6 Clinical Programs, 1 Primary Goal – Alleviate Human Suffering.
To achieve our goals, we intend to:
Advance our novel investigational drug candidates towards approval in the United States and elsewhere.
We are pursuing FDA approval of all our drug candidates currently in development. All preclinical and clinical trials are structured to ensure that each program is FDA compliant. We will be pursuing a New Drug Application (“NDA”) with the FDA with respect to each of our drug candidates. If the NDA is approved, the product may be marketed in the United States. Once an NDA for one of our drug candidates is approved in the United States, we plan to pursue marketing approval of our drug candidates in other regions including Europe, Japan, Australia and Israel.
Take advantage of accelerated commercialization pathway options for our drug candidates.
We and our regulatory consultants believe that each of our drug candidates will qualify for one or more FDA expedited review programs (breakthrough designation, accelerated approval, priority review and/or fast track), as there are limited pharmaceutical treatments approved in the U.S. for the indications that we are targeting with our drug candidates, and the pharmaceutical treatments that do exist have limited efficacy and/or are expensive. These expedited review programs often result in accelerated and less-costly pathways to approval compared with traditional regulatory pathways.
Develop future clinical products targeting unmet medical needs.
We intend to develop clinical products that treat unmet medical conditions or conditions where current treatment options are limited. As a result, we may have opportunities to accelerate commercialization of such products.
Maintain a strong intellectual property portfolio.
We have developed a global intellectual property strategy to support our commercial objectives. We are monitoring the results of our research and development programs to identify new intellectual property that aligns with those commercial objectives. We intend to take a global approach to our intellectual property strategy and we intend to pursue patent protection in key global markets, including the United States, Europe, Japan and Israel.
We have pending patent applications relating to our drug candidates IHL-42X, IHL-216A and IHL-675A.
Unique value proposition
- Diversified strategy – 6 x drug development programs.
- The first ASX listed company to investigate psychedelics in combination with psychotherapy.
- Multiple income streams – immediate revenue via SAS sales and also from future drug sales post-registration.
- Expedited FDA registration strategy to shorten time to commercialisation.
- Strong cash position and fully funded for Phase 2 clinical trials.
- Strong patent portfolio.
- Positive preclinical results across multiple programs.
- Five novel cannabinoid programs and one psychedelic innovative research program underway.
- Total addressable market of each therapeutic area> $1 billion.
- Global export potential.
- Established research evidence supporting hypothesis for benefit of cannabinoid in the chosen therapeutic area.
- A variety of near-term catalysts resulting from an extensive, multi-pronged research program including, in vitro and in vivo non clinical studies, patent filings, randomised clinical trials and open label studies, etc.
- Accelerated commercialisation pathways remain available (e.g. early sales under Australian Special Access Scheme prescribed by willing doctors prior to full product registration).
- Currently, patients have significant unmet medical needs, improving the probability that a drug discovery will be eligible for public subsidies (e.g. PBS in Australia).
Stay up to date with Incannex’s research and development program.