Biotron jumps after Phase 2 trial success

Biotron (ASX:BIT) jumped +15% this morning after announcing promising results from its BIT225-011 Phase 2 clinical trial, indicating that the primary objectives of the study have been achieved.

This trial focused on evaluating BIT225, the company’s lead antiviral drug, in combination with standard antiretroviral therapy (cART), for HIV-1 infected individuals who had achieved only partial immune reconstitution.

The trial, involving 20 treatment-experienced participants, assessed BIT225’s safety, tolerability, and its impact on immune activation, inflammation, and viral markers over a 12-week period.

Preliminary analysis revealed that BIT225 at a daily dose of 200mg was generally safe and well tolerated, with no drug-related serious adverse events reported.

Although one participant withdrew from the study after the initial dose, adverse events were mild and consistent with previous trials.

Regarding efficacy, the study observed maintained viral suppression throughout the treatment period. Significant changes (P<0.05) were noted in immune markers such as NK cells and T-regulatory cells, crucial in combating viral infections.

These findings suggest that BIT225, when used alongside cART, may have an immune-modifying effect beneficial to HIV-1 patients who exhibit incomplete immune recovery post-antiviral therapy.

Professor Anthony Kelleher from the Kirby Institute at the University of NSW said the results were very positive and significant, noting that individuals who do not fully restore their immune function post-antiviral therapy face increased risks of serious health conditions.

“These individuals are at enhanced risk for serious comorbid conditions including neurocognitive, cardiovascular, renal and hepatic disorders that impair quality of life and drive healthcare expenditures.”

While the trial did not show an increase in CD4 cells, which are critical for immune function, the observed changes in immune markers are promising and warrant further clinical investigation, says Biotron.

Michelle Miller, Biotron’s CEO, added: “This trial extends our understanding of BIT225 and complements the results from the previous HIV trials.

“The results reported here are preliminary, and ongoing analysis of this BIT225-011 trial and the BIT225-010 HIV-1 trial in a treatment-naïve population will be reported when complete.”


Mach7 renews US contract worth $1.9m

Meanwhile, Mach7 Technologies (ASX:M7T) has just announced a significant milestone with the renewal of a 3-year subscription agreement valued at $1.9 million with DocPanel for its Enterprise Imaging Platform and eUnity Diagnostic Viewer.

DocPanel serves as the largest radiology marketplace in the US, connecting imaging providers and patients with a network of over 600 academic and subspecialty radiologists.

The deal, effective from April 1, is expected to generate approximately $0.6 million in Annual Recurring Revenue (ARR) for Mach7.

This represents a substantial increase of $0.5 million in ARR compared to the previous contract, with potential for further growth based on volume performance beyond minimum thresholds.

Mike Lampron, CEO of Mach7 said this renewal deal is a pivotal achievement, marking the culmination of the company’s largest renewal program to date.

The Enterprise Imaging Platform was designed to streamline and manage medical imaging data across healthcare organisations.

The eUnity Diagnostic Viewer meanwhile is medical imaging viewer that enables healthcare professionals to view and interpret medical images from any location using a standard web browser.