I guess we need to see if resevior clearing is permanent with the combination of BIT225 and ART. From the 2018 'successful' results:
"In addition to the beneficial immunological effects, there was a significant reduction in the level of themacrophage activation marker sCD163 in the BIT225-treated population by the end of the treatment period.Higher levels of sCD163 are linked with worse clinical outcomes in patients. This reduction of sCD163 by BIT225 may provide additional clinical benefit in these patients.
The headline results indicate that BIT225 has had a profound effect on a source of virus that persists in thepresence of antiretroviral drugs.
Eradication of this virus, produced by long-lived reservoir cells, is centralto an eventual HIV cure strategy.Dr Michelle Miller, The Company’s Managing Director, explained: “This has been a complex trial. Goinginto it, we knew from laboratory-based studies that BIT225 targets and kills virus that hides in long-livedreservoir cells. The challenge was how to show this in humans. “No one has done this before, and there were no guidelines to follow. We have had to use a range oftechniques to show that BIT225 has done what we expected it to do i.e. clear out virus from these reservoirs.This has included the development and use of new cutting-edge assays, which has been a time-consumingprocess.
“When we designed this trial, we set up a range of different outcomes to look at. Some of the markers weset out to measure haven’t shown any differences, while others have shown very significant changes – andthese changes clearly indicate that BIT225 is having a unique and significant effect in these subjects.“One aspect we set out to measure was whether the addition of BIT225 could improve clearance of HIV-1from the blood. Current antiretroviral drugs are extremely efficient at rapidly clearing this virus, and thestudy confirms this. It was not surprising that no additional discernable reductions in blood virus levelswere seen with BIT225, but it was important to measure this. But we saw other significant differences thatclearly show BIT225 is doing something new and different to these current antiretroviral drugs.
“We know that antiretroviral drugs do NOT clear cellular reservoirs. HIV-infected people have to takedrugs for their lifetime to keep virus under control. This trial shows for the first time that there may be away to clear one of the main cellular reservoirs. This is a major step to the ultimate goal of curing HIV-1infection.” The trial was designed to assess the safety and antiviral activity of three month’s dosing of BIT225 incombination with antiretroviral drugs in treatment-naïve HIV-positive subjects. This was a double-blind,placebo-controlled study undertaken at trial sites in Thailand.
A total of 27 HIV-infected subjects, who hadnot previously taken any antiretroviral drugs, took once daily doses of 200 mg BIT225 or placebo for 12weeks in combination with antiretroviral drugs. At the end of 12 weeks, all continued to take antiretroviraldrugs as per standard protocols. A smaller cohort of 9 subjects took once daily doses of 100 mg BIT225 orplacebo; this cohort was set up for detailed pharmacokinetic profiling of the BIT225 and its interactionswith antiretroviral drugs.
BIT Price at posting:
3.6¢ Sentiment: Hold Disclosure: Held
(20min delay)