BNC-210

Bionomics BNC210 Expansion into Social Anxiety Disorder

Monday, May 10, 2021 - 11:00am

The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD.

Key Points: 
  • The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD.
  • A new solid dose tablet formulation of BNC210 has been successfully developed, showing much improved and rapid absorption over the previous liquid suspension formulation, and will be used for the Phase 2 efficacy clinical trials in SAD and PTSD.\n"Anxiety disorders are a significant burden for our communities and approximately 17 million American adults suffer from Social Anxiety Disorder.
  • Premier Research is recognised as a leading CRO supporting industry-sponsored PTSD studies and has conducted ~10 studies in this indication since 2014, including Bionomics\' RESTORE trial.
  • Collaborating again with Bionomics is the ideal way to leverage ourcollective experience in this space," said Krista Armstrong, PhD, Premier Research SVP, Clinical Development Services & Global Head of Neuroscience.

Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

Friday, April 30, 2021 - 5:00am

b'ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire) - Agilex Biolabs, Australia\'s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.\nLiz Doolin, Bionomics\' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning.

Key Points: 
  • b'ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire) - Agilex Biolabs, Australia\'s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.\nLiz Doolin, Bionomics\' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning.
  • "\nBionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical stage biopharmaceutical company.
  • Agilex Biolabs has been working closely with Bionomics for several years, supporting the PK regulated Bioanalysis of BNC210 and is privileged to be a part of this potential new treatment for anxiety and stressor-related disorders.
  • Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Positive BNC210 7-Day Dosing Pharmacokinetic Study Exceeds Blood Exposure Projected for Phase 2b PTSD Trial

Monday, February 22, 2021 - 11:00am

A pharmacometric analysis of data from the first Phase 2 PTSD trial (RESTORE) that read out in October 2018, modelled an exposure-response relationship between BNC210 blood levels and CAPS-5 scores (the primary endpoint measure in PTSD trials), and the potential for BNC210 to treat PTSD symptoms provided that adequate blood exposure could be achieved.

Key Points: 
  • A pharmacometric analysis of data from the first Phase 2 PTSD trial (RESTORE) that read out in October 2018, modelled an exposure-response relationship between BNC210 blood levels and CAPS-5 scores (the primary endpoint measure in PTSD trials), and the potential for BNC210 to treat PTSD symptoms provided that adequate blood exposure could be achieved.
  • The tablet formulation of BNC210 replaces the liquid suspension formulation used in RESTORE which did not provide sufficient blood exposure for efficacy in that Study.
  • The BNC210 tablet will be easier for the PTSD trial participants to administer and, unlike the liquid suspension formulation, is not dependent on food intake for maximal absorption and is therefore expected to result in substantially less variable exposure in the patients in the next Phase 2b PTSD study.
  • With the dose now selected, we can initiate manufacturing of the tablets, clinical site selection and regulatory filings in preparation for a Phase 2b trial with BNC210 in PTSD patients projected for mid-2021.

Joint feasibility assessment of Bionomics' BNC210 and EmpathBio's MDMA derivative EMP-01 treatment regimen for PTSD

Wednesday, February 17, 2021 - 11:00am

Under the Memorandum of Understanding, Bionomics and EmpathBio propose to collectively explore a combination drug treatment regimen with Bionomics' BNC210 and EmpathBio's 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01.

Key Points: 
  • Under the Memorandum of Understanding, Bionomics and EmpathBio propose to collectively explore a combination drug treatment regimen with Bionomics' BNC210 and EmpathBio's 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01.
  • The parties will explore whether the different mechanisms of action of EMP-01 and BNC210 may offer the potential for developing an improved treatment regimen for the treatment of Post-Traumatic Stress Disorder (PTSD).
  • BNC210 is Bionomics' lead drug candidate, which has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of PTSD and other trauma-related and stress-related disorders.
  • We consider that EMP-01, a derivative of MDMA, being developed by EmpathBio could be a very interesting treatment regimen when combined with BNC210 for the treatment of PTSD.

Novamind Announces Strategic Investment in Bionomics to Support PTSD Clinical Trial

Thursday, February 11, 2021 - 12:00pm

In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.

Key Points: 
  • In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.
  • Novamind's Strategic Investment is included in Bionomics' latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the "Bionomics Financing").
  • Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.
  • "I'm happy to welcome Novamind as a strategic investor in Bionomics," said Dr. Errol De Souza, Executive Chairman of Bionomics.

DGAP-News: Novamind Inc.: Novamind Announces Strategic Investment in Bionomics to Support PTSD Clinical Trial

Thursday, February 11, 2021 - 1:12pm

In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.

Key Points: 
  • In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.
  • Novamind's Strategic Investment is included in Bionomics' latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the "Bionomics Financing").
  • Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.
  • "I'm happy to welcome Novamind as a strategic investor in Bionomics," said Dr. Errol De Souza, Executive Chairman of Bionomics.

$16 Million Capital Raise to Progress Bionomics BNC210 PTSD Trial

Wednesday, February 10, 2021 - 11:00am

Bionomics' lead drug BNC210 has already received Fast Track Designation from the FDA and I am confident of the strong potential of the upcoming Phase 2b PTSD trial to drive value for both patients and shareholders."

Key Points: 
  • Bionomics' lead drug BNC210 has already received Fast Track Designation from the FDA and I am confident of the strong potential of the upcoming Phase 2b PTSD trial to drive value for both patients and shareholders."
  • Bionomics' lead drug candidate BNC210, currently in development for initiation of a second Phase 2 trial for the treatment of PTSD, is a novel, proprietary negative allosteric modulator of the alpha-7 (7) nicotinic acetylcholine receptor.
  • Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada).
  • Results of studies performed on our drug candidates and competitors' drugs and drug candidates may vary from those reported when tested in different settings.

Bionomics and MSD Scientists Publish Preclinical Findings for BNC375 in Peer-Reviewed Journal

Tuesday, March 31, 2020 - 11:00am

The paper entitled, Pharmacological characterization of the novel and selective 7 nicotinic acetylcholine receptor positive allosteric modulator BNC375, is authored by scientists from MSD and Bionomics Limited.

Key Points: 
  • The paper entitled, Pharmacological characterization of the novel and selective 7 nicotinic acetylcholine receptor positive allosteric modulator BNC375, is authored by scientists from MSD and Bionomics Limited.
  • The paper presents data from a comprehensive range of pre-clinical studies performed with BNC375 to explore the potential of this novel molecule to improve cognitive impairment.
  • Bionomics Executive Chairman, Dr Errol De Souza said, Data from our collaboration with MSD on BNC375 targeting cognitive impairment has been published in this peer-reviewed journal.
  • Beyond BNC210, Bionomics has a strategic partnership with MSD and a pipeline of pre-clinical ion channel programs targeting pain, depression, cognition and epilepsy.

Sale of Bionomics’ French Subsidiaries to Domain Therapeutics

Wednesday, December 11, 2019 - 11:00am

The sale price of 1,810,028.97 is the amount of intercompany debt owed by Bionomics to the subsidiaries for the scientific research conducted by them on Bionomics drug candidates and this debt will be assumed by Domain upon acquisition of the Companies.

Key Points: 
  • The sale price of 1,810,028.97 is the amount of intercompany debt owed by Bionomics to the subsidiaries for the scientific research conducted by them on Bionomics drug candidates and this debt will be assumed by Domain upon acquisition of the Companies.
  • We are pleased with the outcome of the sale of our French subsidiaries which is part of our ongoing cost reduction process, consolidation of our operations in Adelaide and focus on the clinical development of BNC210 for post-traumatic stress disorder, said Dr. Errol De Souza, Executive Chairman of Bionomics.
  • The offer from Domain is subject to satisfaction of a number of conditions precedent, including entering into definitive contractual documentation satisfactory to both parties and regulatory approval.
  • Bionomics lead drug candidate BNC210 is a novel, proprietary negative allosteric modulator of the alpha-7 (7) nicotinic acetylcholine receptor.

Bionomics Announces Fast Track Designation Granted by U.S. FDA to BNC210 Development Program for the Treatment of PTSD

Monday, November 4, 2019 - 11:00am

FDAs decision to grant Fast Track designation is an important recognition of the high unmet medical need in PTSD and potential benefits of BNC210 with a novel mechanism of action in the treatment of this disorder, said Dr. Errol De Souza, Executive Chairman of Bionomics.

Key Points: 
  • FDAs decision to grant Fast Track designation is an important recognition of the high unmet medical need in PTSD and potential benefits of BNC210 with a novel mechanism of action in the treatment of this disorder, said Dr. Errol De Souza, Executive Chairman of Bionomics.
  • We look forward to taking advantage of the Fast Track designation and working closely with FDA in the design and initiation of the next Phase 2b study in PTSD patients.
  • Fast Track designation is a FDA program intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.
  • Bionomics lead drug candidate BNC210 is a novel, proprietary negative allosteric modulator of the alpha-7 (7) nicotinic acetylcholine receptor.