Health: Bionomics looks to get ‘back on track’ as it switches into the fast lane for US approval
Health & Biotech
Health & Biotech
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Clinical-stage biopharmaceutical company Bionomics (ASX:BNO) just got some good news from US regulators.
The company has been experimenting with different formulations for its BNC210 development program, used in the treatment of Post-Traumatic Stress Disorder (PTSD).
And this morning, it announced that the US Food & Drug Administration (FDA) had granted BNC210 a Fast Track designation — a move which could help to expedite the approval process as Bionomics moves through clinical testing.
Shares in the company have struggled for traction this year amid a wavering outlook for BNC210’s effectiveness. But they jumped sharply in morning trade following the announcement:
Fast-Track designations are typically awarded by the FDA for treatments that have potential to be effective in a medical area that has a high unmet need.
Bionomics’ efforts to commercialise its drug treatment flatlined earlier this year, when it said testing on elderly patients showed no difference from a placebo.
But since then, the company has been developing a “novel dose formulation” which has proven effective enough to catch the eye of US health regulators.
“Preparations are underway for optimisation of the solid dose formulation, in anticipation of initiation of a phase 2b trial in PTSD patients,” Bionomics said.
Stockhead has contacted the company for details around expected timelines for the next stage of testing.
Bionomics executive chairman Dr Errol De Souza said further studies and testing around target blood levels had helped the company gets its BNC210 treatment “back on track” over the past year.
“We look forward to working closely with the FDA in the design and initiation of the phase 2b study in PTSD patients.”
Benefits associated with the fast-track process include increased access for meetings and written communication with the FDA, along with priority-review conditions if specific criteria are met.
Telix Pharmaceuticals (ASX:TLX) announced a Q3 clinical trial program update for its Molecularly Targeted Radiation (MTR) technology used in the precise imaging of cancerous cells. The company has six trials on the go for treatments across brain, prostate and renal cancer, two of which it expects to reach phase III status within the next 12 months. Shares in TLX ticked lower in morning trade to $1.57.
And Optiscan (ASX:OIL) has submitted a meeting request to the US Center for Devices and Radiological Health — a division of the FDA — to discuss its submission to enable the legal sale in the US of its Optiscan system, for both oral cancer screening and/or surgery. As it pushes towards commercialisation, Optiscan has clinical trials underway at hospitals in New York and Melbourne.