Re-Purposed Formulations Offer Accelerated Approval Opportunities

NanaCannabinoids: The Major Contender for Future Blockbuster Solutions

SGN NanaoPharma is committed to developing novel therapies and re-purposing existing approved drugs to treat serious illnesses—a careful and significant process.

One of the most important steps in the approval process is the clinical trial where regulated studies are conducted with individuals who volunteer for personal observations utilizing experimental therapies.

Our current pipeline of re-purposed products targets an accelerated advantage specific to the regulatory pathway they are subject to. In the USA the 505 (b)(2) regulatory pathway is predicated on the inherent safety record of all ingredients along with the established safety & efficacy of the candidate drug. Therefore, Phase I safety studies are not required, and the regulatory path typically consists of conducting a Phase II “Pilot” safety & efficacy study followed by a “Pivotal” Phase III study. These clinical studies are significantly less arduous than Phase II & III standards as required for a novel therapeutic. This particular investigatory approach can thereby save considerable time and cost to complete, without reducing the overall level of quality standards.

Based on our advantageous and proven methodology, SGN has developed several formulations that are stable and differentiated in pre-clinical models from their non-nano, currently marketed counterparts. From this pool of pre-clinically differentiated MNP formulations, we have initiated one Phase II clinical trial and expect to initiate an additional 2-4 Phase II clinical studies in 2020/2021.

Cannabinoid safety is currently subject to extensive and ongoing investigation by a growing number of researchers and institutions. As such, nanocannabinoid molecules are still subject to traditional Phase I, Phase II, and Phase III  studies. After obtaining the requisite DEA approvals, we have aggressively advanced initial formulation development in this area with the strategic aim of filing Investigational New Drug  (IND) applications and initiating clinical studies shortly thereafter in 2020. As additional safety research data becomes available in the near future, the classification for at least some cannabinoid ingredient safety may shift and align across our entire pipeline of candidate products, thereby accelerating our development timelines and positioning SGN as a leader in the development of NanoCannabinoid drugs and their potential blockbuster rewards.

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