Artelo Biosciences Announces Selection of Worldwide Clinical Trials as Clinical Research Organization to Support First-in-Human Study of ART26.12
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Insights
The selection of Worldwide Clinical Trials by Artelo Biosciences to support their Phase 1 trial for ART26.12, a Fatty Acid Binding Protein 5 (FABP5) inhibitor, is a strategic move within the biopharmaceutical industry. The focus on chemotherapy-induced peripheral neuropathy (CIPN) targets a significant unmet medical need, as CIPN currently lacks FDA-approved treatments. This is noteworthy considering the global neuropathic pain market's valuation at approximately $7.6 billion, indicating a substantial market opportunity for Artelo if ART26.12 proves to be effective and safe in human trials.
From a research perspective, the positive outcomes observed in multiple animal models for ART26.12 suggest a promising therapeutic profile. However, it's critical to approach these results with cautious optimism, as efficacy in animal models does not always translate to human patients. The pre-IND meeting outcomes and the anticipated IND filing set a positive regulatory trajectory, but the true test will come with the commencement of Phase 1 trials and subsequent data on safety and efficacy in humans.
Artelo's partnership with Worldwide Clinical Trials could potentially expedite the development process of ART26.12 due to the CRO's expertise in neurology and track record in clinical trials. Investors should note the strategic alignment with a CRO that has a focused therapeutic area expertise, which may reduce development risks and improve trial efficiency. The decision to target CIPN, a condition with no current FDA-approved treatments, aligns with an industry trend of seeking niche markets with high unmet needs, which can lead to expedited regulatory pathways and potentially higher pricing power upon successful product launch.
It is also important to consider the competitive landscape of the neuropathic pain market and Artelo's positioning within it. The non-opioid pain management space is highly attractive due to the ongoing opioid crisis and a new, effective treatment could disrupt the market. However, the development stage of ART26.12 means it will be several years before it could reach the market and investors should weigh the risks associated with clinical development against the long-term potential returns.
The pharmaceutical industry has seen a surge in the development of treatments modulating lipid-signaling pathways and Artelo's FABP5 inhibitor, ART26.12, is a testament to this growing field. Lipid signaling has broad potential in therapeutics and a successful FABP5 inhibitor could pave the way for a new class of treatments. The partnership with Worldwide Clinical Trials could also be indicative of Artelo's commitment to advancing its pipeline efficiently and may reflect positively on the company's operational capabilities.
However, the path from Phase 1 trials to market approval is fraught with high attrition rates and the financial implications for Artelo will be significant. The costs associated with clinical trials are substantial and the company will likely require additional funding, partnership, or licensing deals to continue the development of ART26.12. The progress of the drug candidate should be monitored closely, as each phase of clinical trials will be critical in determining the future financial health and stock performance of Artelo Biosciences.
SOLANA BEACH, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced that it has selected Worldwide Clinical Trials (“Worldwide”), a global award-winning contract research organization (CRO) therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease, to support the Company’s planned Phase 1 trial with ART26.12, its Fatty Acid Binding Protein 5 (FABP5) inhibitor in development for the treatment of chemotherapy-induced peripheral neuropathy (CIPN).
“We look forward to working with Worldwide once we obtain approval from the FDA to advance ART16.12 into Phase 1 clinical development,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. “With Worldwide’s extensive experience in the neurology space and successful track record of assisting companies progress through trials, we believe we are well positioned to leverage ART26.12’s positive profile observed in multiple animal models of painful neuropathies to progress to human studies.”
“We are excited to partner with the Artelo Biosciences team on their important advancement with ART26.12,” stated Peter Benton, President and Chief Executive Officer of Worldwide Clinical Trials. “Given the broad potential of lipid-signaling in therapeutics development and more specifically the prospects for ART26.12 as a non-opioid pain drug, we look forward to supporting Artelo in the evaluation of safety with their promising FABP5 inhibitor.”
According to Coherent Market Insights, the global neuropathic pain market is estimated to be valued at
About ART26.12
Fatty Acid Binding Proteins (FABPs) are a family of intracellular proteins that chaperone lipids including endocannabinoids and fatty acids. FABP is overexpressed and associated with abnormal lipid signaling in a number of pathologies. ART26.12, Artelo’s lead FABP inhibitor, is a potent and selective inhibitor of FABP5 being developed as a novel, peripherally acting, non-opioid, non-steroidal analgesic, with an initial clinical study planned for chemotherapy-induced peripheral neuropathy (CIPN). Beyond ART26.12, Artelo’s extensive library of small molecule inhibitors of FABPs have shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, and anxiety disorders.
About Worldwide Clinical Trials
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com.
About Artelo Biosciences
Artelo Biosciences, Inc. is a clinical stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways including the endocannabinoid system. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at www.artelobio.com and Twitter: @ArteloBio.
About CIPN
Chemotherapy induced peripheral neuropathy (CIPN) is a type of neuropathic pain caused by chemotherapy as well as non-chemotherapy cancer treatments such as immunomodulating drugs. CIPN is a major challenge with many oncological treatments, sometimes resulting in dose reduction or cessation of the cancer treatment, negatively impacting efficacy and survival. Acute CIPN occurs during chemotherapy and chronic CIPN can last months to years. Around
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission, including our ability to raise additional capital in the future. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable securities laws.
Investor Relations Contact:
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Tel: 212-671-1020
Email: ARTL@crescendo-ir.com
FAQ
What is the name of the clinical-stage pharmaceutical company mentioned in the press release and its ticker symbol?
What is ART26.12 and what is it being developed for?
What is the estimated value of the global neuropathic pain market?
When does Artelo anticipate filing the IND for ART26.12?
