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Pre-IND meeting granted for psychedelic drug targeting TRD

The New Chemical Entity (NCE), Triptax, has been developed by Biomind Labs for treatment-resistant depression.

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Pre-IND meeting granted for psychedelic drug targeting TRD

Biomind Labs has confirmed that it has had a Pre-Investigational New Drug (Pre-IND) meeting granted by the U.S. Food and Drug Administration (FDA) for Triptax™.

The company has submitted a briefing package to the Division of Psychiatry, Center for Drug Evaluation and Research at the FDA and is now waiting for further feedback.

The Pre-IND meeting is a critical step in the U.S. regulatory approval process that provides an opportunity for the company and the FDA to discuss the NCE development plan and to obtain the FDA’s guidance for new clinical trials that Biomind Labs may conduct on the NCE Triptax™.

See also  IND application submitted for psilocybin alcohol use disorder programme

CEO of Biomind Labs, Alejandro Antalich, commented: “This is a new major step in our expansion to the U.S. to upgrade our clinical pipeline. Our NCE Triptax™ could be used as an active pharmaceutical ingredient or as a chemical precursor of Biomind’s novel formulations to treat depression, specifically Treatment-Resistant Depression, a Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat current depressive episodes.

“The meeting granted by the FDA comes at the right moment, as we are finalising processing the clinical data from the first part of our Phase II trial of our novel drug candidate BMND01 for Treatment-Resistant Depression, a key element to support the design of our future investigational new drug clinical trials to be conducted in the U.S.

“Our main focus is to rapidly advance on our clinical pipeline to get the first registered pharmaceutical drug ready to be used by millions of patients across the world, while considering what is needed to secure the required funding to support large-scale clinical trials, such as democratic access, demonstrated efficacy, and safety and compliance with regulatory authorities.”

The company states it is focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules, 

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Major deals continue positive trajectory for psychedelics in 2024

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“Enhanced Consciousness Index” tracked by new psychedelics ETF

Psychedelics started 2024 with a bang, and the innovative medicines are continuing to gain traction as the year progresses. This week saw one of the globe’s top five biggest pharmaceutical companies – AbbVie – enter the market, while Enveric and MindBio signed a $66.5 million deal.

2024 set off to a strong start for psychedelic medicines with several watershed moments that are setting the stage for the sector’s acceleration.

These include developments such as the FDA’s acceptance of Lykos Therapeutics’ NDA for MDMA-assisted therapy for PTSD, Beckley Psytech’s securement of $50M investment from atai Life Sciences to expedite its assets through Phase 2 trials, a European Medicines Agency meeting on regulating psychedelics, and the confirmation from the UK’s independent policy body POST that it will publish a major briefing on psychedelic drugs to treat mental health conditions later this year, among others.

The positive developments for the industry are continuing, with this week seeing pharmaceutical company AbbVie – which has a clinical pipeline covering neuroscience, immunology, oncology, and eyecare – entering the industry through a new $65 million partnership with psychedelic drug developer Gilgamesh Pharmaceuticals.

Next generation neuroplastogens

The companies have stated they will be working together to discover and deliver next-generation psychedelics for mental health conditions such as anxiety, depression, and PTSD, as well as addiction.

AbbVie has highlighted the challenges posed by first-gen psychedelics including necessitating in-office administration and concomitant supportive care due to their hallucinogenic component – elements that could hinder the adoption and scale-up of these medicines.

See also  MDMA for PTSD receives priority review for New Drug Application

Gilgamesh Pharmaceuticals is working on the development of next-gen compounds that aim to improve the safety and efficacy of first-generation psychedelics and remove the hallucinogenic component, including a short-acting 5-HT2A agonist and an Ibogaine analogue.

In a press statement, Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research at AbbVie, commented: “Significant unmet need remains for people living with psychiatric disorders and we know that to innovate in this field, we need to pursue novel technologies and approaches.

See also  UK advisory body issues rapid response on psychedelics for PTSD

“We look forward to working with Gilgamesh’s world-class team to advance the development of novel neuroplastogens and pave the way for additional treatment approaches in psychiatry.”

Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals, added: “We are thrilled to partner with AbbVie, a global pharmaceutical company focused on innovation in psychiatric care, to address the pressing challenges in mental health treatment.

“Our collaboration will pioneer research of a new generation of therapies that hold great potential for improving patient outcomes.”

AbbVie is now the latest major pharmaceutical company to enter this market, following the likes of Janssen and Janssen and Otsuka Pharmaceutical, indicating that mainstream pharma is taking the promise of psychedelic medicines seriously.

However, this was not the only major deal to take place in the psychedelics market this week.

Enveric Biosciences also signed a $66.5 million non-binding term sheet with MindBio Therapeutics to out-license its novel psilocin prodrug candidate for mental health disorders.

Similar to Gilgamesh Pharmaceuticals, Enveric and MindBio focus on the development of next-generation neuroplastogens for that have reduced the hallucinogenic component.

Under the non-binding term sheet, Enveric will out-license a class of Novel Psilocin Prodrugs (NPP) to MindBio – a group of molecules that the company says are designed to be metabolised specifically to release therapeutic levels of systemic psilocin at varying rates.

In a press statement, Joseph Tucker, Ph.D., Director and CEO of Enveric, commented: “We look forward to working with MindBio’s team, which is pioneering an important part of the exciting psychedelic space, focused on controlling dose to reduce or eliminate hallucinations associated with these powerful compounds.

“This non-binding term sheet highlights the potential synergies between the Enveric and MindBio approaches to leveraging psychedelic-based compounds to target specific signaling pathways in the brain for the treatment of neuropsychiatric conditions.”

“We are pleased to explore an opportunity to draw on the molecular discovery engine at Enveric and believe this novel and patented asset significantly strengthens our intellectual property pipeline and aligns with our strategy to develop innovative, protected compounds with fine-tuned formulation and dosing strategies,” added CEO of MindBio, Justin Hanka.

“We look forward to the prospect of progressing this asset into clinical trials as we seek to bring important and beneficial therapies to patients in need.”

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Psychedelics in 2024: a year for investment

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Psychedelics in 2024: a year for investment

Following several transformative milestones in psychedelics, coupled with a surge in biotech investment, 2024 is set to see a profound shift for the sector as investors turn their attention toward solutions in mental health.

With a remarkable 48% surge in biotech investment in the UK recorded between June and August 2023, according to data from the UK BioIndustry Association (BIA) and Clarivate, the financial landscape is ripe for innovative ventures.

This increase in investment followed the introduction of a new pension reform package which includes the Mansion House Compact. This allows pension providers to allocate 5% of default pension allocations to unlisted equity, which could equate to a massive £50bn in investment for UK companies.

Specific sectors highlighted for allocation include fintech, life sciences, biotech, and clean technology in order to create growth and support jobs across the UK.

This development presents a unique opportunity for the UK’s psychedelics industry to thrive.

Psychedelic developments

Parallel to this influx of biotech investment, the psychedelics industry has recently seen several watershed moments that are setting the stage for the sector’s acceleration.

In January 2024, UK-based Beckley Psytech secured $50M investment from atai Life Sciences to expedite the development of Beckley’s psychedelic assets through Phase 2 trials.

Multiple clinical readouts are expected from Beckley this year, including from its Phase 2a trial for Alcohol Use Disorder in mid-2024 and a Phase 2b readout of BPL-003, Beckley’s intranasal 5-MeO-DMT, for Treatment Resistant Depression in the second half of 2024.

See also  Negev: funding psychedelic research in Europe and North America

Additionally, Canadian-based Filament Health announced that the FDA has accepted its Investigational New Drug application for PEX010, a botanical psilocybin drug candidate aimed at treating Substance Use Disorders (SUD).

February saw the FDA accept Lykos Therapeutics’ (formerly MAPS PBC) NDA for MDMA-assisted therapy for PTSD. The application has been granted Priority Review and the FDA is expected to announce its decision in August 2024. If approved, this will be a major development for psychedelic therapies following two decades of research by MAPS.

Elsewhere across the globe, 2024 has already seen the European Medicines Agency confirm it will be holding a meeting on psychedelics in April to help shape regulatory guidance, and the UK’s independent body, POST, confirm it intends to publish a major briefing on psychedelic drugs to treat mental health conditions later this year.

The decision to publish the briefing followed the country’s first parliamentary debate on access to psychedelics in 2023.

Furthermore, Australia’s MindBio Therapeutics announced results from its pioneering Phase 2a take-home microdosing trial of its proprietary titratable form of LSD, MB22001.

The study showcased rapid and statistically significant improvements in depressive symptoms, with a 60% reduction observed and 53% of patients achieving complete remission from depression. The compound was shown to be safe and well-tolerated, with no treatment-related severe or serious adverse events reported.

These results mark a significant milestone in understanding the potential for scaling up psychedelic therapies, and the company is working on building a proprietary treatment model that is scalable, safe and effective, and can be tailored to patients as a first-line treatment for depression.

Speaking to Psychedelic Health, Co-Founder & Chief Executive Director of MindBio Therapeutics, Justin Hanka, stated: “Microdosing is a scalable way to treat millions of people suffering from these conditions with psychedelic medicines and this data just confirms it is safe and effective and justifies the progress of this research in advanced stage clinical trials.”

Most recently, Cybin announced it had received FDA Breakthrough Therapy Designation for its novel psychedelic molecule CYB003. This will provide an expedited review pathway and increased access to FDA guidance on trial design, as well as the potential to reduce drug development timelines.

Cybin CEO, Doug Drysdale, stated: “The granting of Breakthrough Therapy Designation by the FDA underscores the potential of CYB003 to fill a gap in the treatment landscape for MDD and serves to expedite and de-risk our development programme going forward.

“This designation provides for a streamlined review process and enhanced engagement with the FDA. With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously. We are grateful for the opportunity to accelerate the development and regulatory review process that this designation affords, as we prepare to advance CYB003 toward a Phase 3 pivotal trial around mid-year.”

The company also announced its oversubscribed private placement of US$150m in March, led by Deep Track Capital and includes participation from RA Capital Management, Avidity Partners, Acorn Bioventures, Altium Capital, Logos Capital, Octagon Capital, Rosalind Advisors, Sphera Healthcare and other institutional investors. The net proceeds will be used for Phase 3 drug development activities for CYB003, working capital and general corporate purposes.

Adding to these developments, the FDA recently gave Breakthrough Therapy Designation to Australia-based MindMed’s MM120 (LSD) programme for the treatment of generalised anxiety disorder (GAD), another bolster for psychedelic therapies.

Robert Barrow, Chief Executive Officer and Director of MindMed, stated: “The FDA’s decision to designate MM120 as a breakthrough therapy for GAD and the durability data from our Phase 2b study provides further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD.”

Supporting investment

Israel-based Negev Capital, a biotech venture capital firm in the psychedelics-based medical R&D space, saw its successful first fund of $31 million invested across 27 companies including Beckley Psytech, MindBio and Filament Health.

Ken Belotsky, Partner at Negev Capital, commented: “We remain dedicated to supporting and investing in the future of psychedelic medicine and see 2024 as a watershed year for the sector.

“These recent achievements of just some of our portfolio companies underscore the immense potential of psychedelics-based compounds to revolutionise treatment of a wide range of mental health conditions, substance use disorders and other illnesses.’’

These major developments underscore a growing confidence in the potential of psychedelics to revolutionise healthcare and wellness, and investors are set to capitalise on their therapeutic potential bringing in a wave of investment.

The rest of 2024 is set to see regulatory approvals in the US and the advancement of clinical milestones which could see major shifts in valuations for companies in the sector.

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Europe to establish regulatory guidance on psychedelics in 2024 

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Europe to establish regulatory guidance on psychedelics in 2024 

The European Medicines Agency (EMA) is set to hold a multi-stakeholder workshop on medical psychedelics in April 2024 to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe.

In what marks an important next step for psychedelics in Europe, the workshop – Towards an EU regulatory framework – will bring together patients, healthcare professionals, academia, regulators and industry.

The meeting is being held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics.

See also  PAREA launches psychedelics manifesto for mental health in Europe

The MEPs wrote to the European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organisations need to play a more active role in the advancement of psychedelic medicines in Europe.

The letter states the EMA recognises that mental health conditions and substance use disorders are one of the highest public health challenges in Europe, and that the organisation is closely following the developments in the field of psychedelic-assisted therapies.

Signatories of the letter included MEPs Alex Agius Saliba, Robert Biedroń and Sara Cerdas of S&D, Jarosław Duda of the EPP, Tilly Metz of the Greens and European Free Alliance, and Frédérique Ries of Renew Europe.

The EMA previously responded to the MEP’s letters confirming the organisation will cooperate with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) on psychedelic substances.

The workshop will discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health across Europe.

The EMA has stated that the workshop will cover research methodology, regulatory processes and requirements and the relevance of real-world data, and aims to:

  • Hear the views of stakeholders and experts on the therapeutic potential of psychedelics;
  • Provide further clarity on defining the safe and effective use of psychedelics;
  • Inform on regulatory challenges associated with the development and evaluation of psychedelic medicines;
  • Define areas for which further regulatory guidance is required.

The meeting will be held from 16 to 17 April.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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