Evofem Biosciences Inc. (NASDAQ: EVFM) has signed a partnership agreement with Orion Biotechnology Canada Ltd to assess the stability and compatibility of Orion’s proprietary CCR5 antagonist, OB-002, in Phexxi vaginal gel to create a multipurpose prevention technology product for an indication that include HIV prevention in women. Phexii is a hormone-free vaginal gel contraceptive launched in 2020
No available products to simultaneously prevent HIV and pregnancy
Last year the World Health Organisation reported around 37.6 million people with HIV, with close to 1.5 million being individuals newly diagnosed as HIV+. Currently, there are limited methods of HIV transmission prevention with no approved products that can simultaneously prevent STIs, HIV, and pregnancy.
The partnership’s main focus will be establishing OB-002’s compatibility and stability in Phexxi, and the companies expect to yield results in Q3 2022. Should the study yield positive results, the companies will seek government approval and funding for clinical trials of the MPT vaginal gel product candidate.
The company’s CEO, Saundra Pelletier, stated, “For too long, women have had to assemble a grab-bag of products to protect against pregnancy, various STIs, and HIV. This partnership with Orion aims to develop a first-of-its-kind product with the potential to revolutionize the way women protect their sexual and reproductive health: no unintended pregnancies, no STIs, and no HIV — all in one applicator.”
The study shows vaginally administered OB-002 was 100% effective.
Orion Biotechnology Chief Medicals Officer Ian McGowan commented, “It is unacceptable that we are still seeing high rates of new HIV infections among women each year, and there is clearly a compelling need to expand the HIV prevention portfolio. Orion is very excited to be collaborating with Evofem to address this important issue and develop an MPT product for women across the world.”
Studies of OB-002 have shown best in class in-vitro strength, with the CCR5 antagonist showing 100% efficacy in blocking HIV infection transmission in the primate model. In addition, the Phase 1 study of vaginally given OB-002 showed that the gel was well tolerated and safe with no signs of systemic absorption.