Hi there fellow ZLD holders,
Just wanted to share a Q & A exchange I've had this week with Richard Hopkins at Zelira.
I think you'll all enjoy these paragaphs in particular:"The first half of 2020 will see products launched for Autism (HOPE), Aged Care and, fingers crossed, Insomnia. We also expect to commence a clinical trial for Autism using formulations aligned to our HOPE range of products
The second half of 2020 will see clinical trials launched for Targeted Pain and Targeted Gastro-intestinal disorders. In addition, we expect to launch new revenue-generating products for Dermatology and Oral Health Care."
We are in for an exciting, busy, transformational year.
I'm very happy to own a piece of this company.Email Q& A with Richard Hopkins of Zelira Therapeutics – 10/01/2020
Q: ZLD'strial sizes seem relatively small which is great for money management andconformation, but does this mean that additional trial iterations will berequired before heading into a phase 3 trial? Maybe describe the next steps forthe insomnia clinical trials if they were to be successful, for instance.
Two independent statistical evaluations have confirmed the trial design is sufficiently powered to achieve statistically meaningful outcomes. Demonstrating you can achieve statistical significance is a key requirement for an ethics committee before they will grant approval for a trial.
If the results of the trial are successful, there will be no need to repeat the Phase 2 Insomnia study and we can proceed to Phase 3.
Q: Are we going into phase3 with the insomnia research if the cost/benefits weigh out?
A positive outcome to the trial will result in Zelira owning the worlds first clinically validated full spectrum medicinal cannabis product for Insomnia. This will unlock significant value, provide a clear point of differentiation and create a number of commercialisation opportunities.
The immediate priority will be to rapidly commercialise the Insomnia formulation in global markets for unregistered medicinal cannabis products. Here the strategic benefits of the recent Ilera merger will be highlighted as we’ll have premium access to the US, the worlds largest medicinal cannabis market with over 4 million registered patients, many of whom are impacted by Insomnia.
A successful outcome to the trial will also facilitate the path to a Phase III trial and ultimately product registration. This will further differentiate Zelira from its peers and ensure the company is well positioned to maintain its leading position as the market become increasingly regulated.
Q:Will the company be going down the FDA path at all in the near term? And if so,isn’t their an end of phase 2 meeting that will need to take place in the nearfuture. Has this been scheduled?
From the outset, Zelira’s strategy has been to undertake clinical trials to a standard that would be accepted by the FDA. As per the FDA guidelines our data-packs will include the requisite safety and efficacy data. The ability to include ‘real-world data collected from patients via our “Launch Learn and Develop’ strategy, will further enhance the data-pack. Notably, the FDA is increasingly recognising the value of ‘real-world’ patient data as an important complement to data generated from traditional clinical trials.
Q:How would you articulate the difference between the TGA/FDA pathways, and willyou be going the TGA path for phase 3?
Longer term, we will be looking to register our products in all major markets including those covered by the FDA and TGA. Clinical trials undertaken in Australia are recognised by most global regulatory bodies, which means they don't need to be repeated to register products in different jurisdictions. As long as we comply with all relevant FDA regulations, the US will accept data from foreign clinical trials.
Q:Can you please elaborate more about your vision for clinical trials and thelaunch learn develop model?
Our unique Launch, Learn and Develop model provides a number of strategic advantages.
First, it allows us to immediately generate revenues by launching products into global markets.
Second, it enables us to learn about the our products by generating ‘real-world’ data collected from patients.
Third, real-world information relating to the safety and efficacy of our products can be used to inform and de-risk the design of our clinical trials. This strategy significantly improves our chances of success and accelerates the process of drug development and registration.
Q: Why have ZLD not beensupplying their oils for the last 3 years through the special access scheme?
Zelda’s initial strategy was to generate clinically-validated data from its clinical trial before launching the products into the market. Following the recent merger, Zelira will accelerate its Launch, Learn and Develop model to rapidly commercialise a portfolio of products into global markets. In addition to HOPE, which has already launched in the US, we will follow-up with products for aged care, dermatology and oral-health care where the barriers for market entry are relatively low.
Q: What was the honest reason for the drawn out process ofadministering oil to circa 30 patients over a few weeks for the insomnia trial?
The complex process involved in patient recruitment, screening, selection and then dosing reflects the stringent design of our clinical trial. By do doing we have minimised the risk of bias and maximise the quality of the data.
Q
oes the company intend to launch clinical trials into new research areas in2020, as suggested by the most recent investor presentation/slideshow (IEDermatology, Aged Disorder, Targeted Pain, Crohn's)? Could you please give anindication as to what quarter this/these can be expected to launch?
The first half of 2020 will see products launched for Autism (HOPE), Aged Care and, fingers crossed, Insomnia. We also expect to commence a clinical trial for Autism using formulations aligned to our HOPE range of products
The second half of 2020 will see clinical trials launched for Targeted Pain and Targeted Gastro-intestinal disorders. In addition, we expect to launch new revenue-generating products for Dermatology and Oral Health Care.
As you can see, it’s going to be busy year.
Q: It'sbeen a little while since we've had an update on the cancer pre-clinicalresearch. Could you please give an indication as to what quarter this can beexpected in 2020?
With the recent merger and the focus on clinical trials and product launches we have deliberately kept the focus away from our preclinical cancer research projects so as not to distract the market. We expect to provide a comprehensive update on all our ongoing preclinical projects with the first half of 2020.
