8:30 am Coffee and Morning Networking
9:00 am Chair’s Opening Remarks
9:10 am Substance Use Disorders as a Lifecycle Play for Neuropsychiatric Drugs
Synopsis
• How can we explore additional indications for Substance Use Disorders for drugs already in development for depression, schizophrenia, anxiety, insomnia, and the neuropsychiatric symptoms of Alzheimer’s Disease?
• Evaluating current approaches being developed for Stimulant (methamphetamine and cocaine) Use Disorder
9:35 am Trends in Substance Use Disorder Trials
Synopsis
• This presentation will address trends related to clinical trial design, definition of subject populations, identification of endpoints, and study execution.
• The development of new medications to treat substance use disorders, high priority within recent years.
• We will discuss both challenges and opportunities to improve the health and well-being of patients with SUDs through the development of new drug treatments.
10:00 am Development of CVL-231 for the Treatment of Psychosis
Synopsis
• CVL-231 was rationally designed as a positive allosteric modulator (PAM) that selectively targets the muscarinic acetylcholine 4 (M4) receptor subtype
• Harnessing the anti-psychotic benefit believed to be associated with M4 while minimizing the side effects typically associated with panmuscarinic agonists
• Phase 1b data readout
• Plans to further evaluate the potential of CVL-231 to provide a significant medical advancement
10:25 am 1PCN-101 (R-ketamine) for Treatment Resistance Depression
Synopsis
• PCN-101 is being developed by Perception Neuroscience for TRD and other mood disorders
• A Phase 1 SAD study in HV was completed which demonstrated good tolerability and safety
• Thoughts on the potential for a wider therapeutic window will be discussed.
10:50 am Live Q&A
11:20 am Speed networking
Exploring New Treatment Paradigms to Support Schizophrenia Patients
11:50 am Development of SEP-363856, a TAAR1/5-HT1A Agonist for the Treatment of Schizophrenia
Synopsis
• Summary of the discovery of SEP-363856 and its novel non-D2 based mechanism of action for the treatment of schizophrenia
• Rationale for development of a non-D2 agent for the treatment of schizophrenia: importance and implications
• Overview of clinical trial data to date, and status update of our Phase 3 clinical development program
12:15 pm Translational Pharmacology & Biomarker Development of the Novel α7 nAChR Positive Allosteric Modulator BNC375
Synopsis
• α7 positive allosteric modulators (PAMs) exhibit superior efficacy and selectivity to α7 agonists
• BNC375 improves cognitive function in aged African green monkeys which manifest pathological and cognitive hallmarks of Alzheimer’s disease
• BNC375 enhances 13C enrichment in brain metabolites in rat and nonhuman primate cortex following 13C glucose infusion, a novel translation biomarker for the development of α7 PAMs
12:40 pm Translational Research in Neuropsychiatry: An Update From Ulysses Neuroscience Ltd.
Synopsis
• Relevant translational preclinical model of depression
• Translational plasma biomarkers from rodents to humans
• The importance of EEG as a translational neurophysiological biomarker
12:55 pm BXCL501: Targeting Alpha2-Adrenrgic Receptors for Neuropsychiatric Symptoms
Synopsis
• Stress activates Noradrenergic Signaling and may precipitate psychiatric symptoms
• Alpha2-Adrenergic Receptors Regulate noradrenergic signaling
• BXCL501 is designed to activate alpha2-adrenergic receptors and thereby alleviate the symptoms caused by overactive noradrenergic signaling
• BXCL501 rapidly and effectively reduced agitation in patients with schizophrenia or bipolar disorder
1:20 pm Live Q&A
1:35 pm Lunch Break and Networking
Shaking up Psychiatry – Dismantling Barriers to Clinical Psychedelic Research. Discovering, Developing & Implementing Psychedelic Inspired Medicines Through Clinical Trials
2:35 pm Exploring Atai’s Unique Strategy: A Model for Innovation & Growth
Synopsis
• The platform model: How does it streamline growth within a company?
• A holistic approach: diving into the various approaches being developed across our assets including psychedelics, non-psychedelics, and artificial intelligence-driven drug discovery, BCI, DTx, precision psychiatry.
• Why is this particularly important for mental health?
• The intersection of technology and psychedelics: What role will digital technologies play in psychedelic-assisted therapy?
3:00 pm MDMA-Assisted Therapy: With One Successful Phase 3 Study, Is FDA Approval on the Horizon?
Synopsis
• Brief overview of where we are with current research and introducing the basic model of treatment, how it works and defining the path forward
• How do we navigate movement from public enthusiasm and newly positive clinical data to a delivery model that is broadly helpful?
• Evaluating our Phase 3 results
• Victories with the FDA post approval regulation, how can we make these therapies more palatable to the regulatory authorities?
• Risk evaluation mitigation strategies for post approval regulation
• Financial projection, what does the sales market look like?
• What is the income potential from data exclusivity?
• Further research and collaborations and the future vision of psychedelic assisted treatment centers worldwide
3:25 pm Clinical & Regulatory Challenges in Developing Psychedelics as Therapeutics
Synopsis
- Designing clinical trials that meet regulatory requirements without inadvertently stifling market access
- Managing the impact of CSA schedule 1 status during development
- Building an optimal case for appropriate down-scheduling post-approval
3:40 pm Live Q&A
3:55 pm Networking and Coffee Break
4:30 pm AI-driven Phenotypic Drug Discovery for CNS Indications
Synopsis
• The majority of first-in-class drugs used to treat psychiatric disorders
were discovered by their phenotypic effects
• PsychoGenics has industrialised AI-driven phenotypic drug discovery in
mice with our SmartCube system
• SmartCube has been integral in identifying clinical candidates for a
range of psychiatric disorders
4:45 pm Translational Research to Raise the Bar for the Development of Psychedelic-Based Medicines
Synopsis
• Evaluating the receptors that we are targeting at Psilera and our approaches to repurposing psychoactive natural products as building blocks for next generation therapies to improve mental health • Targeting patient-friendly, non-invasive delivery forms for psychedelics with poor oral bioavailability
• Assessing serotonin receptor activation of psychedelic drugs and novel analogues to accelerate and further validate our drug pipeline