On December 16, 2021 Evofem Biosciences, Inc. (NASDAQ: EVFM) and Orion Biotechnology Canada Ltd. reported that they have entered into a collaboration agreement to evaluate the compatibility and stability of Orion’s novel CCR5 antagonist, OB-002, in Evofem’s Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel with the goal of developing a Multipurpose Prevention Technology (MPT) product candidate for indications including the prevention of HIV in women (Press release, Orion Biotechnology, DEC 16, 2021, View Source [SID1234597407]).
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The World Health Organization reported in 2020 that approximately 37.6 million people globally were living with HIV and an estimated 1.5 million individuals were newly diagnosed as HIV-positive. There are limited methods available to prevent transmission of HIV, and no products are approved to simultaneously prevent pregnancy, STIs and HIV.
This collaboration will focus on determining compatibility and stability of OB-002 in Phexxi and is expected to yield results in the third quarter of 2022. Assuming positive results, the companies will seek government and philanthropic funding for subsequent clinical trials of the MPT vaginal gel product candidate.
"For too long, women have had to assemble a grab-bag of products to protect against pregnancy, various STIs, and HIV," said Saundra Pelletier, Chief Executive Officer of Evofem Biosciences. "This partnership with Orion aims to develop a first-of-its-kind product with potential to revolutionize the way women protect their sexual and reproductive health: no unintended pregnancies, no STIs, and no HIV — all in one applicator."
Ian McGowan, Chief Medical Officer of Orion Biotechnology, added, "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."
In trials to date of Orion’s novel CCR5 antagonist, OB-002 has demonstrated best-in-class in vitro potency. OB-002 was 100% effective in blocking transmission of HIV infection in a non-human primate model.1 A 15-subject Phase 1 study of vaginally administered OB-002 gel demonstrated that the OB-002 gel was safe and well tolerated, with no evidence of systemic absorption.2
Phexxi is a hormone-free, on-demand prescription contraceptive vaginal gel that was launched in the U.S. in September 2020. Top-line data is expected from Evofem’s pivotal Phase 3 trial for the prevention of chlamydia and gonorrhea in women in the second half of 2022.
1 Veazey et al. Topical OB-002 is highly effective in preventing vaginal transmission of SHIV1623P in a non-human primate (NHP) model of HIV infection. JID, 2009.
2 McGowan et al. Evaluation of the Safety, Acceptability, and Pharmacokinetic Profile of a Gel Formulation of OB-002 in Healthy Volunteers. AIDS Res Hum Retroviruses, 2021.