Anticipation for Positive FDA Developments Continues to Build for this Emerging Biotech Company.
Leading drug candidate BNC210 could turn Bionomics Limited (NASDAQ: BNOX) into the next biotech darling!
STRONG BUY
NASDAQ currently has a “STRONG BUY” rating on BNOX with several prominent analysts covering it.
This includes Cantor Fitzgerald and H C Wainwright!
Biotech offers the possibility of improving and making more sustainable human health. This is an arena that is anticipated to revolutionize the future of healthcare.
One category of health that needs more awareness is mental health. Global biotech giants including Biogen Inc. and Sage Therapeutics are chugging away at creating treatments that could help mental health disorders.
BNOX has a lead candidate that targets two common mental health disorders that affect millions of people:
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Post Traumatic Stress Disorder (PTSD)
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Social Anxiety Disorder (SAD)
Lead candidate BNC210 may be an absolute game-changer in addressing these two conditions and could aid in catapulting BNOX to Wall Street stardom.
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Company
Overview
BNOX is Targeting Common Neuropsychiatric Disorders of High Unmet Need.
The company is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD).
Utilizing the company’s deep expertise in ion channel biology and translational medicine, it designs best-in-class oral, small molecules to modulate ion channel function, influence neurotransmission, and consequently downstream signaling in the brain.
The company is currently focused on its proprietary allosteric modulators.
Negative allosteric modulators (“NAMs”) of the α7 receptor are developed for the treatment of anxiety and stressor-related disorders and Positive allosteric modulators (“PAMs”) are developed for the treatment of cognitive dysfunction.
BNC210: A Phase-3 Ready a7 Nicotinic Receptor Negative Allosteric Modulator Leads the Company Pipeline!
As a negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor (α7 nAChR), BNC210 has a unique and differentiated mechanism of action and extensive nonclinical and clinical studies have shown it has several properties which may be useful to treat SAD, PTSD and neuropsychiatric disorders.
In clinical studies, BNC210 has exhibited anti-panic properties by reducing the number and intensity of panic symptoms in a human model of panic disorder. In patients with Generalized Anxiety Disorder (GAD), BNC210 has demonstrated anti-anxiety activity in behavioral and on-anxiety scale scores (STAI).
Using functional magnetic resonance imaging (fMRI), BNC210 was shown to reduce hyperactivity in the amygdala of the brain, a region where increased activity is associated with anxiety.
Highlights:
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Holds the potential to address the shortcomings of existing therapies.
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Significant need for improved therapeutics for SAD and PTSD, with superior efficacy, response rates, fewer side effects, and a faster onset of actions.
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Demonstrated a well-tolerated safety profile and no food effect, indicating additional potential advantage over the current standard of care for SAD, PTSD, and other anxiety disorders (e.g. antidepressants, benzodiazepines).
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Non-sedating anxiolytic profile and rapid onset of action: potential first & and best-in-class for the acute treatment of Social Anxiety Disorder.
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If approved, could be the FIRST acute, as-needed treatment for Social Anxiety Disorder with a non-sedating, non-habit-forming profile.
Fast Track Designation!
The Food and Drug Administration (FDA) has granted a Fast Track designation to BNC210 for the treatment of patients with PTSD and SAD.
Fast track designation is designed to aid in the development and expedite the review of drugs that show promise in treating a serious or life-threatening disease and address an unmet medical need.
A Fast Track designation has provided BNOX an advantage that includes additional market exclusivity and expedited regulatory paths!
“We continue our strong momentum with our fast track designated BNC210, with a robust clinical and regulatory milestone-rich year in both SAD and PTSD, two highly prevalent neuropsychiatric disorders with significant unmet needs.”
Spyros Papapetropoulos
M.D., Ph.D., President and CEO of Bionomics
A CEO with the Know-How…
CEO Spyros Papapetropoulos is an experienced biopharmaceutical executive, a recognized neuroscientist/neurologist, and change agent with a 25-year career focused on CNS disorders.
He held various positions of increasing responsibility at CNS-focused start-up/small, medium specialty and large biopharma companies.
Since 2020, he has been the Chief Medical Officer of Vigil Neuroscience Inc, a Nasdaq-listed biopharmaceutical company developing a pipeline of neuroimmune targeted therapeutics for the treatment of neurodegenerative disorders.
Prior to joining Vigil, he served as Chief Development Officer, and SVP, Head of Development at Acadia Pharmaceuticals Inc., CEO at SwanBio Therapeutics, and EVP of Research & Development and Chief Medical Officer at Cavion.
Before Cavion, he held senior/executive positions at Biogen Inc., Allergan plc, Pfizer Inc., and Teva Pharmaceuticals Inc. Spyros has filed multiple INDs and has overseen a broad spectrum of CNS biopharmaceutical development programs (small molecules, biologics, gene therapy), leading to successful regulatory filings (>20 INDs and multiple NDAs/BLAs) and new product launches worldwide.
Spyros received his MD and PhD in Greece from the University of Patras, School of Medicine and before joining the biopharmaceutical industry served as faculty at the Department of Neurology of the University of Miami, School of Medicine.
Two Pivotal Studies:
The PREVAIL Study
BNOX has completed evaluating BNC210 in a phase II PREVAIL study for SAD.
The data from the study was promising and showed that both 225-mg and 675-mg doses of BNC210 resulted in a decline in anxiety across multiple phases of the public speaking challenge. Patients who received BNC210 experienced significantly less anxiety during the public speaking task (combined resting, anticipation and performance phases) compared to placebo.
The development of the phase III study and its data will potentially support the submission of a new drug application for BNC210 for the treatment of SAD.
BNOX plans to meet the FDA in September of 2023 to discuss the clinical requirements for advancing BNC210 into phase III development, based on data of PREVAIL study.
The company is confident that the results from the phase II PREVAIL study will support this progression!
The ATTUNE Study
The company’s phase IIb ATTUNE study is evaluating lead candidate BNC210 as a monotherapy for PTSD. Data from that study is expected in September of 2023.
The primary endpoint of the study is to evaluate the change in symptom severity score measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) compared to placebo.
Two Highly Addressable Markets:
How common is PTSD?
According to recent estimates, about 8 million adults in the United States alone have PTSD in any given year. This means that approximately 3.5% of the US population is affected by PTSD annually.
Data may underestimate the true prevalence of PTSD, as many people may not seek treatment or be properly diagnosed.
In addition, certain groups, such as those who experience chronic trauma or live in high-conflict areas, may be at even higher risk for developing PTSD. Despite its prevalence, there is still much work to be done to increase awareness and provide effective treatment for those with this debilitating condition.
How common is SAD?
Social anxiety disorder (formerly social phobia) is characterized by persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. The individual fears that he or she will act in a way (or show anxiety symptoms) that will be embarrassing and humiliating.
Social anxiety disorder is the third most common mental disorder, affecting upwards 5-12% of the general population at some point in life.
TOP REASONS TO PAY CLOSE ATTENTION TO BNOX RIGHT NOW:
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1BNC-210 is under clinical development by Bionomics and is currently in Phase II for Anxiety Disorders. According to GlobalData, Phase II drugs for anxiety disorders have a 35% phase transition success rate (PTSR) indication benchmark for progressing into Phase III.
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2The company is currently preparing for a U.S. Food and Drug Administration (FDA) End of Phase 2 (EoPh2) meeting to discuss the registrational program for BNC210 in SAD.
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3Start-up activities for a planned Phase 3 trial of BNC210 in SAD are underway. Contingent upon advice received by the FDA, the company is planning to initiate dosing in the Phase 3 study in SAD during the Quarter ending 31 March 2024.
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4In addition, the company continued over-seeing its recurring Independent Safety Review Committee meetings in the ongoing Phase 2b ATTUNE study of BNC210 in PTSD which completed enrollment and remains on track for topline data readout expected by the end of September.
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5Beyond BNC210, the company also has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions.
A Merck/MSD Partnership….
Merck/MSD α7 receptor PAM Collaboration
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In June 2014 Bionomics entered into in 2014 to develop α7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer’s disease and other central nervous system conditions.
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Merck funds all R&D activities including clinical development and worldwide commercialization of any products from collaboration.
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Payments received: US$20M upfront and US$10M for Phase 1 milestone.
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Eligible to receive up to US$465M in additional milestone payments plus royalties.
In summary…
The biotech space is known for companies scrambling to find game-changing and life-changing drugs and therapies for monstrous markets.
These are exciting times for Bionomics Limited (NASDAQ: BNOX) and the company’s news should be watched closely for any new developments on its lead candidate BNC210 which addresses TWO colossal markets.
BNOX could see Breakthrough Therapy designation for PTSD in the future, which is extremely noteworthy as no new therapy has been approved in about 20 years for PTSD.
The successful development and commercialization of BNC210 could boost BNOX’s prospects significantly and the company is firing on all cylinders to get towards commercialization!
Start your own research!
Download Research Report
Learn More about Bionomics Limited by gaining access to the latest research report