OTTAWA, Oct. 31, 2018 (GLOBE NEWSWIRE) — Orion Biotechnology Canada Ltd., a developer of novel medical treatments, announced today the completion of a scientific advice meeting with the Medicines and Healthcare products Regulatory Agency (MHRA), UK, regarding the company’s innovative microbicide candidate OB-002H. This follows on from a previous Pre-IND interaction with the United States Food and Drug Administration.
Despite the increased uptake of Pre-Exposure Prophylaxis (PrEP) with oral Truvada, we are still seeing unacceptable levels of new HIV infections and it is clear that the HIV prevention field needs additional options including topical products. Designed to prevent the transmission of HIV, OB-002H gel has the potential to address an urgent and growing need for an HIV prevention product that is affordable, appealing to use, and easily integrates into the lifestyles of people at risk for HIV infection regardless of age, sex or gender.
Dr. Ian McGowan, Chief Scientific Officer of Orion Biotechnology, said, “We were very pleased to have had this dialogue with the MHRA. It confirmed that our pre-clinical program includes all the studies and data needed to complete our clinical trial application (CTA), and that our clinical study design was appropriate and met MHRA requirements. This is an important step in completing preparations for our CTA submission and bringing our novel microbicide to the clinical phase of testing which will take place in Poland. We look forward to receiving feedback from the Polish National Regulatory authority about our Phase 1 study.”
“The meeting with the MHRA was a very important step for the Company as it provided us with a clear endorsement that our preclinical and clinical programs were in line with MHRA expectations for the conduct of microbicide development. It also gives us confidence that the CTA we submit in Poland should be acceptable to the Polish National Regulatory Authority and allow us to enter the clinic with minimal delay,” commented Mark Groper, President and CEO of Orion. “Following this informative meeting with the MHRA, we can confirm that we are on track to evaluate OB-002H in a clinical trial for both men and women that should begin in Q2 2019.”