Q&A

OCT is a biopharmaceutical company harnessing the therapeutic power of cannabinoids. We are developing prescription medicines through a regulatory pathway, with a particular emphasis on targeting chronic neuropathic pain. These are debilitating conditions where people may find themselves addicted to opioids, experiencing severe side effects or find their treatments don’t work anymore. It is a market valued at nearly US$60bn and expected to rise to US$75bn by 2027. Our aim is to develop non-addictive cannabinoid based medicines to meet this huge need. We have four active programmes currently in development. In addition, having established an exclusive license agreement with Canopy Growth Corporation for their entire pharmaceutical cannabinoid derivative library, we also have a portfolio of around 500 derivatives and intellectual property rights including 14 patent families and associated research data. We have a clearly defined path to commercialisation, revenues and growth. We are developing drug candidates through clinical trials to gain regulatory approval (FDA/MHRA/EMA) that will enable medical professionals to prescribe them with confidence. Our portfolio aims to balance risk, value and time to market, whilst ensuring market exclusivity around all our key activities.

As a biopharmaceutical company there are important differences between us and a medical cannabis company and what we do.

First is that we are developing medicines to be prescribed by doctors and not oils or creams that you can buy in a health food store without prescription.

Medical cannabis companies can only work with the flower or extract of cannabis and harness what properties it may have naturally. As a biopharmaceutical company we can do this too but we can also chemically change and improve the structure of cannabinoids to target specific diseases and ensure market exclusivity for our medicines. Our aim is 1) to target those chronic neuropathic pain conditions, where patients continue to live with pain which is unresolved or resistant to current treatments and 2) to have market exclusivity in these indications.

Unlike medical cannabis company products, all our medicines will be tested through robust clinical trials and approved by national medicines regulators, such as the FDA (USA), EMA (EU) or MHRA (UK). By doing this, we can make evidence-based efficacy and safety claims about our medicines, which will target specific indications. Importantly doctors will be able to prescribe our medicines rather than people having to pay out of their own pocket. For countries with an insurance-based healthcare system, such as the US, the health insurance companies will be able to reimburse our medicines making them more accessible to many people suffering from chronic pain

Humans have been using cannabinoids for many years to treat a variety of ailments, including pain.

With this wealth of understanding on cannabinoids available we have been able to carefully select four programmes for development, in the knowledge that we can:

• Harness this understanding and reduce development risks and costs

• Deliver medicines that will be first in class or uniquely positioned in the market

• Target pain conditions that remain unresolved and resistant to current treatments

The global pain market is valued at US$59.5 billion.

As a biopharmaceutical company, we are following the rigorous regulatory process set out by national medicines regulatory agencies around the world such as the FDA (USA), MHRA (UK) and EMA (EU).

In all cases we have an ongoing dialogue with the regulatory agency to ensure that our medicines meet their strict criteria for safety and efficacy. As part of this, each medicine will go through sequential steps before being approved for use with people. After each step a thorough and independent review of the data collected is completed before starting the next step.

Pre-clinical trials – These are studies in test tubes and animals to provide data on the safety and efficacy of the trial medicine.

Phase I clinical trial – This is the first study in a small number of humans and primarily provides information on the safety and tolerability of the medicine to allow it to be tested more widely. The people involved in this study are what are known as ‘healthy volunteers’. Phase I only needs to be completed once even if a medicine is being considered for different indications.

Phase II clinical trial – There are different types of Phase II clinical trials. These are the first studies in people with the condition that a medicine is aiming to treat / prevent or diagnose. Primarily researchers will be gathering information on the safety and efficacy of the medicine in people with the particular condition e.g. what dose of the medicine to use to elicit a therapeutic response from the patient.

Phase III clinical trial – This is the largest trial of the three phases and, like Phase II, studies people with the specific condition. The Phase II study will have provided important information for the Phase III study on the appropriate dosing and treatment regimen to be used. People in the Phase III study will either be assigned to a group receiving the trial medicine or to a placebo group. The process of assigning people is usually done randomly and without the person knowing which group they are in. This is what is known as a Randomised Controlled Trial (RCT). Primarily Phase III studies aim to demonstrate whether or not a medicine offers a treatment benefit to a specific group of patients and to provide more detailed safety data.

Application for licence – Once the trials are completed, a Licence Application is completed and submitted to the regulatory agency for consideration.

Approval and Use – Once approved, regulatory authorities will grant a licence for a medicine defining its indication and terms of how it should be prescribed.