious Diseases, and Division of Geriatric Medicine at Johns Hopkins University (Baltimore, Md.). The randomized, double-blind, placebo-controlled study tested the safety and tolerability of VEN100 and its ability to reduce the incidence of antibiotic-associated diarrhea (AAD) in high-risk patients. The results showed a 52 percent relative risk reduction (RRR) and a 47.9 percent absolute risk reduction (ARR) in the incidence of diarrhea in the placebo versus VEN100 treatment groups (92.3 vs. 44.4 percent, respectively; P = 0.023). Thus, patients treated with VEN100 concurrently with antibiotic treatment were at a significantly reduced risk of experiencing diarrhea compared to the participants in the control group (the odds ratio was 0.07 [95% CI, 0.001–0.97]). VEN100 was also found to be safe and well tolerated, with no observed adverse events in the study.
"The development of AAD presents serious health risks, especially for the 14 million patients currently taking antibiotics in U.S. hospitals and skilled nursing facilities," said William B. Greenough III M.D., professor in the Division of Geriatric Medicine at Johns Hopkins University and the senior author on the study. "AAD is a significant cause of morbidity and death in this population, and we are currently without preventive options. A safe, new prophylaxis and treatment for AAD – especially one like VEN100, which is orally delivered and based on naturally occurring proteins – could have an important positive impact on patient care."
AAD is a common adverse effect of broad-spectrum antibiotics, occurring in as many as 25 percent of patients taking these drugs. AAD can be mild in otherwise healthy adults but can become severe and life threatening in high-risk patients including elderly, immune-compromised, or otherwise vulnerable patient groups. While Clostridium difficile is a known etiologic agent for diarrhea, C difficile infection explains less than half of all AAD cases.
"Current medical strategies for treating AAD and C difficile involve administration of additional antibiotics," said study author Michele Bellantoni, M.D., clinical director, Division of Geriatric Medicine and Gerontology at Johns Hopkins University. "These are not always effective and may contribute to the increase in antibiotic-resistant pathogens in health care settings. The results of our study suggest that VEN100, which contains recombinant human lactoferrin, may represent an interesting alternative approach to preventing and, perhaps, treating AAD."
VEN100 is a product under development to reduce risk of AAD in high-risk patients taking antibiotics. Its active ingredient is recombinant human lactoferrin, an iron-binding glycoprotein first identified in human breast milk as a protein product of mammary epithelial cells. Endogenous lactoferrin is believed to promote healthy establishment of the infant gastrointestinal system and has multiple anti-inflammatory and antimicrobial properties believed to contribute to this effect. The recombinant form, VEN100, is produced by Ventria using its proprietary ExpressTec biomanufacturing platform. In a previous study, Ventria's recombinant human lactoferrin was shown to reduce the duration of diarrhea in children when combined with another breast milk protein.
"The completion of this trial, along with the results of prior early-stage clinical efficacy and preclinical safety studies, paves the way for us to begin our pivotal phase 3 trial," said Scott Deeter, chief executive officer at Ventria Bioscience. "These trials also provide important validation of our method for producing highly pure, therapeutically active recombinant proteins in a cost-effective manner, with high production yields that can reduce the current economic barriers to their routine use."
The results of the phase 2 study were published in the Journal of Health, Population and Nutrition.* Thirty patients were enrolled in the randomized, double-blind, placebo-controlled study, testing eight weeks of human recombinant lactoferrin compared to the placebo for the prevention of AAD in long-term care patients.
*Complete reference: Laffan AM, McKenzie R, Forti J, Conklin D, Marcinko R, Shrestha R, Bellantoni M, Greenough WB. Lactoferrin for the prevention of post-antibiotic diarrhoea. J Health Popul Nutr. 2011;29(6):547-551.
Ventria Bioscience develops, manufactures and markets biotherapeutics and products used in bioprocessing, regenerative medicine, cell culture media, and research and development. Ventria's patented ExpressTec biomanufacturing technology enables the development of new and cost-effective biologic products.