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Zelira Therapeutics Aims to Disrupt the Global Medical Cannabis Market

04 Mar Zelira Therapeutics Aims to Disrupt the Global Medical Cannabis Market

Zelira Therapeutics (OTCQB: ZLDAF), a biopharmaceutical Company developing cannabinoid-based formulations for the treatment of a wide range of medical conditions, announced full enrollment in its Phase 1 Dose Escalation Trial in patients on long-term opioid treatment for non-cancer pain. The study intends to evaluate the safety, efficacy and tolerability of its unique formulation of whole plant extracts following single and repeated doses with escalation, along with secondary outcomes such as its effect on pain, mood, sleep and usage during the course of the trial.

The Company intends to complete dosing by April 2020, with results from the study expected to be announced by mid-2020. No serious adverse events have been reported till date. The trial is being held at the St Vincent’s Hospital in Melbourne, in collaboration with Emerald Clinics Ltd (ASX: EMD), who will act as the second site in Perth.

Dr Richard Hopkins, Managing Director of Zelira, Commented,

“We are delighted to have achieved full enrolment, which represents a major milestone for the trial. We’re also pleased for the opportunity to expand our partnership with Emerald Clinics by bringing them on as a second site. We have been impressed by their ability to complement the efforts of the St Vincent team by rapidly screening and enrolling eligible patients into trial”.

 In addition to Chronic Pain, the company is also studying the possibility of using cannabinoid-based medications for the treatment of Insomnia, Autism, Pancreatic Cancer, Breast Cancer, Brain Cancer and Diabetes related cognitive decline.

Zelira Therapeutics (OTCQB: ZLDAF)

Market Cap: $23.85M; Current Share Price: 0.039 USDChart
Data by YCharts

Chronic Pain is the leading cause for seeking medical aid in the U.S. A study undertaken by the Centres for disease control and prevention (CDC) in conjunction with NIH and other entities titled “Morbidity and Mortality Weekly Report (MMWR)”in the year 2016, estimates that 20.4% percent of the adults population in the U.S suffered from chronic pain, while 8 percent had high-impact chronic pain limiting at least one important activity in their daily life. Untreated or undertreated chronic pain contributes to$560 billion each year in direct medical costs, lost productivity, and disability programs in the U.S alone.

The global analgesic market is poised to amass $ 26.4 billion by 2022, growing at a CAGR of 7.1% during 2015 – 2022, according to a report titled “Analgesics Market by Type (Non-opioids, Opioids) and Route of Administration (Oral, Intravenous, Rectal, Transdermal, Topical) – Global Opportunity Analysis and Industry Forecast, 2015 – 2022” published by alliedmarketresearch.

The Analgesic market is broadly divided into Opioid and Non-Opioid therapeutics. Opioid based medicine has given rise to an addiction endemic with prescription drug overdose becoming one of the leading causes of preventable deaths in the U.S in turn prompting the government to declare a public health emergency in 2017.

This has resulted in growth in the non-opioid based drugs segment, with increasing emphasis being laid on research and development in finding non-opioid alternatives to managing chronic pain. According to a study published by BBC research named “Non-opioid Pain Treatment: Global Markets to 2022” the global market for non-opioid pain treatment which was $ 9.9 billion in 2017, is estimated to grow at a CAGR of 18% and reach $ 22.6 billion by 2022.

The largest product category under non-opioid pain treatment is that of Medical cannabis constituting 73% of the market, followed by Menthol – Containing treatments accounting for 9% of market share. Omega-3 fatty acid based treatments constitute 9% of the market share, followed by Botulinum toxins based drugs that contribute 5% and Capsaicin derived treatment make up 3% of the market share.

An increase in the geriatric population along with a rise in life-style related ailments and chronic diseases will drive the growth in the non-opioid market, along with a favourable government and regulatory environment, increased spending on research and development and fast track approvals for breakthroughs.

Zelira therapeutics, formed through the merger of Zelda Therapeutics and Ilera Therapeutics, is developing a pipeline of candidates aimed at disrupting the medical cannabis-based pharmaceutical market. The merger not only created synergies and enhanced shareholder value, but also led to the formation of a medical cannabis company with access to the fastest growing cannabis markets worldwide. The acquisition also helped Zelira to expand its operations to international markets, leveraging Ilera’s HOPE brand. The Company also intends to create a range of cosmetic products, through a dermatology subsidiary for the retail markets.

Image Source: Company

The Company is developing a portfolio of robust clinical candidates that are likely to reach the market from 2020 onwards, besides it already existing proprietary revenue generating products. In December 2019, Zelira expanded the distribution of HOPE, a proprietary formulation of medicinal cannabis intended for the treatment of patients with Autism Spectrum Disorder.

Image Source: Company

The licensing agreement, commercial terms of which remain confidential, will generate immediate revenue in the form of an up-front fee and ongoing royalties. Zelira has also entered into a partnership with Ethicann for developing CAN-001, for the treatment of chemotherapy-induced nausea and vomiting (CINV) in cancer patients.

Risk Assessment

  • Zelira has built strategic partnerships with world-renowned organizations such as Complutense University in Madrid, Spain; Curtin University in Perth, Western Australia; the Telethon Kids Institute; the University of Western Australia, in Perth; St. Vincent’s Hospital in Melbourne, Australia; and the Children’s Hospital of Philadelphia (CHOP) in the United States, which help the Company explore possible areas of application of its proprietary formulation through human clinical trials and preclinical research.
  • The merger with Illera resulted in the Company gaining long-term supply and distribution relationships in Europe with HAPA Pharm BV, giving it access to EU-GMP grade manufacturing capabilities and its German distribution network. In the U.S the Company has tied-up with TerrAscend/Ilera Healthcare and Advanced Biomedics LLC resulting in access to resources that offer scalability along with top-quality produce.
  • The Company is making inroads into markets with huge potential and those that offer excellent opportunities for growth and expansion such as U.S, Australia and Europe. The Company is aiming to launch multiple products globally in 2020 in order to gain a stronghold in the global cannabis market.
  • Zelira is adopting a multipronged approach to growth and expansion, with plans to launch a dermatology subsidiary under the guidance of Karyn Grossman, a world-renowned dermatologist. In addition, the Company is also aiming to develop an oral mucosal formulation in partnership with SUDA.
  • The Company is helmed by an experienced management team that has extensive experience in areas such as capital markets, pharmaceuticals, branding, licensing and clinical trials.
  • Zelira intends to use a highly differentiated commercialization strategy with focus on adding value through clinical validation, creation of proprietary formulations and building a robust intellectual property rights portfolio. This will be followed up by targeting multistate operators for licensing deals including licensing for products, Intellectual property, technical and clinical dossiers.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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