Beckley Psytech Announces Partnership With Ksana Health, Building on Digital Strategy to Deliver Optimised Patient Outcomes

Beckley Psytech Announces Partnership With Ksana Health, Building on Digital Strategy to Deliver Optimised Patient Outcomes

  • Partnership will focus on the collection and analysis of digital biomarkers to identify signs of response and relapse in upcoming Phase 2 clinical trials
  • Beckley Psytech aims to track and improve patient experience through an integrated, digitally-assisted treatment model

June 14, 2022 02:00 AM Eastern Daylight Time

OXFORD, England–(BUSINESS WIRE)–Beckley Psytech Limited, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, and Ksana Health, a behavioural health company that uses technology to provide personalised insights and interventions to improve mental health care, today announced that the companies have entered into a partnership to support the collection and analysis of digital behavioural data in Beckley Psytech’s future clinical trials.

Beckley Psytech will use Ksana Health’s Effortless Assessment Research System (EARS), an end-to-end solution for mobile sensing, to collect passive mobile device meta data from clinical trial participant’s smartphones, in order to identify individual signals of potential response and relapse. By partnering with Ksana Health, Beckley Psytech aims to track novel, predictive digital biomarkers to follow patient progress in upcoming Phase 2 studies evaluating the use of 5-MeO-DMT in combination with psychotherapy in the treatment of treatment resistant depression (TRD).

This latest partnership further strengthens Beckley Psytech’s digital strategy to develop personalised, end-to-end treatment programmes for patients in areas of significant unmet medical need.

Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “This partnership with Ksana Health further supports our strategy to develop an integrated psychedelic treatment model, ensuring that patients are continuously supported throughout their treatment journey. We look forward to working with Ksana Health and exploring how their state-of-the-art digital technology can help support patient safety and response in our upcoming Phase 2 clinical trials.”

Dr. Nick Allen, co-founder and CEO of Ksana Health, commented: “Psychedelic treatments are offering exciting new approaches to recovery from mental disorders. However, we need rigorous clinical trials to ensure that this promise is realised. We are therefore very excited to partner with Beckley Psytech to help them build out their digital strategy. By using our continuous behavioural health measurement tools, we can help Beckley Psytech to understand each patient’s journey more deeply, which will ultimately allow for more effective and personalised treatments.”

-Ends-

About 5-MeO-DMT
5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychoactive compound which binds to a variety of receptors within the brain pertaining to serotonin. A psychedelic substance which occurs naturally in a number of plant species, as well as in the Sonoran Desert toad, studies have indicated that 5-MeO-DMT is associated with improvements in mood, anxiety, reduced stress, increased life satisfaction and mindfulness. 5-MeO-DMT has been reported to produce mystical experiences with comparative intensity as seen with high doses of psilocybin but has a significantly shorter duration of effect. Beckley Psytech is developing proprietary synthetic intranasal formulations of 5-MeO-DMT (BPL-002 and BPL-003) and plans to evaluate their potential therapeutic effects in patients suffering from Treatment Resistant Depression, as well as other Mood and Use Disorders indications.

Beckley Psytech – www.beckleypsytech.com
Beckley Psytech is a clinical stage privately held company dedicated to helping patients suffering from neurological and psychiatric disorders by developing a broad pipeline of psychedelic compounds in rare and more common diseases. Our vision is for clinically validated psychedelic medicines to be integrated into modern medical practice in order to help patients with high unmet medical need around the world suffering with treatment resistant depression, and other profoundly debilitating neurological conditions. Beckley Psytech was founded in 2019 leveraging some of the expertise developed over more than 20 years by the Beckley Foundation, an independent non-profit and world leader in psychedelic medicine research, and is based out of Oxford, United Kingdom.

Ksana Health – www.ksanahealth.comKsana Health was founded in 2019 in order to translate the tools and findings developed by the University of Oregon’s Center for Digital Mental Health into products and services that will transform mental health care and research. Led by Dr. Nick Allen, a Professor of Clinical Psychology with extensive research and clinical experience, and Will Shortt, an experienced software business leader and startup CEO, Ksana Health aims to give clients, practitioners, administrators, and researchers the digital tools that will define the future of mental health.

Contacts

Beckley Psytech
Cosmo Feilding Mellen
Chief Executive Officer
info@beckleypsytech.com

Communications
FTI Consulting
Ben Atwell / Mike Trace
+44 (0)20 3727 1000
beckleypsytech@fticonsulting.com

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
+41 76 735 01 31
gvanrenterghem@lifesciadvisors.com

Ksana Health
Will Shortt
+1 541-912-2883
will.shortt@ksanahealth.com

Beckley Psytech Announces Partnership With Empatica in Latest Step of Digital Strategy, Designed to Deliver Personalised Patient Care

Beckley Psytech Announces Partnership With Empatica in Latest Step of Digital Strategy, Designed to Deliver Personalised Patient Care

  • Partnership will capture behavioural and physiological signals and predictive biomarkers in Beckley Psytech’s upcoming Phase 2 clinical trials
  • New digital strategy aims to improve patient outcomes and safety by integrating advanced digital tools into the psychedelic treatment journey
EmbracePlus is a medical-grade wearable that enables the passive, remote monitoring of physiological and behavioural signals. Photo credit: Empatica

EmbracePlus is a medical-grade wearable that enables the passive, remote monitoring of physiological and behavioural signals. Photo credit: Empatica

May 19, 2022 02:00 AM Eastern Daylight Time

OXFORD, England–(BUSINESS WIRE)–Beckley Psytech Limited, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, and Empatica, Inc., a medical wearables and digital biomarker company offering continuous, passive, and unobtrusive monitoring for patients with neurological conditions, today announced that the companies have entered into a partnership to support the collection and analysis of behavioural and physiological data in Beckley Psytech’s future clinical trials.

This partnership will utilise Empatica’s medical-grade EmbracePlus wearable and software, to identify and measure passive behavioural and physiological signals in the upcoming Phase 2 studies evaluating the use of 5-MeO-DMT in combination with psychotherapy in the treatment of treatment resistant depression (TRD).

The strategic partnership with Empatica is the latest step in Beckley Psytech’s digital strategy to develop personalised treatment programmes for patients in need. The digital enhancement of the psychedelic treatment pathway aims to support patients before, during, and after treatment through the application of novel, predictive biomarkers which will potentially identify early signals of patient response and relapse.

Beckley Psytech aims to establish a complete, end-to-end personalised psychedelic treatment programme, combining advanced digital phenotyping capabilities, such as those developed by Empatica, with psychedelic-assisted psychotherapy. This will allow clinicians to provide patients with continuous access to personalised therapy support beyond their treatment, delivering potentially improved outcomes and safety for patients and healthcare systems.

Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “As we look to enhance the safety and effectiveness of our psychedelic treatments with patient-centric digital tools, this partnership with Empatica accelerates our strategy of creating an integrated treatment model to ensure patients are fully supported through the treatment journey. We are thrilled to be working with Empatica, a pioneering digital health company, through our upcoming clinical trials and look forward to further evolving our understanding of how digital tools can support and potentially improve outcomes for patients with neurological and psychiatric conditions.”

Matteo Lai, CEO of Empatica, commented: “We couldn’t be more excited to collaborate with Beckley Psytech on this important project, especially since over the past two years, we have witnessed how critical mental health and depression have become globally. The potential of psychedelic treatments in the field can help millions of patients, and Empatica is honored to contribute its technology in one of the world’s first trials with psychedelics and digital tools, to advance these novel therapies with targeted help and better engagement.”

About 5-MeO-DMT
5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychoactive compound which binds to a variety of receptors within the brain pertaining to serotonin. A psychedelic substance which occurs naturally in a number of plant species, as well as in the Sonoran Desert toad, studies have indicated that 5-MeO-DMT is associated with improvements in mood, anxiety, reduced stress, increased life satisfaction and mindfulness. 5-MeO-DMT has been reported to produce mystical experiences with comparative intensity as seen with high doses of psilocybin but has a significantly shorter duration of effect. Beckley Psytech is developing proprietary synthetic intranasal formulations of 5-MeO-DMT (BPL-002 and BPL-003) and plans to evaluate their potential therapeutic effects in patients suffering from Treatment Resistant Depression, as well as other Mood and Use Disorders indications.

Beckley Psytech – www.beckleypsytech.com
Beckley Psytech is a clinical stage privately held company dedicated to helping patients suffering from neurological and psychiatric disorders by developing a broad pipeline of psychedelic compounds in rare and more common diseases. Our vision is for clinically validated psychedelic medicines to be integrated into modern medical practice in order to help patients with high unmet medical need around the world suffering with treatment resistant depression, and other profoundly debilitating neurological conditions. Beckley Psytech was founded in 2019 leveraging some of the expertise developed over more than 20 years by the Beckley Foundation, an independent non-profit and world leader in psychedelic medicine research, and is based out of Oxford, United Kingdom.

Empatica – www.empatica.com
Empatica Inc is a pioneer in continuous, unobtrusive, and remote health monitoring driven by AI. Empatica’s platform combines accurate digital biomarkers, software and wearables to monitor multiple conditions. Empatica’s products are used by thousands of institutional partners for research purposes, in trials and studies examining Stress, Sleep, Epilepsy, Migraine, Depression, Addiction, and other conditions.

Contacts

Beckley Psytech
Cosmo Feilding Mellen
Chief Executive Officer
info@beckleypsytech.com

Communications
FTI Consulting
Ben Atwell / Mike Trace
+44 (0)20 3727 1000
beckleypsytech@fticonsulting.com

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
+41 76 735 01 31
gvanrenterghem@lifesciadvisors.com

Empatica
Marianna Xenophontos
Director of Marketing
mx@empatica.com

Beckley Psytech to Attend and Present at 8th Annual LSX World Congress 2022

Beckley Psytech to Attend and Present at 8th Annual LSX World Congress 2022

OXFORD, England–(BUSINESS WIRE)–Apr 13, 2022–

Beckley Psytech Limited, a UK private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, today announces that Cosmo Feilding Mellen, Chief Executive Officer, will attend the 8 th Annual LSX World Congress, taking place in London from 10 th to 11 th May 2022, and will hold a formal presentation in front of investors.

Company presentation details

  • Tuesday, 10 th May 2022, 10.30 am ET / 3.30 pm BST
  • Please register for the event here

A link to the presentation will be available on the Company’s website from 16 th May 2022.

The presentation will introduce Beckley Psytech, its target indications, pipeline of drugs and ongoing clinical trials:

  1. 5-MeO-DMT intranasal formulation safety and tolerability – Phase 1 dose ranging study, and
  2. low-dose psilocybin Phase 1b in SUNHA 1

To request a one-on-one meeting with the Beckley Psytech management team, please contact us at gvanrenterghem@lifesciadvisors.com.

-Ends-

Beckley Psytech – www.beckleypsytech.com

Beckley Psytech is a clinical stage privately held company dedicated to helping patients suffering from neurological and psychiatric disorders by developing a broad pipeline of psychedelic compounds in rare and more common diseases. Our vision is for clinically validated psychedelic medicines to be integrated into modern medical practice in order to help patients with high unmet medical need around the world, suffering from Short-lasting unilateral neuralgiform headache attacks (SUNHA), treatment resistant depression and other profoundly debilitating conditions. Beckley Psytech was founded in 2019 leveraging some of the expertise developed over more than 20 years by the Beckley Foundation, an independent non-profit and world leader in psychedelic medicine research, and is based out of Oxford, United Kingdom.

1 Short-lasting unilateral neuralgiform headache attacks

View source version on businesswire.com:https://www.businesswire.com/news/home/20220412005773/en/

CONTACT: Beckley Psytech

Cosmo Feilding Mellen

Chief Executive Officer

info@beckleypsytech.com

Communications

FTI Consulting

Ben Atwell / Mike Trace

+44 (0)20 3727 1000

beckleypsytech@fticonsulting.com

Investor Relations

LifeSci Advisors

Guillaume van Renterghem

+41 76 735 01 31

gvanrenterghem@lifesciadvisors.com

KEYWORD: UNITED KINGDOM EUROPE

INDUSTRY KEYWORD: BIOTECHNOLOGY MENTAL HEALTH HEALTH PHARMACEUTICAL CLINICAL TRIALS

SOURCE: Beckley Psytech Limited

Copyright Business Wire 2022.

PUB: 04/13/2022 02:00 AM/DISC: 04/13/2022 02:02 AM

http://www.businesswire.com/news/home/20220412005773/en

Beckley Psytech to Attend and Present at 8th Annual LSX World Congress 2022

Beckley Psytech to Attend and Present at 8th Annual LSX World Congress 2022

OXFORD, England–(BUSINESS WIRE)–Beckley Psytech Limited, a UK private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, today announces that Cosmo Feilding Mellen, Chief Executive Officer, will attend the 8th Annual LSX World Congress, taking place in London from 10th to 11th May 2022, and will hold a formal presentation in front of investors.

Company presentation details

  • Tuesday, 10th May 2022, 10.30 am ET / 3.30 pm BST
  • Please register for the event here

A link to the presentation will be available on the Company’s website from 16th May 2022.

The presentation will introduce Beckley Psytech, its target indications, pipeline of drugs and ongoing clinical trials:

  1. 5-MeO-DMT intranasal formulation safety and tolerability – Phase 1 dose ranging study, and
  2. low-dose psilocybin Phase 1b in SUNHA1

To request a one-on-one meeting with the Beckley Psytech management team, please contact us at gvanrenterghem@lifesciadvisors.com.

-Ends-

Beckley Psytech – www.beckleypsytech.com

Beckley Psytech is a clinical stage privately held company dedicated to helping patients suffering from neurological and psychiatric disorders by developing a broad pipeline of psychedelic compounds in rare and more common diseases. Our vision is for clinically validated psychedelic medicines to be integrated into modern medical practice in order to help patients with high unmet medical need around the world, suffering from Short-lasting unilateral neuralgiform headache attacks (SUNHA), treatment resistant depression and other profoundly debilitating conditions. Beckley Psytech was founded in 2019 leveraging some of the expertise developed over more than 20 years by the Beckley Foundation, an independent non-profit and world leader in psychedelic medicine research, and is based out of Oxford, United Kingdom.


1 Short-lasting unilateral neuralgiform headache attacks

Contacts

Beckley Psytech
Cosmo Feilding Mellen
Chief Executive Officer
info@beckleypsytech.com

Communications
FTI Consulting
Ben Atwell / Mike Trace
+44 (0)20 3727 1000
beckleypsytech@fticonsulting.com

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
+41 76 735 01 31
gvanrenterghem@lifesciadvisors.com

Beckley Psytech Announces Dosing of First Healthy Volunteers in Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of Second Innovative Formulation of 5-MeO-DMT

Beckley Psytech Announces Dosing of First Healthy Volunteers in Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of Second Innovative Formulation of 5-MeO-DMT

  • Study represents continued efforts to further understand the clinical and pharmacological potential of 5-MeO-DMT
  • BPL-003 is Beckley Psytech’s innovative dry powder intranasal formulation of 5-MeO-DMT using FDA approved intranasal delivery devices
  • Data from Phase 1 will be used to select lead compound for upcoming Phase 2 in treatment resistant depression (TRD)

April 05, 2022 02:00 AM Eastern Daylight Time

OXFORD, England–(BUSINESS WIRE)–Beckley Psytech, a private company dedicated to addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, announced that the first healthy volunteers have been dosed in a Phase 1 clinical trial exploring the safety and pharmacokinetics of BPL-003, Beckley Psytech’s second innovative formulation of 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT).

“We are committed to exploring the full therapeutic potential of psychedelic medicines. By looking to tailor the potential therapeutic effects of these compounds through dose and delivery mechanisms, such as FDA approved devices, we aim to optimise treatment outcomes and reduce the burden on the patient, healthcare systems and society.”Tweet this

The Phase 1 study is designed as a double-blind, randomised, single ascending dose study to evaluate the safety and pharmacokinetics of BPL-003 in psychedelic-naïve healthy subjects. The study will recruit up to 36 participants (dependent on response) in 6 cohorts of 6 healthy volunteers on increasing doses.

A separate Phase 1 study is ongoing, evaluating the safety and pharmacokinetics of BPL-002, a liquid intranasal formulation of 5-MeO-DMT.

While both BPL-002 and BPL-003 are formulations of 5-MeO-DMT, BPL-003 is a benzoate formulation of 5-MeO-DMT and is administered as a dry powder intranasal spray. This dry powder formulation may provide potential benefits in tolerability and absorption characteristics, and could potentially change the manner in which patients experience the treatment. Both BPL-002 and BPL-003 use FDA approved intranasal delivery devices.

The data from both Phase 1 studies will then be analysed to determine which formulation will be used in the upcoming Phase 2 studies, aimed at evaluating the use of 5-MeO-DMT in combination with assisted psychotherapy in the treatment of treatment resistant depression (TRD) and other indications.

Dr Frank Wiegand, CMO of Beckley Psytech, said: “At Beckley Psytech patients are at the centre of everything we do. Therefore we are thrilled with the initiation of this second Phase 1 study which is investigating our innovative dry powder formulation for its potential to optimise the delivery of 5-MeO-DMT, through improved tolerability and adsorption characteristics. The results from this study will allow us to determine the optimal formulation for our upcoming proof of concept and Phase 2 studies in TRD and the other indications we will be exploring.”

Cosmo Feilding Mellen, CEO of Beckley Psytech, added: “We are committed to exploring the full therapeutic potential of psychedelic medicines. By looking to tailor the potential therapeutic effects of these compounds through dose and delivery mechanisms, such as FDA approved devices, we aim to optimise treatment outcomes and reduce the burden on the patient, healthcare systems and society.”

Phase 1 study overview

The Phase 1 study is a double-blind, randomised, single ascending dose trial, with psychedelic-naïve healthy volunteers. The study will enrol up to 36 volunteers to evaluate the safety and pharmacokinetic characteristics of a dry powder intranasal spray of 5-MeO-DMT. The trial will also look to characterise the psychedelic experience of the subjects, with several scales and micro-phenomenology interviews carried out by a specialist to fully understand the experience of each individual.

Beckley Psytech – www.beckleypsytech.com

Beckley Psytech is a clinical stage privately held company dedicated to helping patients suffering from neurological and psychiatric disorders by developing a broad pipeline of psychedelic compounds in rare and more common diseases. Our vision is for clinically validated psychedelic medicines to be integrated into modern medical practice in order to help patients with high unmet medical need around the world suffering with treatment resistant depression, and other profoundly debilitating neurological conditions. Beckley Psytech was founded in 2019 leveraging some of the expertise developed over more than 20 years by the Beckley Foundation, an independent non-profit and world leader in psychedelic medicine research, and is based out of Oxford, United Kingdom.

Contacts

Beckley Psytech
Cosmo Feilding Mellen
Chief Executive Officer
info@beckleypsytech.com

Communications
FTI Consulting
Ben Atwell / Mike Trace
+44 (0)20 3727 1000
beckleypsytech@fticonsulting.com

Investor Relations
LifeSci Advisors
Guillaume van Renterghem
+41 76 735 01 31
gvanrenterghem@lifesciadvisors.com

Why the UK is becoming a psychedelic hotspot

Brexit Britain becomes unlikely psychedelic haven as Albert Labs IPOs

The UK is on a mission to create a world-leading clinical research ecosystem that’s more efficient and effective than ever before – and many psychedelic companies are taking advantage of the regulatory changes.

To reach this goal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) now allows “real world data” (data collected from patients and healthcare systems outside of clinical trials) to aid in the drug approval process

This may bring psychedelic therapies to market much faster not only in the UK, but also in Australia, Canada, Singapore and Switzerland, as the MHRA joined a coalition with these countries called the Access Consortium.

Additionally, the UK may reschedule psilocybin to Schedule 2, reducing barriers to clinical research.

Just yesterday, COMPASS Pathways (CMPS) announced a strategic partnership to launch a major psychedelic research center in the UK.

Other companies to keep an eye on that may benefit from these changes include Albert Labs (ABRT), Awakn Life Sciences (AWKN), Small Pharma (DMT), Beckley Psytech, Eleusis.

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$80M raised to study a condition you’ve never heard of

Beckley Psytech completes oversubscribed $80m (£58m) fundraise to develop portfolio of psychedelic medicine breakthroughs

A private company based in England called Beckley Psytech raised $80M in a Series B financing round, exceeding the $50M target due to overwhelming interest from investors.

The funds will be used to study low doses of psilocybin in patients with a rare headache condition called short-lasting unilateral neuralgiform headache attacks (SUNHA), which affects just 45,000 people in the US and Europe. The Phase 1b study is already underway at King’s College London.

The proceeds will also be used to develop new proprietary compounds, and to study the company’s novel formulation of 5-MeO-DMT, a psychedelic compound found in toad venom, in treating depression.

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