Ethicann’s business strategy is to leverage its unique formulation and regulatory strategies, developed for the lead MS Spasticity product, to enable launch of four pipeline products into markets worth collectively more than USD $20B (2025 company estimate) – all by 2032. In particular, EPI-004 represent a submarket of a gigantic market (chronic pain in general), while EPI-005 and EPI-006 addressing significant, but severely underserved markets:
- EPI-003: Chemotherapy-Induced Nausea and Vomiting (CINV)
- EPI-004: Chronic pain from cancer
- EPI-005: Post-traumatic stress disorder (PTSD)
- EPI-006: Opioid Use Disorder (OUD)
- CBD-only Zydis ODT formulation (for dose optimization of all pipeline products)
Of unique and particular interest is the notion that patients may be able to ultimately “self-dose” with a CBD-only Zydis ODT, to improve performance of EPI-003 through EPI-006 – see description below. The development timeline, including initial regulatory pathway, is outlined in the table immediately below. The products in this table are referred to as “First Generation Products” – meaning products that can be rapidly moved into various markets with effective execution by Ethicann.
Pipeline & Development Timeline for First Generation Products
|EPI-003||b-THC + s/b-CBD||CINV||Phase 2/3-505(b)(2)||Zydis ODT||2024-28||Q2-2029|
|EPI-004||b-THC + s/b-CBD||Chronic Pain||Phase 2/3-505(b)(2)||Zydis ODT||2026-29||Q1-2030|
|EPI-005||b-THC + s/b-CBD||PTSD / US Army||Phase 2/3-505(b)(2)||Zydis ODT||2026-29||2031|
|EPI-006||b-THC + s/b-CBD||Opioid Use Disorder||Phase 2/3-505(b)(2)||Zydis ODT||2027-30||2032|
|CBD-only||s/b-CBD||All pipeline products||Phase 2/3-505(b)(2)||Zydis ODT||2023-25||As Appropriate|
b = botanical s = synthetic s/b = botanical or synthetic ODT = oral disintegrating tablet
1Developmental timeline – all US products will use the 505(b)(2) pathway, involving a Phase 2 to optimize dosage – all Canadian products will use the SRTD/NDS pathway, relying on a bioequivalence study
2Launch dates are good faith estimates, which may be affected by issues including without limitation supply sources, development, clinical studies, mfg costs, regulatory approvals, delays and the coronavirus pandemic.
Pipeline Drug Products and Regulatory Strategy Summary
EPI-003 represents an advanced formulation of the EPI-001 product for the treatment of chemotherapy-induced nausea and vomiting (CINV). Ethicann plans to deploy a delivery system using the Zydis utilizing a Zydis THC/CBD ODT formulation already developed by Catalent for Ethicann – that will have clinical and safety benefits in treating CINV. In contrast, competing Marinol oral capsules (5 and 10 mg doses) cause a bolus (i.e., a single administration) spike of THC in the blood, which frequently can produce adverse psychogenic effects.
EPI-004 (Chronic Pain from Cancer)
As with EPI-003, Ethicann believes that using its foundational formulation strategy (or a fine-tuned variant) for EPI-004 to address the market for chronic cancer pain has the potential to be a promising approach, and could open the door to other pain indications.
Post-traumatic stress disorder (PTSD) has become a more widely and commonly diagnosed malady, not only for military service members, but increasingly for firefighters, EMTs and other first responders as well as civilians suffering traumatic injuries (e.g., severe auto accidents). The Company will be clinically exploring the therapeutic utility of EPI-005 in treating these broader patient populations. Ethicann has been encouraged by small studies whereby certain Canadian and U.S. veterans suffering from PTSD have received measurable (1-2 hour) relief by smoking marijuana. A PTSD therapeutic could offer the considerably greater product and safety benefits of a regulated pharmaceutical.
Ethicann has developed an opioid use disorder (OUD) clinical protocol to reduce or prevent opioid addiction in post-surgical patients suffering chronic pain. The protocol combines the use of cannabinoid drugs with medically assisted therapy, which several recent medical papers indicate has been successful in cases in reducing opioid use. An investigational new drug as conceived by Ethicann would use similar formulations as those used in EPI-005; thus, there is the potential that minimal additional product formulation development would be necessary for this product.
Ethicann believes the same clinical protocols and same self-dosing and beneficial effect of the ODT technology as described for EPI-005 can be employed to successfully address this urgent clinical need.
CBD Dose Optimization (for Pipeline Products) and New Indications
Ethicann plans to develop CBD-only Zydis ODT doses, at 15 mg of CBD per dose. First will be to perform dose ranging studies in humans, along with each EPI product (EPI-002 through EPI-006), in order to more rapidly determine the optimum therapeutic dose for each indication, thus facilitating dose optimization.
In parallel, Ethicann intends to develop the CBD-only Zydis tablet for indications where just CBD might be sufficient to show therapeutic effect. This would include juvenile indications, such as epilepsy as well as other non-juvenile indications. The liver removes 30-45% of CBD delivered through the stomach. The approach could be used to lower the amounts of CBD (no liver first pass effect) to achieve a desired therapeutic effect, resulting in lowering liver toxicity associated with CBD.