PsyRx
Unique solutions for depression
PsyRx advancing a novel drug for treating depression, a prevalent global ailment. The development employs cutting-edge manufacturing technology, combining a psychedelic substance with existing FDA-approved medication.
578% of funding target
Highlights
Highlights
PsyRx is developing a novel anti-depressant drug, which combines an ‘on shelf” drug from the SSRI family (the gold standard for pharmacological anti-depressant treatment) together with Ibogaine, a psychedelic compound.
Ibogaine displays a potentially wide range of therapeutic effects that can be beneficial for the treatment of depression. Based on studies carried out around the world, the assumption is that this combination will promote a positive and rapid effect within a few days, conversely to current SSRIs, whose effects only begin after a few weeks from the moment of taking the initial dose. Such reduced onset can be critical for those suffering from depression.
Moreover, it is known that currently available SSRIs have many side effects, such as fatigue, sexual dysfunction and weight gain, which may cause many patients to stop treatment, while Ibogaine-based medication may reduce these side effects significantly.
Self-production of active pharmaceutical ingredients (APIs)
In parallel to the development of the novel drug, PsyRx is developing innovative methods for the cultivation, production, extraction and separation of botanical sourced psychoactive molecules:
- Ibogaine extracted from the Voacanga Africana plant.
- Psilocybin extracted from “magic” mushrooms.
PsyRx does this through integrated Agro-Medical methods and bio-reactor technology, with the aim of producing pharma-grade APIs that can be used for the development of novel anti-depressant drugs, as well as drugs for other conditions. Such psychedelic-based treatments are currently in various stages of research and development for addiction (Ibogaine), depression (Psilocybin and Ketamine) trauma (MDMA) and other conditions.
This production is expected to be a significant source of income for the company.
Patent and competitive advantage
PsyRx has applied for a patent in several countries around the world regarding the combination of Ibogaine with an anti-depressant, which provides the company a significant competitive advantage. This patent has already been accepted in South Africa and is pending in many other countries.
Research collaborations
PsyRx has a cooperation agreement with the Hebrew University of Jerusalem (Faculty of Agriculture in Rehovot), which allows the development of methods for extracting, separating, cleaning and purifying a botanical material and turning it into APIs. The production is conducted according to good manufacturing practices (GMP). Commercial production of such APIs can be used for various applications, such as drug development by the pharmaceutical industry, preclinical and clinical studies, hospitals and mental health clinics (in regulated markets), and more.
In addition, the company has a signed sale agreement of Psilocybin for research purposes in Israel, and a signed cooperation agreement with the University of Athens.
PsyRx has received approval for safety and efficacy pre-clinical experiments from the regulatory bodies at the Israeli Ministry of Health.
Past investments in the company
The company has already raised millions of dollars from private investors in two fundraising rounds.
One of the investors in the company is the American NFT fund Trippy.VC, whose founders include Rowan Marley (Bob Marley's son) and Amare Stoudemire (NBA).
The team
The founders of the company have vast experience in establishing new companies and commercializing new products in the life sciences arena. The company's team consists of leading experts in the fields of medicine, biotechnology, drug development and business.
Prof. Itamar Grotto, chairman of the company's board of directors, is a doctor specializing in public health and a professor of epidemiology, who served at the Israeli Ministry of Health and was a member of the executive committee of the World Health Organization (WHO), Prof. Moshe Kotler is a former director of the Be'er Yaakov - Nes Ziona Mental Health hospital, Dr. Asher Holzer, co-founder, Has over 30 years‘ experience in management of both private and public corporations in the medical device and the biotech industry.
Dr. Kobi Boxdorf has over 10 years of experience in academic, industrial and managerial research, in the fields of microbiology, plant sciences and medical devices. These experts are joined by other leading entrepreneurs and scientific and medical professionals in various fields.
PsyRx's scientific and management team provides the company with the necessary expertise to realize the company's vision of providing innovative solutions for the treatment of depression.
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Pitch
Pitch
The problem
Mental health is in a global crisis. One out of every four people suffers from a mental problem, and thousands of people die tragically every year as a result of mental illness. The Covid-19 epidemic further increased prevalence, and the global economic consequences (e.g., loss of productivity) are estimated to reach trillions of dolars by 2030.
Depression is a common mental disease that has a significant impact on the patients' quality of life. Traditional treatments for these conditions often have long onset times and limited efficacy, as well as many side effects (e.g., weight gain, decreased libido, sleep problems).
Many patients (about 35%-40%) who suffer from major depression do not respond adequately to common treatments with SSRI antidepressants, do not improve, or show a partial response. In addition, many patients fail to complete treatment due to the side effects of these drugs. At the same time, patients experience functional impairment, poor quality of life, suicidal thoughts and suicide attempts, self-injurious behavior, and a high relapse rate.
The solution
PsyRx is developing a drug to treat depression through an innovative combination of Ibogaine with an antidepressant from the SSRI family that is already on the market.
Ibogaine is extracted from a botanical source, and its transformation into a pharma-grade API is carried out in a semi-synthetic process.
Psychedelic substances have been in use for healing and mental health care since the dawn of time. After being marginalized for political reasons for about five decades, recent years have shown a significant increase in research of these substances, which clearly and consistently show great potential for treating a variety of health conditions.
Several studies in addiction research have demonstrated the efficacy of Ibogaine and Noribogaine (a secondary metabolite of Ibogaine) to reduce self-administration or seeking of various addictive substances such as heroin, cocaine, morphine, methamphetamine, nicotine and alcohol. The data also indicate positive effects on psychological symptoms related to depression and trauma.
Recently, a clinical study providing Ibogaine for opiate withdrawal was approved in the USA.
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The technology
PsyRx uses innovative manufacturing technology. The technology is based on the use of tissue cultures for the production of a high and consistent yield of Psilocybin (using a bioreactor), and semi-synthetic Ibogaine from the Voacanga Africana plant. The cost of this production is significantly lower compared to currently used production methods.
Production of quality Psilocybin and Ibogaine APIs and the use of proper manufacturing conditions are a prerequisite for any drug development, but extracting these from the plant is a challenge. Currently, botanical psychoactive substances are produced using traditional agricultural methods, which have disadvantages such as contamination, use of pesticides, radiation and great variability of the active compounds.
Today it is almost impossible to buy botanical-based Psilocybin and Ibogaine molecules that were produced under adequate production conditions necessary for human use. Therefore, the vast majority of current research and development in the field is based on synthetic molecules that differ in some of their properties from the botanic material.
In addition, there is a demand from pharmaceutical companies, mental health clinics, and research centers, for an active substance from botanical sources that is produced under proper conditions, with high quality and in a consistent fashion.
The technology developed by PsyRx enables the production of API Ibogaine from the root bark of the Voacanga Africana plant and the production of API Psilocybin from tissue cultures.
PsyRx's bioreactor technology offers a fast, efficient and reliable way to produce Ibogaine and Psilocybin under proper manufacturing conditions (GMP standard), through the development of a precise process in a controlled environment, which brings our products to the highest quality.
These molecules are also produced at a fast pace, which is significantly more efficient compared to current production methods. The process allows the company to produce a large amount of material at a low cost, thereby selling the material to pharmaceutical companies and research and development institutes, while at the same time developing an in-house drug, at an affordable price and with high profit margins.
These are great news for those using, producing and developing drugs based on these molecules.
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(bioreactors in PsyRx's labs)
Intellectual Property
PsyRx submitted a patent application in 2021 and is on track to obtain strong intellectual property covering the combination of Ibogaine and antidepressants. PsyRx works with Luthi + Webb, one of the leading patent attorneys' offices in Israel, which specializes in patent registration and protection. This strong IP base should provide a strict barrier against potential competitors.
Collaborations
PsyRx has signed a cooperation agreement with the Tech Transfer company "Yissum" of the Hebrew University of Jerusalem (Faculty of Agriculture in Rehovot). This agreement allows the development of a method for extracting, distilling, purifying and purifying a plant-based psychedelic molecules (Ibogaine and Psilocybin) and turning it into a GMP-level APIs for various uses: clinical studies, mental health clinics (treatment in regulated markets), etc.
The business model
The company's business model consists of the following factors:
- Selling an improved antidepressant.
- Signing licensing agreements for the production and marketing of psychiatric drugs. The company plans to combine existing drugs with Ibogaine to increase effectiveness and reduce side effects.
- Sale of API Psilocybin and Ibogaine for research and drug development.
- Sublicense or transfer of technology usage rights to a third party in exchange for royalties.
- Establishment of joint ventures with companies developing drugs based on Psilocybin and Ibogaine for various indications.
In the first stage, the company will produce raw material which will be sold to potential customers such as commercial companies and research institutions, for the purpose of experiments and medical developments.
PsyRx in the media
Team
Team
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Has over 25 years of experience in the pharmaceutical industry. Yoav served as CEO of Tarima Pharmaceuticals Ltd. between 2013 and 2018. Between 2001 and 2012, Yoav founded and managed Novartis Oncology in Israel and then expanded its activities to the developing countries of Eastern Europe. During last year‘s Yoav was an advisor to pharma companies, medical cannabis and medical startup companies. Holds a master‘s degree in business administration MBA from Bar Ilan University and a bachelor‘s degree in pharmacy from the Hebrew University, school of pharmacy, Jerusalem.
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Has over 30 years‘ experience in management of both private and public corporations in the medical device and the biotech industry. His expertise covers a wide range of activities including product development, clinical studies, regulatory affairs and marketing. Asher founded several successful biotech companies and served as their chairman and president. These included InspireMD (NYSE MKT: NSPR), a medical device company which improves treatment of patients undergoing heart stenting and UroGen Pharma (NASDAQ: URGN) focusing on developing therapies for urological pathologies. Asher was part of the management team of Biosense which was acquired by Johnson & Johnson in 1997 and became the worldwide market leader in developing and marketing products for the diagnosis and treatment of cardiac arrhythmias. He holds a Ph.D. in Applied Physics and a M.Sc. in Material Science from Hebrew University in Jerusalem, Israel. He holds several granted and pending patents, mainly in the fields of interventional cardiology and urology.
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Entrepreneur with experience in the private and public sector. He initiated the first IPO of a medical cannabis company on the Tel Aviv Stock Exchange. He served as the CEO of Hi-Pharma a medical cannabis company and COO of Palgi Sharon - Israeli Municipal Water Corporation. He holds a degree in Water & Soil Engineering from the Ruppin Academic Center, and a B.A. in Geography and Environment from Haifa University, Israel.
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Doctor of Medicine, the Hebrew University and Hadassah Hospital in Jerusalem. 1985 completed his residency in psychiatry at the Shalvata Mental Health Center (Hod Hasharon) affiliated to Tel Aviv University. Kotler was one of the founders of the military mental health department , in the years 1985-1989 served as its head (at the rank of lieutenant colonel in the reserves). Research fellow in biological psychiatry and psychopharmacology at the Albert Einstein School of Medicine of Yeshiva University in New York for two years. 1991, director of the psychiatric department at Beth Israel Hospital in Newark, New Jersey. 1993, returned to Israel and was appointed director of the system at Ben-Gurion University of the Negev, and in 2000, deputy dean for teaching at the faculty. At the same time, he graduated with a master‘s degree in health systems management.
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Founder of Cannadorf. He has over 10 years of academic, industrial research and management experience, in the fields of microbiology, molecular biology, plant sciences, diagnostics, and medical devices. He also has extensive background in regulation, business development and commercialization of science-based products. Kobi holds a B.Sc. in Horticulture and Plant Protection (Summa Cum Laude), M.Sc. in plant genetics and breeding (Summa Cum Laude) both from The Hebrew University of Jerusalem, an M.A. in Business Administration from the College of Management, and a Ph.D. from the Hebrew University of Jerusalem.
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Fermentation and tech. transfer expert, with over 10 years of industry and academic experience. Liron served in pharmaceutical companies in different positions, bringing to the table vast experiments in management and research. Her expertise are drug developing, protein fermentation & purification, biology assays, and manufacturing. She also holds QC and QA knowledge and a Ph.D. in Molecular Biology from the Weizmann institute of science.
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Since 2006, Maggie is the head of a laboratory in the Department of Plant Pathology and Microbiology at the Hebrew University of Jerusalem. The research activities in Maggie‘s laboratory combine basic and applied research focusing on plant-pathogen interactions and plant immunity. She is also an expert in plant secondary metabolites and studies their effect on fungal pathogens. So far, Prof. Maggie Levy has won highly competitive research grants and published an impressive number of articles in leading professional journals.
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Has over 15 years of academic experience in the field of neuroscience and over 10 years of industrial experience at a medical device company (BrainsWay) that targets psychiatric conditions. He planned and managed both preclinical and clinical experiments and has vast experience in the a priori scientific literature reviews, in analyzing and interpreting results, and in their communication to different audiences. Noam holds a B. Tech in Biotechnology Engineering from the Ort Braude College, an M.Sc. in Life Sciences from the Bar-Ilan University (in cooperation with the Weizmann institute), and a Ph.D. from the Ben-Gurion University.
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A senior researcher within the chemical industry with over 8 years of industry experience. Prior to PsyRX, Jonathan served as a senior phytochemist in Synergio, organic chemistry researcher in Chemada Fine Chemicals and formulation chemist in S.A.N advanced protection systems, where he led several point-of-care product developments from bench to market. He holds a Ph.D. in Organic chemistry from the Weizmann institute of science.
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