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Cybin to acquire Small Pharma, creating largest DMT programme



Cybin to acquire Small Pharma, creating largest DMT programme

Cybin Inc. has confirmed it will acquire Small Pharma, combining to create the psychedelic industry’s largest and most advanced deuterated DMT programme.

UK-based Small Pharma is a biotechnology company focused on short-duration psychedelic therapies for mental health conditions.

The company has developed short-duration psychedelic therapies for mental health conditions, raising $63 million in capital since 2021. It has also released the first placebo-controlled efficacy results for DMT in the treatment of Major Depressive Disorder (MDD), progressing two clinical-stage DMT-based programmes, a pipeline of preclinical assets, and an IP portfolio.

Both Cybin and Small Pharma share a common goal of creating novel psychedelic-based therapeutics, and the duo’s combined DMT and deuterated DMT (dDMT) programmes together create the largest dataset of systematic research on these short-duration psychedelic molecules. 

See also  Cybin secures patent for psilocybin analogue

CEO of Cybin, ​Doug Drysdale, stated: “This transaction creates a clear market leader in novel psychedelic therapeutics. 

“The synergy of Cybin’s and Small Pharma’s development programmes, intellectual property and robust datasets enhances our leadership and expertise in developing potentially best-in-class, optimised psychedelic therapeutics, and positions the combined company to generate long-term value for all stakeholders. 

See also  Cybin: quantitative data insights into psychedelic therapy

“Our combined portfolios, having an increased number of potential value-catalysts, also create added opportunities to support future funding activities with no added debt. We look forward to welcoming our Small Pharma colleagues into the Cybin team.”

The combined entity will have a combined 158 pending patent applications, including two allowed applications and 28 granted patents protecting the combined companies’ clinical and preclinical molecules. 

CEO of Small Pharma, George Tziras, added: “This marks the beginning of an exciting new chapter for Small Pharma. Since 2015, we have been committed to our mission of accelerating patient access to transformative mental health treatments, and I am incredibly proud of the progress we have made. 

“Cybin shares both our vision and confidence in the potential of our programmes.

“Cybin’s senior listing on the NYSE American can also provide increased access to the broader and deeper capital markets of the United States. We look forward to combining the considerable strengths of our teams to create a category leader in novel psychedelic-based therapeutics and bring innovative mental health treatments to patients around the world.”

Cybin and Small Pharma have stated that the integrated DMT dataset from both companies represents an advanced and extensive DMT clinical program, including:

  • Phase 2 safety and efficacy data for IV DMT in patients with MDD (SPL026);
  • Extensive Phase 1 dataset for IV formulations of DMT and dDMT (CYB004e, CYB004, SPL026, SPL028);
  • Studies exploring more convenient and patient-friendly dosing methods (Phase 1 intramuscular SPL026 and SPL028; subcutaneous CYB004); and
  • Phase 1b safety and efficacy of SPL026 administered in conjunction with serotonin reuptake inhibitors (SSRIs) in patients with MDD, with data anticipated in late 2023. Encouraging results could broaden access to DMT-based therapies by removing the requirement for patients to be withdrawn from existing SSRI medication.

Data readouts from both companies’ Phase 1 deuterated programmes, CYB004 and SPL028 are anticipated by late 2023, which will enable an evaluation of formulations and administration routes, and an informed, data-driven approach to launching a Phase 2 efficacy study of dDMT in the United States early in 2024.

Cybin expects to report Phase 2 safety and efficacy data from its CYB003 deuterated psilocybin analog programme in participants with MDD, in late 2023. 

Plans are underway to scale the programme for Phase 3, including a partnership with a global clinical research organization, a streamlined EMBARK facilitator training program, and preparations for Good Manufacturing Practice (GMP) manufacturing of CYB003 capsules for pivotal clinical trial supplies. 

Cybin has also stated that it anticipates the potential for receiving Breakthrough Therapy designation from the FDA, subject to FDA approval, as early as late 2023.

Once the transaction is complete, it is expected that the Small Pharma Shares will be delisted from the TSXV and removed from the OTCQB market, and Small Pharma will cease to be a reporting issuer in each of the provinces and territories in Canada.

The combined company will remain headquartered in Toronto, with operations in Canada, the US, the UK, the Netherlands, and Ireland, and will continue to trade on the NYSE American and the Cboe Canada under the ticker “CYBN”.

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Markets & Industry

Psychedelic therapy programmes launch to address heartbreak, burnout and more



Psychedelic therapy programmes launch to address heartbreak, burnout and more

Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges. 

Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.

All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.

See also  Psychedelics for frontline workers, palliative care and eating disorders

The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.

Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.

Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.

“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”

“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.

“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”

Additional Mastermind programmes will be released in the coming months, including: Getting Unstuck, by Dr Elizabeth Lombardo; Beating Burnout, by Dr Shauna Shapiro; and Coping with Cravings, by Dr Jud Brewer

“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.

“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”

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Mychedelica launches to revolutionise psychedelic medicine



Mychedelica launches to revolutionise psychedelic medicine

A new company specialising in psychedelic medicine – mychedelica – is offering a comprehensive suite of services to support the advancement of this transformative field. 

With a team of experienced medical writers and research support specialists, mychedelica is committed to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in the psychedelic medicine space.

Psychedelic medicine is rapidly gaining recognition for its potential to treat a wide range of mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). However, the field is still in its early stages of development, and there is a critical need for high-quality medical writing and research support services to facilitate its progress.

CEO of mychedelica, Bilal Bham, commented: “We are thrilled to launch mychedelica and contribute to the advancement of psychedelic medicine.

“Our team of experienced professionals is dedicated to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in this groundbreaking field.”

mychedelica provides a comprehensive range of services, including:

Medical writing: Experienced medical writers will craft clinical trial protocols, regulatory submissions, and peer-reviewed publications, ensuring that research findings are communicated clearly and effectively.

Funding research support: Experts in grant writing and fundraising strategies will assist researchers in securing funding for their psychedelic medicine studies.

Regulatory consulting: mychedelica’s team of regulatory experts will navigate the complex regulatory landscape surrounding psychedelic medicine, ensuring that clinical trials and products comply with all applicable laws and regulations.

With its commitment to quality and innovation, mychedelica is poised to play a pivotal role in shaping the future of psychedelic medicine. The company’s services will empower researchers to conduct rigorous clinical trials, clinicians to provide effective treatments, and pharmaceutical companies to develop safe and effective psychedelic medicines.

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Markets & Industry

Short Wave Pharma: innovating eating disorder care with psychedelics



Short Wave Pharma: innovating eating disorder care psychedelics

Psychedelic Health speaks to Short Wave Pharma CEO Rivki Stern about the company’s plans to innovate eating disorder care through psychedelics and its recent acquisition by Psych Capital.

Short Wave Pharma was recently acquired by global investment firm Psych Capital. The companies are on a mission to transform mental health care, focusing on innovative approaches and treatments, including psychedelics, which are increasingly gaining acceptability as clinical research results accumulate.

Short Wave Pharma’s clinical programmes are particularly focused on Anorexia nervosa – a complex mental health condition with one of the highest fatality rates. Despite the condition being associated with high rates of suicide, it is a hugely underserved area of mental health, with no FDA-approved pharmacological drug, and a high rate of chronicity. 

See also  Psych Capital completes acquisition of Short Wave Pharma

The company has developed a novel delivery method and drug combination specifically designed to address the requirements of this vulnerable population. Short Wave focuses on methods of delivery that will be effective for Anorexia, which is a metabolic disease as well as a mental health condition. Its unique buccal film delivery method is intended to affect the brain while bypassing the liver and gut degradation through mucoadhesive absorption.

“Our goal is to alleviate, solve, and treat mental health conditions. It’s a dire need in our global society, and it’s constantly on the rise,” commented Stern. “Eating disorders are a very good example of that and we have seen a very alarming growth since COVID. 

“What drew our attention to psychedelics is that they have the potential to address very complex mental health diseases and have been designated by FDA as breakthrough medicine for life-threatening conditions.

“Because there are no current solutions, we must harness very innovative approaches and potential solutions. That’s why we started working with psychedelics which may be difficult because they are not regulated, but we don’t shy away from challenges.”

The company’s drug is based on psilocybin and another API which together utilise an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain. 

The delivery method is sensitive to the patients’ needs – who may not want to swallow or be injected – and is known for its high bioavailability. 

“By mucosal absorption, we are speeding the onset of the medicine and amplifying the impact which will help tackle the patients’ metabolic challenges and improve acceptance,” says Stern. 

The drug product and delivery method are currently in preparation for Phase 1 clinical studies, and in its current preclinical studies, the company is validating its delivery and expanded mechanisms of action. So far, initial safety results are positive, with a further, more in-depth toxicity study taking place. 

Psych Capital – which is a public investment and awareness platform for mental health, and has a portfolio of innovative companies – has supported Short Wave Pharma’s IP-driven approach to eating disorder care through its recent acquisition of the company.

Short Wave and Psych Capital say they are aligned in their missions to innovate mental healthcare and deliver transformative care in areas of high unmet need.

Stern commented: “We all share a passion for innovation and together have decades of experience in evaluating investments as well as scaling up R&D projects and start-ups in life sciences. 

“We have a shared commitment to alleviate the suffering from mental health. Every one of us has experienced the frustration and challenges of dealing with mental health issues.

“Together, we’re going to put this commitment into action, by bringing forth innovative solutions and developments and getting them through the first stages of development, from discovery through to early phases of clinical study. 

“With psychedelics components, this is extra challenging because of their status as scheduled drugs within a still evolving regulatory framework, which adds uncertainty to the drug development process. 

“Short Wave Pharma has operational expertise in early-stage drug development which will bring extra value to the group’s projects as they develop through our funnel and grow into promising candidates for mental healthcare.  

“We want to identify the gems, guide them through clinical development, and create the right network to attract the right partners for further development and commercialisation.”

Short Wave Pharma is planning to enter its treatment into clinical studies in 2024.

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