Artelo Biosciences Announces Publication of New Peer-Reviewed Pre-Clinical Research Demonstrating ART26.12’s Effectiveness in Treating and Preventing Oxaliplatin-Induced Peripheral Neuropathy
Artelo Biosciences, Inc. (ARTL) announced new research published in the peer-reviewed Journal of Pain, highlighting its pre-clinical asset, ART26.12, and its potential ability to treat and prevent Oxaliplatin-Induced Peripheral Neuropathy. The global neuropathic pain market is estimated at $7.6 billion, demonstrating the need for innovative therapy. Artelo has conducted multiple pre-clinical studies in painful neuropathies and anticipates filing the IND for ART26.12 in the first half of 2024.
The announcement of Artelo Biosciences' preclinical research findings regarding ART26.12 presents a significant advancement in the field of neuropathic pain management, particularly for chemotherapy-induced peripheral neuropathy (CIPN). The high incidence of Oxaliplatin-Induced Peripheral Neuropathy (OIPN) among patients and the current lack of FDA-approved treatments for this condition underscore the potential market opportunity for ART26.12. The compound's ability to inhibit Fatty Acid Binding Protein 5 (FABP5) could represent a novel mechanism of action in this therapeutic area. The reported high oral bioavailability and the NOAEL suggest a favorable safety profile at this stage, which is crucial for the progression of ART26.12 into clinical development.
From a medical research perspective, the transition from preclinical studies to an IND filing is a critical juncture. The positive pre-IND meeting with the FDA indicates a constructive dialogue and alignment on the requirements for advancing ART26.12 into human trials. Given the global neuropathic pain market valuation, the successful development of ART26.12 could address a significant unmet medical need, offering a non-opioid alternative that could benefit a wide patient population and potentially capture a notable share of the market.
Artelo Biosciences' progress with ART26.12 is poised to have a material impact on the company's financial prospects. The neuropathic pain market's estimated value of $7.6 billion provides a lucrative target for Artelo's pipeline. The specificity of ART26.12's target, FABP5, aligns with the industry trend towards precision medicine, which could enhance the drug's marketability and pricing power if approved. Moreover, the lack of direct competitors for the treatment of OIPN and paclitaxel-induced neuropathy could allow Artelo to establish a strong market presence.
Investors should note the inherent risks associated with drug development, particularly at the preclinical stage. The transition to clinical trials often comes with increased costs and the success of ART26.12 will be contingent upon favorable clinical outcomes and regulatory approval. However, the positive pre-IND meeting outcomes and the planned IND filing signal a forward momentum that could be a catalyst for investor interest and potential partnerships or funding opportunities.
The therapeutic landscape for neuropathic pain and specifically chemotherapy-induced neuropathies, is characterized by a high unmet need for effective and safe treatments. Artelo Biosciences' ART26.12, if successful, could disrupt this market by providing a non-opioid treatment option. The differentiation of ART26.12 lies in its novel approach to targeting FABP5, which is not currently addressed by other drugs on the market or in clinical development. This uniqueness could facilitate adoption among healthcare providers seeking new options for their patients.
The positive preclinical results and the planned IND filing are likely to attract the attention of stakeholders in the oncology and pain management sectors. Furthermore, the company's strategic focus on non-opioid therapies aligns with the broader industry and regulatory push to reduce opioid dependence. The potential benefits of ART26.12, combined with the vast size of the targeted market, could significantly enhance Artelo Biosciences' positioning within the pharmaceutical industry.
01/23/2024 - 08:30 AM
SOLANA BEACH, Calif., Jan. 23, 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 new research published in the peer-reviewed Journal of Pain . The research article, titled “Discovery and preclinical evaluation of a novel inhibitor of FABP5, ART26.12, effective in Oxaliplatin-induced Peripheral Neuropathy ,” highlights Artelo’s pre-clinical asset, ART26.12, and its potential ability to treat and prevent Oxaliplatin-Induced Peripheral Neuropathy (OIPN) in a series of separate studies.
ART26.12 is a Fatty Acid Binding Protein 5 (FABP5) inhibitor in development for the treatment of chemotherapy-induced peripheral neuropathy (CIPN), a type of neuropathic pain caused by chemotherapy as well as non-chemotherapy cancer treatments such as immunomodulating drugs. Oxaliplatin (OXA) is a commonly used platinum-based antineoplastic agent that causes oxaliplatin-induced peripheral neuropathy (OIPN) in up to 98% of patients treated with OXA, oftentimes resulting in treatment dose reduction, cessation of anti-cancer treatment prematurely, or can result in a painful persistent peripheral neuropathy even after chemotherapy is stopped.
“In pre-clinical safety studies, ART26.12 has shown minimal off target effects, high oral bioavailability, and a NOAEL (no-observed-adverse-effect-level) of 1000 mg/kg/day administration,” commented Andy Yates, PhD, Senior Vice President and Chief Scientific Officer at Artelo. “We are highly encouraged by the four research studies presented in this paper demonstrating ART26.12, our patented and novel treatment approach to inhibiting FABP5, was effective in treating and preventing the painful condition of OIPN.”
According to Coherent Market Insights , the global neuropathic pain market is estimated to be valued at $7.6 billion , demonstrating the need for an innovative therapy that has the potential to provide non-opioid pain relief. Artelo has conducted multiple pre-clinical studies in painful neuropathies, including diabetic neuropathy, paclitaxel-induced peripheral neuropathy, and OIPN, the latter two of which has no FDA-approved treatment. The Company previously reported a positive pre-IND (investigational new drug) meeting with the Food and Drug Administration (FDA) and anticipates filing the IND for ART26.12 in the first half of 2024.
About ART26.12
About Artelo Biosciences www.artelobio.com and Twitter: @ArteloBio .
About CIPN 30% of patients will still have CIPN a year, or more, after finishing chemotherapy.
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: ARTL@crescendo-ir.com
What is the title of the research article published by Artelo Biosciences, Inc.?
The research article is titled 'Discovery and preclinical evaluation of a novel inhibitor of FABP5, ART26.12, effective in Oxaliplatin-induced Peripheral Neuropathy.'
What is the potential of ART26.12 according to the research?
ART26.12 has the potential ability to treat and prevent Oxaliplatin-Induced Peripheral Neuropathy.
What is the estimated value of the global neuropathic pain market?
The global neuropathic pain market is estimated to be valued at $7.6 billion.
What types of neuropathic pain has Artelo conducted pre-clinical studies in?
Artelo has conducted pre-clinical studies in diabetic neuropathy, paclitaxel-induced peripheral neuropathy, and Oxaliplatin-Induced Peripheral Neuropathy.
When does Artelo anticipate filing the IND for ART26.12?
Artelo anticipates filing the IND for ART26.12 in the first half of 2024.
