Biotron updates on BIT225-009 development

Latest News

Australian company Biotron (ASX:BIT) has updated shareholders following the release of positive outcomes from the BIT225-009 phase 2 HIV-1 clinical trial.

It said the trial was the first time BIT225 was tested in HIV-infected people over an extended period (12 weeks of dosing).

"This means that we were able to measure different responses than can be analysed in shorter trials and identify specific effects in humans that cannot be discerned from cell culture or animal studies," said the company.

Biotron said it is "encouraged" by the results of the HIV-1trial is because it indicate BIT225 induces a desired immune response.

"This effect is additional to the targeting by BIT225 of virus in macrophage cells. These cells remain one of the key reservoirs of infection even in the presence of current approved anti-HIV-1 drugs. Together, these two effects of BIT225 have the potential to be key steps towards the ultimate goal of eradicating HIV-1 virus," it said.

The company said it has been working on understanding how treatment with BIT225 has generated this immune response.

"We have had a strong rationale of how BIT225 induces these changes and to prove this we have been testing samples of blood collected during the trial for a range of different markers. The levels of these markers allow us to determine precisely how BIT225 treatment has impacted on specific immune pathways," it said.

"This testing of blood samples is proceeding well and providing key information that is helping us to understand the mechanism behind the results observed in the 009 clinical trial. The results are showing us, and importantly, potential partners, how BIT225 works and how it can be used to eradicate HIV."

Biotron said it will shortly hold a scientific/clinical advisory meeting with internationally recognised HIV-1 experts.

"The participants have extensive expertise in clinical development of HIV-1 treatments, as well as experience in advising the pharma industry. The aim is to map out the next stage of clinical development based on the latest data. During the second half of 2019, we are planning to consult with the USA Food and Drug Administration (FDA) to ensure the proposed path is in accordance with relevant regulations," it said.

"The positive outcomes from the 009 trial also mean that Biotron has been meeting with key potential partners with compelling Phase 2 data in hand," it added.

The company also updated on its hepatitis B program.

"Biotron has designed a portfolio of small molecule drugs that effectively work against HBV in cell cultures. While early, the data are encouraging. We are working with a US-based research group to further characterise the anti-HBV activity of Biotron’s compounds," it said.