Understanding the Trial Process

Merger or acquisition investment

As many of you may know, PKA SoftTouch Corp. (PKA) raised enough capital last year to fund veterinary trials. This year, we are raising further funds for human clinical trials, which should be the final stage before commercialization and the ability to sell licences of our Micro-needle technology.

PKA’s leaders are very experienced at successfully running health-tech trials. Dick Crawford, our CEO, and co-founder, has 50 years of experience working in the pharmaceutical industry, 20 of which were in the US, and is very familiar with US FDA regulations. Dr. Modi, our co-founder, has successfully completed hundreds of these trials for previous healthcare commercialization and applies an in-depth knowledge and understanding of Health Canada regulations and FDA regulations.

Why do we need testing?

The Micro-needle is a health-tech device that penetrates the skin, not too deep that it causes pain, and needs to be tested to ensure efficacy and successful delivery of the drug; at least as good as the gold standard used in the industry – the syringe. All health-tech devices must go through specific testing before going to Health Canada for approval. Health Canada requires that the research and development be fully recorded.

As with most health-tech, our Micro-needle was developed and optimized in a lab. We are currently undertaking veterinary testing with a 3D printed device based on regulations and protocols for animals. We are confident that our technology will pass testing for safety and effectiveness based on previously successful results. Although veterinary clinical trials are a requirement, we’re fortunate that the Micro-needle has a massive opportunity for pain-free delivery for the animal market.  That being so, once we have completed the veterinary testing, we can work with animal drug manufacturers to licence the Micro-needle for their drugs and generate a preliminary revenue stream.

The final stage, human testing, is scheduled for 2022. We’re planning to ensure the Micro-needle will meet Health Canada regulations, US FDA regulations, and European Directorate regulations. We have met with and confirmed a clinical trial site in Ontario, and are preparing for a two-day insulin trial, which will be the drug used to measure the effect on the body.

Dick Crawford, BSc., P.Eng., P.E. Chief Executive Officer

We’re trialling the device, not the medication

Trials for a new drug can cost $100 million and take ten years. For medical devices, we only need the efficacy of the device approved. This is called ‘Proof of Concept’, which is why our veterinary trial costs were under $500,000.

We’ve had our testing protocol signed off. We’ve been optimizing the Micro-needle using 3D printed parts. Now, we are developing the moulds to get the final design of the parts made.

We’ve hired New Current Inc., as our mechanical engineer, to support us in developing the Standard Operating Procedures to meet Health Canada’s requirements. New Current has assisted us with the development of the Micro-needle device, to be approved by Health Canada.

Human trials

As we mentioned, we don’t need to test the drug, just the delivery of the drug in humans. Our work to date has suggested it will be as good or better than a syringe. Dr. Modi will develop very detailed protocols for the trials that will need to be approved by Health Canada. It can take several months as Health Canada often has a lot of questions. The trial itself usually takes two days, but the preparation for the process, as you can see, may take many months. We may test ten people with a syringe and ten people with the Micro-needle, and then on the second day, we swap the Micro-needle device and the syringe. The syringe has been around for 170 years and is used by 80% of the industry. We will send the results to Health Canada, who will review the data. At the end, we will obtain approval saying we can proceed.

Licensing the Micro-needle

Animal drug companies require Proof of Concept clinical trials approved by the Canadian Council of Animal Care and human drug companies are looking for that Proof of Concept approved by Health Canada.

By licensing the Micro-needle to drug companies, we are not responsible for the drugs, just the transfer of technology, which will streamline the process. First, the companies will require the compatibility studies of their drug in our Micro-needle, so that there is no interaction between the drug membrane and vice versa.

The second part of the study is a short and/or long-term stability study that their drug is maintained in the Micro-needle. This study will usually determine the expiry date for the drug in the Micro-needle. We do this with the potential licensee using heat and humidity to speed up testing from a couple of years to a few months. Once testing is complete, the licensee completes the licensing agreement and starts production. Drug companies will take responsibility for the Micro-needle, and PKA will receive a 3-5% royalty for each device made.

We know that some smaller drug companies do not want to manufacture their own Micro-needle devices. Thus, we may work with 3rd party contractors who can make them on their behalf.

So, where are we now?

We’re nearing the end of the first veterinary trial process. The protocols have been written, approved and ready to go. We are testing the device for its efficacy, safety and drug’s effectiveness compared to a syringe. The final part of the trial is to be accomplished soon.

PKA is a leading-edge research and development company based in Lakefield, Ontario. Our med-tech company was founded to bring its unique and revolutionary device to the growing worldwide injectable drug marketplace. To find out how you can buy shares and become a part-owner of this exciting new venture.

Please visit our FrontFundr equity crowdfunding raise at https://www.frontfundr.com/pkasofttouch