PsyRx

PsyRx is developing an innovative treatment for one of the most common illnesses worldwide – depression. Our drug combines an FDA-approved SSRI with a low dose of Ibogaine – a stimulant with a unique mechanism of action that has been researched and shown to significantly impact depression. Our approach aims to shorten the time to therapeutic effect, reduce side effects, and improve the quality of life for patients.

Patents, cooperation, and a strong scientific team

PsyRx has filed a unique patent application protecting the combination of Ibogaine with existing medications for the treatment of depression. The patent has already been granted in South Africa, and the application is undergoing approval processes in additional countries worldwide.

Scientific Collaborations
The company is engaged in groundbreaking research collaboration with leading researchers from the Hebrew University, who are assisting in the development of advanced production methods for rare active pharmaceutical ingredients.

Leading Scientific Team
The company's team includes top professionals, such as Prof. Itamar Grotto, former Deputy Director-General of Israel’s Ministry of Health; Nobel Laureate in Chemistry, Prof. Aaron Ciechanover, who serves on the company’s Scientific Advisory Board; and Prof. Moshe Kotler, former Director of the Mental Health Centers in Be’er Ya’akov.

Support and Investments
To date, the company has raised several million shekels from private investors and from the U.S.-based investment fund TRIPPY.VC. The fund was founded by Rohan Marley (son of Bob Marley) and NBA star Amar’e Stoudemire. These investments have been utilized for patent registration, the development of advanced manufacturing methods, and the completion of successful preclinical trials.

Update 1: In a study conducted by Stanford University and published in "Nature" magazine (January 2024), it was found that Ibogaine is effective for head injuries and post-traumatic stress disorder (PTSD). The study showed that a single use resulted in an improvement of over 80% in PTSD symptoms (!) such as in depression and anxiety symptoms, the results were statistically significant and the improvement occurred in a very short time period.

Update 2: PsyRx has successfully completed the pre-clinical safety trials of the drug combination - this is a mandatory requirement of the Ministry of Health and a significant milestone towards continued development.

Update 3: PsyRx has completed development of the technical file for Ibogaine manufacturing  - putting PsyRx as one of the only companies in the world that can produce pharma-grade Ibogaine for human use. Ibogaine trading can be a significant revenue stream for PsyRx in the pharmaceutical industry.

Update 4: PsyRx has recently obtained a research license from the Ministry of Health to conduct a preclinical efficacy study of the combination drug.

Depression – The Epidemic of the 21st Century

The field of mental health, and depression in particular, is facing a global crisis. One in four people will suffer from depression at some point in their lives. The COVID-19 pandemic exacerbated this issue, leading to a sharp rise in depression cases worldwide. According to the World Health Organization, by 2030, the economic cost of depression and other mental illnesses is projected to reach $6 trillion – an enormous financial burden on nations.

Traumatic Events Amplify the Crisis
Global and local events, such as the COVID-19 pandemic and the October 7th events in Israel, act as catalysts for a dramatic increase in the use of antidepressants and in depression cases overall.

Gaps in Existing Treatment
Despite the vast scale of the problem, depression treatment remains inadequate:

• 71% of people suffering from depression receive no treatment at all.
• 35%-40% of patients treated with SSRIs do not respond to the treatment and are diagnosed with treatment-resistant depression.
• Existing medications take weeks to show effects and are associated with significant side effects, including weight gain, decreased libido, sleep disturbances, and, in some cases, worsening suicidal thoughts.

PsyRx at the Knesset's drug and Narcotics Committee.Aid to the victims of October 7

PsyRx – Leading the Fight Against Depression
At PsyRx, we are committed to spearheading the fight against depression with innovative solutions. We are developing a groundbreaking drug that combines Ibogaine – a psychoactive compound derived from the roots of the African Iboga plant – with Citalopram, an FDA-approved SSRI antidepressant.

PsyRx - Nice to Treat

PsyRx is developing a breakthrough therapeutic concept, based on a new drug that will combine Ibogaine, a miraculous plant that has received research recognition, and an existing drug for depression already approved by the FDA. Ibogaine is a psychoactive mind-altering substance, found in the roots of the African plant Iboga. Ibogaine has been proven to be effective for the treatment of mental symptoms related to depression and post-traumatic stress disorder. Based on studies that have already been carried out around the world, it is suggested that the combination of ibogaine with existing drugs can have a positive and rapid effect within a few days of the onset of the drug's effect. This change is dramatic compared to traditional drugs, whose effect only begins later after a couple of weeks. In addition, the drugs on the market have severe side effects, which cause many patients to stop the treatment - leading to poor compliance. . Using an ibogaine-based drug may significantly reduce these side effects, thus allowing the patient to continue taking the drug without compromising the treatment sequence. The development of the drug is conducted in accordance with the guidelines of the Ministry of Health and the FDA and by leading scientists and experts from the top of academia and the Pharma industry!

Simultaneously with the drug development, PsyRx has developed innovative methods for production, extraction, and purification of psychoactive molecules, based on botanical sources such as ibogaine, derived from the Voacanga Africana plant.

PsyRx employs integrated agro-medical methods and bioreactor technology to produce substances that can be used for the development of antidepressant medication and other drugs based on psycho-active compounds, currently in various stages of development in the pharmaceutical industry.

These are valuable and rare raw materials sought after by the pharmaceutical industry. Their production capacity may provide PsyRx with significant additional revenue streams alongside the antidepressant drug development.

The company boasts experienced management and a high-quality scientific staff.

The founders of the company have a rich and successful experience in establishing new companies, launching products in the life sciences arena, and IPO's in the stock exchanges. The company's scientific team consists of leading experts in biotechnology, drug development, and business development.

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 MD specializing in public health and a professor of epidemiology, who served at the Associate Director of the Israeli Ministry of Health and was a member of the executive committee of the World Health Organization (WHO).

Dr. Gil Ben-Menachem, CEO, has over 25 years' experience in drug development and biotechnology entrepreneurship. Dr. Ben-Menachem has held executive roles at leading pharmaceutical companies, including Teva and Dexcel.

Prof. Moshe Kotler MD , psychiatrists, 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.

PsyRx Market Overview

According to recent  estimates, approximately 26% of Americans aged 18 and older suffer from a mental disorder in a given year, and around 17.3 million adults in the United States experience at least one major depressive episode during their lifetime. Additionally, about 40 million adults in the United States suffer  from anxiety disorders. This phenomenon is also widespread in the UK. According to the UK Office for National Statistics, one in every six people is affected by depression. These numbers are expected to increase due to the side effects of the global coronavirus pandemic, as reported by various organizations and institutions.

Moreover, unhealthy eating habits, demanding work schedules, increased isolation from family and loved ones against the backdrop of technological advancements, and the inability to adapt to the rapidly advancing pace of the world - all contribute to the increase in various psychiatric symptoms in general - particularly anxiety and depression.

The promising results from studies on consciousness-altering substances (psychoactive) have increased their use across the United States and in other regions, leading to a growing demand in many countries. Although the industry using these substances is still in its infancy and the companies traded in it are only at the beginning of their journey, there are very significant capital flows into the market, with hundreds of millions of dollars in investments flowing between October 2020 and January 2021.

So far, major pharmaceutical companies have not invested in psychoactive substances due to various regulatory issues. However, now, due to regulatory ease (FDA in the United States and EMEA in Europe), large pharmaceutical companies are beginning to invest, and are expected to increase their investments and incorporate psychoactive substances into their drug pipelines.

Company's Market Position:

PsyRx is the only company offering a combination of an approved SSRI family drug combined  with a psychoactive substance as a prescription medication.

The company targets the global mental health market, not just the psychedelics market.

Development of production, extraction, and purification systems for molecules from biological sources.

Offers sale of Active Pharmaceutical Ingredients (API) + third-party sales/licensing.

PsyRx aims to become the largest player in this field due to its cutting-edge technology.

Our Technology

PsyRx's technology for producing semi-synthetic ibogaine is based on Voacanga Africana plant as source material. Our methods allows for significantly lower production costs compared to existing production methods today.

The quality of production under appropriate conditions and the production of ibogaine is a prerequisites for any drug development, adding the challenge of producing this plant-derived substance. Currently, psychoactive substances of botanical origin are produced using traditional agricultural methods, which have drawbacks including concerns about contamination, pesticide use, radiation, and active compound variations.

Today, it is almost impossible to find in the market ibogaine from botanical sources that is produced under appropriate manufacturing conditions required for human use. Therefore, the vast majority of current research and development in the field is based on synthetic molecules that differ in some properties from the original plant material.

Additionally, there is a demand in the market from pharmaceutical companies, mental health clinics, and research centers for an active substance from botanical sources, which is produced under appropriate conditions, high quality, and in a uniform manner.

PsyRx's developed technology allows for the production of ibogaine (as an active substance) API from the root bark of the Voacanga Africana plant.

PsyRx has developed a precise process conducted in a controlled environment, ensuring the production of molecules of high quality, maximum speed, and significantly higher efficiency compared to conventional production methods. Since the development takes place under appropriate manufacturing conditions and full compliance with GMP and stringent regulatory requirements, the company can produce a large quantity of material at relatively low economic costs. This enables PsyRx to sell the material to pharmaceutical companies, research and development facilities, or develop drugs themselves at an affordable price with high profit margins.

Unique Patents and Investments in the Company

PsyRx is on its way to achieving strong intellectual property, covering the combination of ibogaine with antidepressant drugs.

PsyRx collaborates with one of the leading patent law firms in Israel, specializing in patent registration and protection. The strong IP base is expected to provide a significant barrier against potential competitors. In 2021, the company filed its first patent for the combination of ibogaine with SSRIs for the treatment of depression. Currently, the company is conducting efficacy research in animals to strengthen the patent claims.

This patent has already been granted in South Africa, providing the company with a significant competitive advantage.

PsyRx's progress doesn't happen in a vacuum; the company has already raised millions of shekels from a group of private investors in 3 funding rounds, opening the door for its developments, achievements, and successes.

One of the investors in the company is the American NFT fund TRIPPY.VC, whose founders include Rohan Marley (son of Bob Marley) and NBA star Amar'e Stoudemire.

Research Collaborations

The company has a collaboration agreement with the Hebrew University of Jerusalem (Faculty of Agricultural, Food and Environmental Quality Sciences), which includes:

1) Development of methods for extraction, separation, purification of botanical material and conversion into an active pharmaceutical ingredient (API) for commercial production for various uses, such as: pharmaceutical industry for drug development, clinical research, hospitals, and mental health clinics, among others.

2) Development of a method for ibogaine production.

The developments are carried out in university laboratories in full cooperation.

PsyRx has completed a preclinical safety trial and is working on a protocol for human research.

Why Ibogaine?

Not just ibogaine: Consciousness-expanding substances have been available for therapeutic and mental health treatment since ancient times. However, in the last 50 years, they have been pushed to the sidelines mainly due to various political reasons.

In recent years, there has been a significant increase in research on these substances, which consistently show their enormous potential for treating a variety of health conditions. For example, clinical trials have shown that MDMA is highly effective in treating Post-Traumatic Stress Disorder (PTSD). Ketamine (originally an anesthetic) effectively treats depression and suicidal tendencies — in Israel, the Ministry of Health approved a depression drug with ketamine components in 2020, which also entered the drug health  basket  (entitled top reimbursment)

Ibogaine is effective in treating substance addictions, alongside depression and anxiety treatment. The treatment usually involves short-term administration of high doses, which cause psychoactive effects and therefore require close integration and monitoring by professionals in a controlled clinical environment.

However, there are many indications that these substances can be used in low doses (Microdosing) that do not cause psychedelic effects, in order to alleviate psychiatric/psychological symptoms and improve the quality of life of patients.

Several studies in addiction research have demonstrated the effectiveness of ibogaine and noribogaine (a secondary metabolite of ibogaine) in reducing the search for various addictive substances such as heroin, cocaine, morphine, methamphetamine, nicotine, and alcohol. The data also indicate their effectiveness in influencing psychological symptoms related to depression and trauma. Research in this field is growing, and recently a clinical trial was approved providing ibogaine for opioid withdrawal.

In a recent study conducted by Stanford University and published in the journal "Nature Medicine ", ibogaine was found to be an effective treatment for head injury and post-traumatic stress disorder (PTSD) victims. The study was conducted on 30 American combatants suffering from PTSD and brain damage from explosions and blasts. The study showed that ibogaine use significantly reduced or completely eliminated some of the severe symptoms of PTSD, including depression, anxiety, intrusive thoughts, paranoia, hyperarousal, outbursts of anger, guilt, detachment, sleep problems, and more. The astonishing thing is that a single use of ibogaine led to an improvement of over 80% in PTSD symptoms, as well as depression and anxiety symptoms.

The results were statistically significant, and improvement occurred in a short response time of days to months.

PsyRx is one of the few companies in the world holding a technical dossier to produce ibogaine at a pharmaceutical level, meaning a drug substance suitable for human use. The company is in advanced stages towards commercialization and production of ibogaine with the intention to start marketing the substance to medical institutions and laboratories worldwide.

This production is expected to be a significant source of income for the company!

Business Model

The company's business model consists of the following elements:

1. Sales of a new antidepressant drug.
2. Signing licensing agreements for the manufacturing and marketing of psychiatric drugs. The company plans to combine existing drugs with ibogaine to enhance efficacy and reduce side effects.
3. Sales of active pharmaceutical ingredients (APIs) of psilocybin and ibogaine for research and drug development purposes.
4. Sale of technology usage rights through sublicense or tech transfer (in bioreactors) to third parties in exchange for royalties.
5. The company plans to establish joint ventures with companies developing drugs based on ibogaine for various indications. Initially, the company will produce API substances that will be sold to potential customers such as commercial companies and research institutions for experiments and medical developments.

Regulatory Pathway for Drug Development

PsyRx is focusing on the research and development of an innovative Combination Therapy regimen using ibogaine HCL in microdose, aimed at treating patients suffering from severe Major Depressive Disorder (MDD) who do not improve or show only partial response to existing antidepressant treatments. These treatments are mostly based on Selective Serotonin Reuptake Inhibitors (SSRIs) and therefore suffer from "treatment-resistant depression".

The company is currently establishing its intellectual property through various trials, which are required to demonstrate the safety and efficacy of the treatment and will allow it to begin the first clinical trial in humans in Israel, which will demonstrate the success of the combination treatment.

Currently, the company is working on a pre-clinical efficacy trial to demonstrate the effectiveness of the combination therapy.

Based on vital information derived from the human trial, the company will submit a Pre-IND meeting request to the U.S. Food and Drug Administration (FDA), for the purpose of further development and to assess the feasibility of conducting the required research in patients in the United States. Regulatory submission in the United States will be based on the 505(b)(1) pathway, based on the results of the initial clinical trial indicating the combined therapy's ability to address an "unmet medical need" in the treatment of a severe or life-threatening condition. Additionally, the company will seek recognition for development in a fast track designation or breakthrough therapy designation – pathways that expedite regulatory approval for drug use.

PsyRx in the media

• The offer is not subject to the securities laws and corporate laws applicable to a company offering securities to the public. The Israel Securities Authority has not approved the publication of this offer document and has not reviewed it. Following the completion of the offer, the company will not be subject to disclosure requirements and corporate governance provisions designed to protect its investors and provide oversight by the Israel Securities Authority.