Artelo Biosciences Announces New Data from an Initial Food Effect Investigation with ART26.12, a Novel Non-Opioid Treatment Candidate for Persistent Pain
Artelo Biosciences (Nasdaq: ARTL) has announced positive results from its preliminary food effect evaluation of ART26.12, their novel non-opioid pain treatment candidate. The assessment was conducted as part of their successful Phase 1 single ascending dose (SAD) clinical trial.
The study demonstrated favorable safety outcomes with no serious adverse events reported. Key findings showed consistent exposure levels under fasted conditions with low inter-subject variability, indicating ART26.12 can be effectively administered with or without food. The drug showed predictable pharmacokinetics and a benign safety profile, crucial characteristics for a chronic pain treatment.
The company is now preparing to advance to a multiple ascending dose (MAD) study, scheduled to begin in Q4 2025, to further evaluate safety, tolerability, and pharmacokinetics with repeated dosing.
Artelo Biosciences (Nasdaq: ARTL) ha comunicato risultati positivi dalla valutazione preliminare dell’effetto del cibo su ART26.12, il loro nuovo candidato terapeutico non oppioide per il dolore. Questa analisi è stata condotta nell’ambito dello studio clinico di Fase 1 a dose singola ascendente (SAD), conclusosi con successo.
Lo studio ha evidenziato esiti di sicurezza favorevoli, senza eventi avversi gravi segnalati. I risultati principali hanno mostrato livelli di esposizione coerenti a digiuno con bassa variabilità tra i soggetti, suggerendo che ART26.12 può essere somministrato efficacemente con o senza cibo. Il farmaco ha mostrato farmacocinetica prevedibile e un profilo di sicurezza benigno, caratteristiche fondamentali per un trattamento del dolore cronico.
L’azienda si sta ora preparando per passare a uno studio a dosi ascendenti multiple (MAD), previsto per iniziare nel quarto trimestre del 2025, per valutare ulteriormente sicurezza, tollerabilità e farmacocinetica con somministrazioni ripetute.
Artelo Biosciences (Nasdaq: ARTL) ha anunciado resultados positivos de su evaluación preliminar del efecto de los alimentos sobre ART26.12, su nuevo candidato no opioide para el tratamiento del dolor. La evaluación se realizó como parte del ensayo clínico de Fase 1 de dosis única ascendente (SAD), que se completó con éxito.
El estudio mostró resultados de seguridad favorables, sin eventos adversos graves reportados. Los hallazgos clave indicaron niveles de exposición consistentes en ayunas con baja variabilidad entre sujetos, lo que sugiere que ART26.12 puede administrarse de forma efectiva con o sin alimentos. El fármaco presentó farmacocinética predecible y un perfil de seguridad benigno, características esenciales para un tratamiento del dolor crónico.
La compañía se está preparando ahora para avanzar a un estudio de dosis ascendentes múltiples (MAD), programado para comenzar en el cuarto trimestre de 2025, con el fin de evaluar más a fondo la seguridad, la tolerabilidad y la farmacocinética con dosificaciones repetidas.
Artelo Biosciences (Nasdaq: ARTL)는 자사의 새로운 비오피오이드 진통 후보물질 ART26.12에 대한 예비 식이(음식) 영향 평가에서 긍정적 결과를 발표했습니다. 이 평가는 성공적으로 완료된 1상 단회 용량 상승(SAD) 임상시험의 일환으로 수행되었습니다.
연구는 우호적인 안전성 결과를 보였으며, 중대한 이상반응은 보고되지 않았습니다. 주요 결과는 공복 상태에서 일관된 약물 노출과 낮은 피험자 간 변동성을 나타내 ART26.12가 음식 유무와 관계없이 효과적으로 투여될 수 있음을 시사합니다. 해당 약물은 예측 가능한 약동학과 양호한 안전성 프로파일을 보였으며, 이는 만성 통증 치료제에 중요한 특성입니다.
회사는 현재 반복 투여 시 안전성, 내약성 및 약동학을 추가 평가하기 위해 2025년 4분기에 시작될 예정인 다회 투여 용량 상승(MAD) 연구로의 진행을 준비하고 있습니다.
Artelo Biosciences (Nasdaq: ARTL) a annoncé des résultats positifs de son évaluation préliminaire de l’effet des aliments sur ART26.12, son nouveau candidat thérapeutique non opioïde pour la douleur. L’évaluation a été réalisée dans le cadre de l’essai clinique de phase 1 en dose unique ascendante (SAD), mené avec succès.
L’étude a montré des résultats de sécurité favorables, sans événements indésirables graves signalés. Les résultats clés ont révélé des niveaux d’exposition cohérents à jeun avec une faible variabilité inter-sujets, indiquant qu’ART26.12 peut être administré efficacement avec ou sans nourriture. Le médicament a présenté une pharmacocinétique prévisible et un profil de sécurité bénin, des caractéristiques cruciales pour un traitement de la douleur chronique.
L’entreprise se prépare désormais à passer à une étude en doses ascendantes multiples (MAD), prévue pour commencer au 4e trimestre 2025, afin d’évaluer plus avant la sécurité, la tolérance et la pharmacocinétique lors d’administrations répétées.
Artelo Biosciences (Nasdaq: ARTL) hat positive Ergebnisse aus der vorläufigen Untersuchung des Nahrungsmittel-Effekts für ART26.12, ihren neuen nicht-opioiden Schmerzwirkstoffkandidaten, bekannt gegeben. Die Bewertung erfolgte im Rahmen der erfolgreich abgeschlossenen Phase‑1-Studie mit einmaliger, aufsteigender Dosierung (SAD).
Die Studie zeigte günstige Sicherheitsbefunde, es wurden keine schwerwiegenden unerwünschten Ereignisse berichtet. Wesentliche Erkenntnisse waren konsistente Expositionswerte im nüchternen Zustand bei geringer interindividueller Variabilität, was darauf hinweist, dass ART26.12 wirksam mit oder ohne Nahrungsaufnahme verabreicht werden kann. Das Medikament zeigte vorhersehbare Pharmakokinetik und ein benignes Sicherheitsprofil — wichtige Eigenschaften für eine Therapie bei chronischen Schmerzen.
Das Unternehmen bereitet nun den Übergang zu einer Studie mit mehrfach ansteigenden Dosen (MAD) vor, die im 4. Quartal 2025 beginnen soll, um Sicherheit, Verträglichkeit und Pharmakokinetik bei wiederholter Gabe weiter zu untersuchen.
- Favorable safety profile with no serious adverse events reported in clinical trials
- Demonstrated consistent drug exposure levels with low inter-subject variability
- Flexibility in administration - can be taken with or without food
- Successfully completed SAD study and advancing to MAD study in Q4 2025
- None.
Insights
Artelo's ART26.12 shows favorable safety profile and flexible dosing potential, advancing to next clinical phase for novel pain treatment.
Artelo's preliminary food effect study results for ART26.12 represent an important early clinical milestone for this first-in-class FABP5 inhibitor. The data demonstrates two key pharmaceutical development advantages: a clean safety profile with only mild, self-limiting adverse events, and dosing flexibility that doesn't require food restrictions. This pharmacokinetic predictability with low inter-subject variability is particularly valuable for chronic pain medications where consistent drug exposure is critical for efficacy.
The ability to dose with or without food removes a significant potential barrier to patient compliance and clinical utility. For pain management therapies intended for long-term use, such flexibility provides meaningful advantages over compounds with strict dietary requirements.
This study builds momentum toward the upcoming multiple ascending dose (MAD) trial scheduled for Q4, which will assess repeated dosing effects - a crucial step before potential efficacy studies. The non-opioid mechanism represents a significant potential advantage in the pain market, where alternative mechanisms are desperately needed amid the ongoing opioid crisis.
While these are early-stage results, the compound's dual attributes of clean safety data and convenient dosing establish a solid foundation for continued development in the challenging pain therapeutic area, where many candidates fail due to tolerability issues or complicated administration requirements.
Safety and Pharmacokinetic Data Support Dosing of
ART26.12 in Fed or Fasted Conditions
Completion of Positive Single Ascending Dose Study with a Preliminary Food Effect Assessment
Advances ART26.12 Toward Multiple Ascending Dose Trial
SOLANA BEACH, Calif., Aug. 25, 2025 (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, dermatological or neurological conditions, today announced encouraging results from its preliminary food effect evaluation with ART26.12. This assessment was conducted as a part of the successful single ascending dose (SAD) Phase 1 clinical trial evaluating ART26.12, the first selective oral small molecule fatty acid binding protein 5 (FABP5) inhibitor dosed in the clinic.
The food effect interrogation was designed to assess the pharmacokinetics and safety profile ART26.12 in healthy volunteers under both fed and fasted conditions. The selected dose was based on previously established safety and pharmacokinetic data from the SAD study, where there were no drug-related adverse events reported.
Key findings include:
- Favorable Safety Profile: Participants received three single doses of ART26.12 separated by 7-day intervals. No serious adverse events, safety concerns, or tolerability issues were identified. All reported adverse events were mild, self-limiting, and consistent with those observed in the SAD study.
- Predictable Pharmacokinetics: Data showed consistent exposure levels under fasted conditions across the both the food effect evaluation and SAD study, indicating low inter-subject variability. Plasma pharmacokinetics further suggest ART26.12 can be effectively administered with or without food.
- Clinical Development Momentum: The profile observed from the SAD and Food Effect study provides a strong foundation for advancing to the upcoming multiple ascending dose (MAD) study.
“We are delighted to have successfully concluded our initial step in the human investigation of ART26.12. The SAD and Food Effect study provides us with the knowledge that we can choose to dose in both the fed or fasted state in future trials,” said Andrew Yates, Ph.D., Senior Vice President and Chief Scientific Officer at Artelo. “The results generated to date provide our first indication of predictable pharmacokinetic behavior and a benign safety profile—both of which are highly desirable in a pain drug intended for chronic use,” continued Dr. Yates.
Preparations are underway to initiate a MAD study to further evaluate the safety, tolerability, and pharmacokinetics of ART26.12 with repeated dosing over time. The MAD study is planned to commence dosing subjects in the fourth quarter this year.
About ART26.12
ART26.12 is a selective, orally administered, and peripherally acting FABP5 inhibitor. ART26.12 represents a new therapeutic class with a non-opioid, non-steroidal analgesic approach designed to target a novel mechanism in pain modulation by altering endogenous lipid species in pain-relevant tissues. These lipid messengers influence multiple known pain pathways, including transient receptor potential vanilloid 1 (TRPV1), peroxisome proliferator-activated receptor alpha (PPAR-α), and cannabinoid receptors, with emerging evidence of modulation of additional targets such as Nav1.8. The initial clinical development planned is for chemotherapy-induced peripheral neuropathy (CIPN). FABPs are a family of intracellular proteins that chaperone lipids important to normal cellular function. FABP is overexpressed and associated with abnormal lipid signaling in several pathologies. In addition to ART26.12 in CIPN, Artelo’s extensive and proprietary library of small molecule inhibitors of FABPs has shown therapeutic promise for the treatment of certain cancers, neuropathic and nociceptive pain, psoriasis, and anxiety disorders. The U.S. National Institutes of Health (NIH) has included ART26.12 in its Helping to End Addiction Long-term® (HEAL) initiative’s Preclinical Screening Platform for Pain (PSPP) program. Through the HEAL PSPP, the NIH is dedicated to advancing non-opioid solutions to pain and curbing opioid use disorder.
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, with a diversified pipeline addressing significant unmet needs in anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Complementing its scientific innovation, Artelo adopted a forward-looking corporate finance initiative whereby it is deploying a portion of its excess capital into Solana under a digital asset treasury strategy. Artelo intends to leverage Solana to diversify its balance sheet, enhance liquidity management, and position the Company for long-term value creation to support its therapeutic programs. Led by an experienced executive team collaborating with world-class researchers and digital-asset technology partners, Artelo applies rigorous scientific, regulatory, commercial, and treasury management practices to maximize stakeholder value. More information is available at www.artelobio.com and X: @ArteloBio.
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, timing of the Company’s planned clinical trials and related data readouts, efficacy of the Company’s product candidates, results and conclusions from preclinical studies and clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements 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:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: ARTL@crescendo-ir.com
FAQ
What are the key findings from Artelo Biosciences' (ARTL) ART26.12 food effect study?
When will Artelo Biosciences begin the Multiple Ascending Dose (MAD) study for ART26.12?
What makes ART26.12 unique as a pain treatment candidate?
What were the safety results from Artelo's ART26.12 clinical trials?
How does the pharmacokinetic profile of ARTL's ART26.12 benefit patients?
