London Research & Pharmaceuticals presents the advancement of LRP-661, their oral cannabidiol sulphate drug candidate at the prestigious Epilepsy Therapies & Diagnostics Development (ETDD) XVII conference in Miami

When compared against the currently available oral solution of cannabidiol in a sesame oil suspension, CBDS shows no effect on gastrointestinal tolerability (no diarrhea) and no weight loss in animals, as well as no liver or renal toxicity and low affinity for many CYP-450 isozymes (such as 1A2, 3A4, 2B6) or P-glycoprotein (P-GP), which are responsible for many adverse drug-drug interactions.

CBDS demonstrates high activity in several preclinical epilepsy models in which seizures are induced in animals through either the administration of an electrical shock (such as Maximal Electroshock Seizure [MES] and MES Threshold models) or the administration of a seizure-inducing compound, such as pentylenetetrazol (PTZ) in the PTZ-induced seizure mice model.

This data was presented at the prestigious ETDD XVII conference in Miami on June 2^nd, 2023, and was well received by the expert audience. It remains widely acknowledged that the clinical utility of cannabidiol is severely limited by the safety, tolerability, and bioavailability of the current sesame oil-based formulation.

Henrik Klitgaard, Ph.D., a widely respected epilepsy industry expert and former Head of Epilepsy Research at UCB from 1994 to 2019, led the early development of several very successful antiseizure medications such as levetiracetam and brivaracetam. Following the ETDD XVII conference, Dr. Klitgaard was quoted as saying, "CBD sulphate is a very clever new formulation of cannabidiol, which has the potential to overcome many of the drawbacks of the currently marketed product. This should substantially improve tolerability and compliance among patients, particularly in a pediatric population, and in turn allow clinicians to administer higher daily doses without fear of organ toxicity including liver, allowing for less rigorous follow-up and potentially improving clinical efficacy. This new drug also presents the opportunity to pursue a broad epilepsy indication, starting with an add-on in drug-resistant partial seizures but ultimately it could be widely used as monotherapy in partial or generalized seizures if it demonstrates its utility in future clinical trials."

Dr. Moustafa, Ph.D., and R&D Lead at London Research & Pharmaceuticals remarked, "By developing an orally available formulation of cannabidiol, we demonstrate the expertise of London Research in medicinal chemistry and drug formulation and offer a novel compound with clear pharmacological and clinical differentiation, while considering the regulatory path. We are very excited by the clinical and commercial potential of CBDS and look forward to advancing it rapidly to a clinical program while maintaining our ability to progress multiple other compounds in our pipeline. We anticipate approaching the FDA in the 2nd quarter of 2024 for a pre-IND meeting to assess the adequacy of our pre-clinical data and agree on a regulatory and clinical development process to bring LRP-661 (CBDS) to market as efficiently as possible."

Following their presentation at ETDD XVII, London Research & Pharmaceuticals accepted a podium presentation invitation from Dr. Meir Bialer at the EILAT XVII held in Madrid, May 2024.

About LRP-661 (CBD sulphate): LRP-661 or CBD sulphate (CBDS) is the lead compound in London Research & Pharmaceuticals's portfolio. It is an orally available and improved formulation of cannabidiol (CBD). The only prescription formulation of cannabidiol marketed currently is Epidiolex^® (a registered trademark of Jazz Pharma), which is indicated in the US and Europe for the treatment of seizures associated with severe childhood epilepsy syndromes (such as Lennox-Gastaut syndrome, or LGS, Dravet syndrome, or DS, as well as tuberous sclerosis complex, or TSC) and achieved sales of $736 million in 2022 (source: Jazz Pharma Annual Report). Epidiolex^® is an oral solution containing cannabidiol at a concentration of 100 mg/mL, as well as inactive ingredients including sesame seed oil (736 mg per ml of oral solution), anhydrous ethanol, or dehydrated alcohol (79 mg per ml), strawberry flavor including benzyl alcohol, and sucralose (sources: US Package Insert and EU Summary of Product Characteristics).

We anticipate CBD sulphate accessing the market rapidly through a 505(b)(2) New Drug Application (NDA) filing pathway. However, we continue to prepare a 505(b)(1) preclinical data package until an official FDA ruling is completed. The 505(b)(2) NDA is a streamlined NDA process in which the applicant relies upon previous data conducted by someone other than the applicant and for which the applicant has not obtained a right of reference. In contrast, a 505(b)(1) requires the drug sponsor to conduct all necessary studies to demonstrate the safety and efficacy of the drug, implying substantially longer and costlier drug development. London Research & Pharmaceuticals is planning to run a clinical program to enable clinical differentiation between LRP-661 (CBDS) and Epidiolex^®.

About London Research & Pharmaceuticals: The company is focused on synthesizing highly druggable formulations of existing compounds. Beyond LRP-661 (CBDS), London Research & Pharmaceuticals has generated preclinical data on the following compounds:

• LRP-666, a delta-9-tetrahydrocannabinol or THC sulphate (THCS) in early-mid stage preclinical development for inflammation and neuropathic pain. THCS is part of the same LRP sulphate platform as CBDS.
• ID-001, a small molecule in late-stage preclinical development for infectious diseases.
• ON-001, a small molecule in early-stage preclinical development for oncology indications.
• IB-001, a small molecule in early-stage preclinical development for inflammatory bowel syndrome.
• MH-001, a small molecule in early-stage preclinical development for a range of psychiatric disorders (MDD, addiction, anxiety, PTSD) and palliative care.
  

London Research & Pharmaceuticals is privately held and open to partnering discussions for its proprietary compounds.

Contact:
Dr. Mark Innamorato
Chief Strategy Officer
Email: [email protected]
Website: www.londonresearch.ca