19 August 2019
New interim results confirm the findings of February this year
Lactate Ring (an Intravaginal Drug-Delivery System with Sustained DL-Lactic Acid Release) is a vaginal ring matrix system consisting of a mixture of ethylene vinyl acetate and methacrylic acid-methyl methacrylate copolymer loaded with 150 mg DL-lactic acid with an L/D-lactic acid ratio of 1:1. It is under development by Aicore Life Sciences in cooperation with Ghent University. This intravaginal device provides the sustained vaginal DL-lactic acid enrichment, which according to our hypothesis would enhance the recruitment of lactobacilli, while counteracting bacteria associated with bacterial vaginosis. Lactate Ring is world-wide protected by a number of patents.
The Proof of Concept single-center Study to define the safety and preliminary efficacy of lactate Ring was started in September 2018. The Lactate Ring has been investigating in 3 arms of women - treated with metronidazole, Lactate Ring, or a combination of both. The Lactate Ring remained in the vagina during 21 consecutive days and was then removed.
An interim analysis based on results of 60% of enrolled patients was provided in July 2019.
No side effects were found in any of the women treated with the lactate ring. Compliance was very high and no negative effects were reported during daily and sexual activities. Efficacy in the prevention of recurrence of bacterial vaginosis seems comparable to metronidazole:
• There are preliminary indications that Lactate Ring may be efficacious as monotherapy and similar to Metronidazole (pronounced and lasting effect)
• 80% of women reported a rapid and sustained relief from complaints
• Lactate Ring demonstrates an excellent safety profile
• Patient acceptability was very high
• Lactate Ring is defined as a promising product worth further developing
• More comprehensive study is planned for both regulatory and scientific purposes
Aicore Life Sciences is now ready for distribution and/or co-development discussions with potential partners.