Esketamine Hydrochloride

AUCKLAND, New Zealand, June 24, 2024 /PRNewswire/ -- Douglas Pharmaceuticals, New Zealand's largest pharmaceutical company, is pleased to announce that results from their recent trial, "Randomised Placebo-Controlled Phase 2 Study of Extended-Release Ketamine Tablets (R-107) for Treatment-Resistant Depression", also known as the BEDROC study, have just been published by the leading scientific journal Nature Medicine. Douglas Pharmaceuticals' Chief Scientific Officer, Dr Peter Surman, commented, "We're pleased that the quality and design of the study, as well as the significance of the findings have been recognised and are now being shared with industry peers. Should R-107 perform in Phase 3 studies as in the BEDROC study this would be a life-changing medication for many individuals who suffer from Treatment-Resistant Depression (TRD), and one that could be taken safely at-home." The BEDROC study enrolled patients with TRD who had failed two or more antidepressants in the current period of depression. Patients responded rapidly to R-107 during the daily dose induction phase of BEDROC and around 73% (168/231) of patients were responders after 1 week. This response rate is comparable to results achieved with off-label IV ketamine treated TRD patients but without undesirable dissociation (spacing out). R-107 shows promise to be a rapid acting, convenient and accessible form of ketamine. Dr Surman acknowledged the valuable contributions made by Douglas' Product Development Team, the investigators involved, and Professor Paul Glue, MD, University of Otago, Hazel Buckland Professor, Chair of the Trial Steering Committee for BEDROC. Professor Glue has worked closely with Douglas as a consultant and serves as the Clinical Advisory Board Chair for R-107. With over 20 years of pharmaceutical experience, Professor Glue specialises in mood disorder research, including the use of ketamine for TRD. Professor Glue commented, "The BEDROC study shows that it is possible to achieve a robust anti-depressant response from ketamine without significant dissociation. We saw a clear dose response effect over 3 months and met the primary efficacy endpoint at Day 92 with significant separation from placebo in the 180 mg dose arm. This gives us confidence to proceed to pivotal registrational clinical studies." The results of the BEDROC study revealed that R-107 was well tolerated, and this was confirmed by the follow-up 6 months open-label study BEDROC-1. Most adverse events (AEs) were mild with no safety signals encountered. Dissociation and sedation AEs when administering ketamine or esketamine (one of the active components of ketamine) from rapid releasing dosage forms such as intranasal esketamine (56, 84 mg) are so significant that the product must be administered in a clinic with an observation period of at least 90 minutes after dosing. In the BEDROC study, dissociation and sedation AEs were mild and patients took R-107 at home without any safety issues. Upon completing up to 9 months of treatment on R-107 in BEDROC and BEDROC-1 a significant portion of patients (106) were enrolled in a compassionate use program where the mean duration of treatment is currently 2 years. Most patients have continued to be treated with 180 mg of R-107 twice a week. The peer-reviewed full manuscript can be accessed here: For further information, please contact: Lisa Craigie Chief Legal & Commercial Officer Douglas Pharmaceuticals Email: [email protected] About Treatment Resistant Depression About 60 million patients in the United States and Europe suffer from Major Depressive Disorder (MDD). Roughly one third of MDD patients are classified as being treatment resistant, in that they have failed two or more antidepressants in the current period of depression. About R-107 R-107 is a proprietary, extended-release oral dose of ketamine developed for the treatment of patients with TRD. After administration the active ingredient ketamine is released at a slow, steady rate. The reduction in dissociative side effects is attributed to a low systemic concentration of ketamine. An IND is open with the US FDA for all studies needed to support a regulatory submission. Douglas is open to meeting potential partners and investors interested in collaborating to complete the Phase 3 development of R-107 and prepare it for commercialisation. For more information, please visit: A world-first at home treatment for Treatment Resistant Depression - R-107 on Vimeo About Douglas Pharmaceuticals Douglas Pharmaceuticals is a privately held pharmaceutical company headquartered in Auckland, New Zealand. Douglas Pharmaceuticals is a developer and manufacturer of generic and repurposed medicines sold in the US, Europe and in over 40 markets globally. The Douglas mission is to 'Improve Lives' by providing innovative, competitive, and high-quality healthcare solutions. Douglas' core business is producing prescription drugs for areas including oncology, dermatology, the central nervous system, and immunology. Douglas develops, manufactures, and distributes novel and generic products, with a preference for those where there is a strong intellectual property position as well as technical complexity in areas of high unmet need. For more information, please visit: About Nature Medicine Nature Medicine is a world-leading, peer-reviewed scientific journal that covers all aspects of research related to medicine. The journal has a 2022 2-year impact factor of 82.9. SOURCE Douglas Pharmaceuticals Ltd

ELE-101 is a patent-protected, synthetic formulation of psilocin, designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours.The Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single intravenous (IV) dose of ELE-101 in 6-12 participants with Major Depressive Disorder (MDD). Results are expected in H2 2024.The dose for Phase 2a was selected using preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1 randomized, double-blind, placebo-controlled, single ascending dose part of the study of ELE-101 in healthy participants, which showed that it was well-tolerated with no serious adverse events. ELE-101 showed a dose-proportional PK profile and a reliable induction of short-duration psychedelic experiences. NEW YORK and BERLIN, June 20, 2024 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced an update on Beckley Psytech’s Phase 1/2a trial of ELE-101 (NCT05434156) for people living with MDD, with initial results from Phase 1 and the dosing of the first patients in the Phase 2a part of the study. ELE-101, a patent-protected IV formulation of psilocin, has been designed to provide consistent and controllable drug delivery in patients with neuropsychiatric conditions. As the active metabolite of psilocybin, psilocin has the potential to offer a rapid onset, significantly shorter treatment duration, and reduced inter-subject variability compared to oral formulations of psilocybin. This could enhance convenience and therapeutic outcomes for patients with depression while reducing the resource burden on healthcare systems. The open-label Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single IV dose of ELE-101 in 6-12 patients diagnosed with MDD. Patients will be assessed at various time points in the study for up to three months after dosing, with results expected in H2 2024. The dose was selected using preliminary PK/PD data from the Phase 1 part of the study, a randomized, double-blind, placebo-controlled, single ascending dose study of ELE-101 in healthy participants. Initial data from Phase 1 supports the differentiated profile of ELE-101, showing that ELE-101: Was well-tolerated with no serious or severe adverse events (AE) reported, and an AE profile which is consistent with other compounds in this class.Demonstrated a dose-proportional PK profile, leading to reduced inter-subject variability compared to oral psilocybin.Induced high-intensity, short-duration psychedelic experiences, suggesting a potential treatment time of approximately two hours in the clinic. If validated in further studies, these findings could support the development of a scalable treatment model similar to the established paradigm of Spravato®, an esketamine nasal spray for treatment-resistant depression. Full data from the Phase 1 study is expected to be published at a later date. Commenting on the news, Dr Srinivas Rao, Co-CEO of atai said: “The data so far on ELE-101 indicates its potential as a promising candidate for treating depression. The consistent dose delivery and dose-proportional pharmacokinetic profile are particularly encouraging, as this could reduce variability among patients. At atai we are building a pipeline of short-duration psychedelics that target in-clinic treatments of approximately two hours. In addition to ELE-101, we believe Beckley Psytech’s lead candidate, BPL-003 (an intranasal 5-MeO-DMT), and our VLS-01 (an oral transmucosal formulation of DMT) could also fit this model.” About atai Life Sciences atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and was founded as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients. atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life. About Beckley Psytech Beckley Psytech is a private clinical-stage biopharmaceutical company focused on improving the lives of people with neuropsychiatric disorders through the development of rapid-acting, short-duration psychedelic medicines. In January 2024, atai made a strategic investment in Beckley Psytech, resulting in a 35.5% ownership stake and 1:1 warrant coverage at a 30% premium on the primary issuances. atai holds a time-limited right of first refusal on a future sale of the company and an indefinite right of first negotiation for BPL-003 and ELE-101. atai and Beckley Psytech also agreed to collaborate on digital therapeutics, commercial and market access activities in preparation for future potential commercialization. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: expectations regarding the progress of preclinical and clinical trials and related milestones, including for ELE-101, BPL-003 and VLS-01; expectations regarding our strategic investment in Beckley Psytech our business strategy and plans; and the plans and objectives of management for future operations and capital expenditures. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law. Contact Information Investor Contact: IR@atai.life Media Contact: PR@atai.life