Health: Bionomics heading towards redo of failed PTSD trial, shares fly 81pc
Health & Biotech
Health & Biotech
Shares in Bionomics (ASX:BNO) have flown to their highest point since May as it looks redo the failed post traumatic stress disorder trial that wiped out 66 per cent of the company’s value last October.
Bionomics conducted a pharmacokinetic study in healthy volunteers using a newly-developed solid dose formulation of its lead drug candidate, BNC210, and found that the dose achieves the blood levels predicted as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in future clinical trials.
In October last year, the company announced that BNC210 had failed to provide sufficient blood exposure for efficacy in its phase II trial in patients with PTSD, which sent the share price plummeting and caused a back-room renovation.
But in February Bionomics revealed there was hope for the treatment after all because the original trial included people who didn’t take the drug properly (with food).
Later analysis showed that among those who did take the drug correctly, it remained in the patients’ bloodstream and did have a positive effect on PTSD symptoms.
And there’s even better news — data suggests the newly-developed solid dose formulation of BNC210 can overcome the ‘food effect’ to give clinically meaningful and statistically significant changes from placebo on CAPS-5 (clinically administered PTSD scale) scores, a 30-item questionnaire used by clinicians to assess symptoms.
BNO shares rose as much as 81 per cent to 10.5c on the news. The company will now begin the process of redoing the clinical trial in patients with PTSD to see if it has an impact.
Read more:
Bionomics says its ‘failed’ PTSD drug might work after all, shares fly 75pc
Bionomics just announced a failed trial and its shares are in free fall
Bionomics is hoping bowel cancer will give them the win PTSD did not
Immutep (ASX:IMM) expands trial. Immutep has expanded the first part of its phase II clinical trial, testing its drug TACTI-002 in patients with non-small cell lung cancer, after receiving early positive interim data from trial assessors. A second cohort of 19 patients will be recruited into the trial.
ResApp (ASX:RAP) gets more approval. The company has received CE Mark certification for its ResAppDx-EU version 2, the latest version of its smartphone-based diagnostic test for respiratory disease which addresses both adults and children. This certification adds the ability to test adults for lower respiratory tract disease, pneumonia, asthma exacerbation and chronic obstructive pulmonary disease (COPD) exacerbation.
Starpharma (ASX:SPL) gets the green light. The US Food and Drug Administration has authorised the use of AstraZeneca’s DEP Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug application. This is the first DEP candidate to reach this milestone from Starpharma’s multi-product license with AstraZeneca.