Helus Pharma is focused on psychedelic drug development, unique delivery mechanisms, improved novel compounds and protocols that target psychiatric and neurological conditions.
The company claims to be the company with the largest IP portfolio in the psychedelic drug development space with over 60 patents granted and more than 200 patents pending.
The company has over 50 proprietary molecules as well as pre-clinical studies.
DRUG PROGRAMS TARGET: Major depressive disorder, alcohol use disorder, anxiety and therapy resistant psychiatric disorders.
SUBSTANCE FOCUS: DMT and Psilocybin.
OWNERSHIP:
100% – Adelia Therapeutics
100% – Small Pharma
CLINICAL TRIALS: Yes.
NEWS & PARTNERSHIPS:
2020
The company entered into a collaboration agreement with Greenbrook TMS to establish mental health centers of excellence for the purpose of facilitating research and development of innovative psychedelic compound-based therapeutics for patients suffering from depression. Projects to pursue at the centers of excellence is further clinical research of the psychedelic compounds in Cybin’s development pipeline, developing a deeper understanding of psychedelic therapeutic delivery, including the feasibility and facilitating recruitment of clinical trial participants for upcoming clinical trials.
The company formed a strategic collaboration with the University of Washington to co-sponsor a randomized, placebo-controlled trial of psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-related distress.
The company acquired Adelia Therapeutics diversifying its development portfolio.
The company announced a strategic partnership with the Toronto Centre for Psychedelic Science.
The company entered into a feasibility agreement with IntelGenx for fast-acting orally-disolving pharmaceutical-grade psilocybin film.
2021
The company partnered with Kernel to leverage its neuroimaging technology Kernel Flow in its upcoming sponsored clinical work.
The company announced sponsorship of Kernel’s feasibility study of its Kernel Flow technology to measure Ketamine’s psychedelic effect on cerebral cortex hemodynamics.
The company signed a drug development agreement with Catalent for its fast-dissolve formulation of novel, deuterated tryptamine CYB003 which will use Catalent’s proprietary Zydis orally disintegrating tablet technology.
The company was awarded patent No. 17/394,038 related to CYB004.
The company announced it was awarded a grant for the first psychedelic treatment clinic at Lenox Hill Hospital, part of Northwell Health, to serve marginalized and underserved communities on the Upper East Side of Manhattan, New York. The program aims to become one of the first hospital-based clinical sites to offer psychedelic medicine in the United States with clinicians receiving training in MDMA-, ketamine- and tryptamine-assisted psychotherapy. Clinicians will also receive training in Cybin’s EMBARK, a transdiagnostic psychedelic psychotherapy model that can be adapted to address a range of clinical indications and populations.
The company was granted a Schedule I manufacturing license from the U.S. Drug Enforcement Agency to its research lab in the Boston area.
The company launched EMBARK, a psychedelic facilitator training program which is a transdiagnostic model that is adaptable to different clinical indications and challenges including depression, alcohol use disorder and anxiety.
2022
The company was awarded US patent No. 11,242,318 related to CYB004.
The company announced a partnership with The Chopra Foundation to increase education and awareness of the potential use of psychedelics in supporting well-being and mental health.
The company acquired a phase 1 DMT study from Entheon Biomedical which is expected to accelerate the clinical development path of CYB004 by approximately 9 months. The company also entered into a data license agreement with Entheon that permits Entheon to access certain data to support the Entheon IQ program.
The company acquired a phase 1 DMT study from Entheon Biomedical which is expected to accelerate the clinical development path of CYB004 by approximately 9 months and will replace Cybin’s planned pilot study for CYB004 that was expected to commence in the third quarter of 2022. The company also entered into a data license agreement with Entheon that permits Entheon to access certain data to support the Entheon IQ program. .
2023
The company was awarded US patent No. 11,746,088, covering composition of matter for deuterated tryptamine compounds and pharmaceutical compositions thereof, with exclusivity until 2041.
The company was awarded US patent No. 11,724,985, to a deuterated psilocybin analog in the Company’s CYB003 investigational drug program. The patent, which is expected to provide exclusivity until 2041, includes composition of matter claims to deuterated tryptamines in support of the company’s clinical-stage programs, CYB003 and CYB004, in addition to other of the company’s pre-clinical programs, as well as claims directed towards methods of treating major depressive disorder and treatment-resistant depression.
The company announced that it has commenced the development of a streamlined, scalable version of its EMBARK Training Program, known as EMBARKCT which marks an evolution of EMBARK and has been specifically developed with the goal of increasing Cybin’s ability to effectively screen, qualify, train and certify facilitators to participate in future pivotal studies of its lead candidates, CYB003 and CYB004 for the potential treatment of generalized anxiety disorder.
The company launched EMBARK Open Access, the first free online course providing facilitator training for psychedelic therapy.
The company launched a website for EMBARK and announced EMBARK Open Access, the first free online course providing facilitator training for psychedelic therapy.
The company announced an agreement with Fluence to support the streamlining and scaling of Cybin’s EMBARK facilitator training program in preparation for a multi-site, global phase 3 trial of CYB003.
The company was awarded US patent No. 11,834,410 in support of its CYB003 program. The patent, which is expected to provide exclusivity until at least 2041, includes composition of matter claims to pharmaceutical compositions within the Company’s proprietary deuterated psilocybin analog program, CYB003, as well as claims directed toward the therapeutic treatment of major depressive disorder, treatment-resistant depression and alcohol use disorder.
The company announced that the European Patent Office granted patent No. 4,031,529 provides composition of matter protection for certain deuterated tryptamine compounds, including deuterated psilocybin analogs within the CYB003 program and deuterated analogs of DMT within Cybin’s DMT program, as well as their medical use.
The company was awarded US patent No. 11,771,681, which provides composition of matter protection for certain deuterated analogs of DMT as well as US patent no. 11,773,062, which provides protection for the medical use and the novel, efficient and scalable synthesis of certain analogs of DMT.
The company acquired Small Pharma creating the largest intellectual property portfolio in the psychedelic drug development sector with over 30 patents granted and 160 patents pending.
2024
The company announced that the Japanese Patent Office has granted JP patents 2023-500532 and 2023-533436. The patents, which are expected to provide exclusivity until at least 2040 and 2041, respectively, include protection for a synthesis method for the preparation of DMT and dDMT and injectable formulations within the Company’s proprietary DMT program in clinical development for the treatment of Generalized Anxiety Disorder.
The company received FDA Breakthrough Therapy Designation for its CYB003.
The company announced that the United States Patent and Trademark Office has granted U.S. patent 11,958,807 in support of its CYB003 program in Major Depressive Disorder. The patent is expected to provide exclusivity until at least 2041 and includes claims to pharmaceutical compositions within the company’s proprietary deuterated psilocybin analog program, CYB003.
The company’s research manuscript “Synthesis and Structure-Activity Relationships of 2,5-dimethoxy-4-substituted phenethylamines and the discovery of CYB210010: A potent, orally bioavailable and long-acting serotonin 5-HT2 receptor agonist” was published in the Journal of Medicinal Chemistry.
2025
The company partnered with Osmind for the acceleration of its commercial preparation for clinical-stage psychiatry programs. Osmind is a leading service provider advancing psychiatry through technology, services, and real-world evidence to bring innovative mental health treatments to patients in need.
The United States Patent and Trademark Office granted US patent 12,291,499 in support of the company’s CYB003 program in MDD.
The company engaged Thermo Fisher Scientific in supportof its Phase 3 clinical supply and potential commercial manufacturing of CYB003.
The United States Patent and Trademark Office granted US patent 12,318,477 in support of the company’s CYB004 deuterated DMT program in development for the treatment of generalized anxiety disorder. The patent is expected to provide exclusivity until 2040 and includes claims to novel formulations of DMT and deuterated isotopologues for intramuscular injection, including CYB004.
The company continued to scale its Strategic Site Partnership (SPA) program to power its Phase 3 PARADIGM study.
The company received UK MHRA approval to launch EMBRACE, the second Phase 3 study in its PARADIGM program. The trial will evaluate CYB003 as an adjunctive treatment for Major Depressive Disorder, enrolling 330 participants across 60 global sites.
2026
The company started trading on the Nasdaq.
The company rebranded to Helus Pharma from Cybin.