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Company raises $60m to advance 5-MeO-DMT therapeutics

Lusaris Therapeutics has launched with its Series A financing.



Company raises $60m to advance 5-MeO-DMT therapeutics

Biotechnology company Lusaris Therapeutics – which has a lead programme focusing on DMT for treatment-resistant depression – has launched with its Series A financing of US$60 million (~£52.01m).

Lusaris Therapeutics’ lead programme, LSR-1019, is a sublingual formulation of 5-MeO-DMT, a fast-acting and rapidly clearing serotonergic psychedelic. The formulation is being developed for patients with treatment-resistant depression (TRD) and other severe neuropsychiatric disorders.

RA Capital Management incubated Lusaris and led the Series A round with participation from leading healthcare investors including Venrock Healthcare Capital Partners, Deep Track Capital, Boxer Capital, and an additional undisclosed investor.

See also  Training of therapists begins in advance of 5-MeO-DMT clinical trial

Interim Chief Executive Officer of Lusaris and Partner and Managing Director at RA Capital, Andrew Levin, M.D., Ph.D., commented: “Major depressive disorder is a severe, debilitating, and inadequately treated disease resulting in millions of patients progressing to TRD. 

“Psychoplastogens have emerged as a promising treatment approach supported by compelling scientific evidence in patients with TRD and other severe neuropsychiatric conditions. 

“We believe LSR-1019, our proprietary sublingual formulation of 5-MeO-DMT, has the potential to provide an important therapeutic advance for patients with severe depression who lack effective treatment options.”

The need for innovation in TRD care

TRD occurs when patients with major depressive disorder do not respond adequately to two lines of therapy. There is a tremendous need for new therapies for patients not adequately controlled with currently available treatments. 

Serotonergic neuroplastogens have been shown to induce favourable structural and functional neural plasticity, resulting in rapid and dramatic improvement in patients with TRD. 

Existing clinical data suggest that 5-MeO-DMT has the potential to offer best-in-class efficacy in people with TRD.

Orally administered 5-MeO-DMT is pharmacologically inactive due to rapid metabolism by enzymes in the gut and liver. LSR-1019 is a proprietary sublingual tablet formulation of 5-MeO-DMT that dissolves under the tongue within seconds and is absorbed without the need for water. 

This approach is scalable, eliminates the need for burdensome drug delivery systems, simplifies administration, and offers the potential for more consistent exposure and more predictable therapeutic benefit in patients. Lusaris plans to develop LSR-1019 for the treatment of TRD and additional severe neuropsychiatric disorders. Phase 1 clinical studies of LSR-1019 are expected to initiate imminently with topline data available mid-year 2023.

Exclusive delivery technology

The company has also announced that it has entered into a strategic collaboration with Catalent under which Lusaris has been granted an exclusive worldwide license to Catalent’s Zydis® fast-dissolving tablet technology for the 5-MeO-DMT programme.

The Zydis ODT (orally disintegrating tablet) technology has been used in more than 35 commercial products in over 60 countries.

Chief Operating Officer at Lusaris, Neil Buckley, commented: “We aim to develop best-in-class neurotherapeutics that have the potential to reach more patients in need by decreasing the treatment burden on both patients and physicians.

“With encouraging preclinical data, a proven delivery technology, and an expected rapid and short psychotropic experience, LSR-1019 has the potential to be a transformative treatment for patients suffering from TRD and other serious mood disorders.”

In addition to LSR-1019, Lusaris is building a portfolio of novel serotonergic neuroplastogens for a wide range of neuropsychiatric and neurological conditions, including migraine and cluster headache.

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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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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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