NanaBis - Drug Programme

Dr Sean Hall

The PAIN epidemic is real. We need to think differently. We need to innovate. We need to provide effective solutions.

For 65 million US adults, chronic pain is an issue requiring medical attention.

Medlab is advancing the development of NanaBis™, a multi-jurisdictional, patent-protected, non-opioid analgesic drug candidate that treats cancer and non-cancer pain designed to compete directly against the US$42 billion global opioid market. NanaBis™ is , initially designated for the treatment cancer bone pain but is expected to have broader applications across oncology and non-cancer pain indications.

NanaBis™ consists of a synthetic mixture of CBD and delta-9-THC in a 1:1 ratio of 9.62 mg/mL CBD to 9.62 mg/mL THC. The formulation is a synthetic, standardized 1:1 blend of CBD and dronabinol, the delta 9 isomer of THC, in a patented submicron particle delivery platform (NanoCelle) optimized for buccal delivery.

Unlike opioids, NanaBis™ is a NanoCelle-delivered, synthetic, equimolar formulation comprising CBD and THC (Dronabinol), with its origins from standardized phyto-material, specifically targeting pain. Historically, NanaBis™ has undergone extensive clinical work, resulting in multiple publications, including published pharmacokinetic comparisons to Nabiximols at equivalent doses.

Comparison table showing pharmacokinetics of NanaBis™ at 2.5 mg THC and 2.5 mg CBD.

Published work shows NanaBis used in patients with advanced cancer and intractable pain, provided superior pain relief ~40% reduction (p<0.01) in patients with bone metastases, improvements in quality of life (QoL) and significant reductions in morphine milli equivalent.

Its opioid-sparing capability is designed to provide clinicians with an alternative approach to managing severe pain without well-documented risks of traditional opioids. In addition, its safety profile, particularly the absence of CARPA (a concern with some nanoparticle systems), may support potential long-term use. Based on these attributes, we believe NanaBis™ may represent a viable candidate for regulatory approval and, if approved, may have applicability in broader pain management settings. We believe these factors could make NanaBis™ an attractive therapeutic option for physicians and patients subject to the outcome of ongoing and future clinical studies and regulatory processes. If ultimately approved, NanaBis™ could compete in the multi-billion dollar global pain management market.

Slide presentation titled "NanaBis™ - Robust Clinical Experience" showing study results with bullet points on cancer pain patients, bone metastasis, quality of life, and MM EQ reduction, along with a bar graph depicting changes in MM EQ over time for different patient groups.

Ethics approved, first in man, Phase 1/2 outcomes were impressive amnd subsequently published:

With extended PK modelling by the University of South Australia, published:

Overview of Phase II clinical trial results showing efficacy and safety of NanoCelle treatment for advanced cancer pain. Patients on NanoBis used 6.4 mg daily of THC and CBD, less than half the dose of THC and CBD used in patients on Nabiximols spray, with improvements in pain, quality of life, and safety. Graphs highlight a 40% reduction in pain severity, with no major adverse events.

Ethics approved, RWE data across ~1200 subjects shows alignment to Phase 1/2 findings.

Patient case report for a 35-year-old female with epithelioid sarcoma, showing medication details, treatment progress, and patient quotes, with a human body illustration highlighting pain areas.
Patient case report for NanaBis showing detailed medical history, medication dosages, symptoms before treatment, and outcomes such as reduced migraines and improved sleep, with a diagram of human body highlighting pain areas.

PROGRESSION STATUS

Principle Agency: FDA

Proposed Pathway: 505(b)(2)

Initial Indication: Cancer Induced Bone Pain

Claim Expansion: Nociplastic Pain

Next: awaiting guidance from FDA

Next Trial: n/a

EA-IND : Applications closed at this time

Physician Led IND: Applications closed at this time