Bionomics Limited BNOX, a clinical-stage Australian biotechnology company, announced positive top-line results from its mid-stage study of BNC210 for the treatment of Post-Traumatic Stress Disorder (PTSD).BNC210 is Bionomics’ negative allosteric modulator of the α7 nicotinic acetylcholine receptor (nAChR), which is currently being evaluated in separate mid-stage studies for the treatment of Social Anxiety Disorder (SAD) and PTSD.The phase IIb ATTUNE study met its primary endpoint of a change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scorefrom baseline to week 12. Furthermore, the company also reported that a statistically significant change in CAPS-5 score was also observed at week four and week eight.The mid-stage study also met two of the secondary endpoints of the study with statistical significance, observing improvement in both clinician-administered and patient self-reporting. At week 12, treatment with BNC210 led to significant improvements in depressive symptoms and sleep as measured by the Montgomery-Åsberg Depression Rating Scale and Insomnia Severity Index, respectively.
The stock of the company skyrocketed about 243.8% on Thursday, in response to the encouraging news. Year to date, shares of BNOX have lost 27.6% compared with the industry’s 16.1% fall.Zacks Investment ResearchImage Source: Zacks Investment ResearchAlthough not achieved, BNC210 showed positive responses across other secondary endpoints of the ATTUNE study, including the clinician and patient global impression — symptom severity and the Sheehan Disability Scale. The ATTUNE study enrolled 212 patients in the United States and U.K., who were equally divided into two cohorts, receiving either twice daily 900 mg BNC210 as a monotherapy or placebo for 12 weeks.The twice-daily BNC210 900 mg had a favorable safety profile and was overall well tolerated. Reported adverse events were mostly mild-to-moderate in severity.Bionomics is gearing up to hold discussions with the FDA regarding the positive results from the phase IIb ATTUNE study to reach alignment with the regulatory body on the registrational path of BNC210 in PTSD.Earlier this year, the company announced the full results from its phase II PREVAIL study to evaluate the efficacy and safety of two BNC210 doses (225 mg and 675 mg) for the acute treatment of SAD. Per the study results, treatment with both doses of BNC210 resulted in reductions in anxiety across multiple phases of the public speaking challenge.
The candidate also demonstrated a favorable safety and tolerability profile.Bionomics has reportedly completed its phase III-enabling End-of-phase II meeting with the FDA to advance BNC210 into registrational studies in the SAD indication.
The company also has an ongoing collaboration with Merck MRK. Notably, MRK is developing a new candidate, MK-4334, which is derived from Bionomics’ original α7 nAChR positive allosteric modulator (PAM) candidate, BNC375.Bionomics and Merck entered into an exclusive collaboration and license agreement in 2014 to develop investigational candidates utilizing BNOX’s α7 nAChR PAM mechanism of action. Per the agreement, MRK is liable to fund all research and clinical development and worldwide commercialization of any resulting products.BNOX, so far, has received $20 million from Merck as an upfront payment for the agreement and $10 million upon achieving a phase I milestone. Bionomics is further eligible to receive up
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