Cannabidiol/Dronabinol

Single Ascending and Multiple Ascending Dose Trial Demonstrated AJA001 to be Safe and Well-tolerated, with Formulation Optimized for ASD Presentation at the 63rd Annual Meeting of the American College of Neuropsychopharmacology LITTLETON, Colo., Dec. 12, 2024 /PRNewswire/ -- DeFloria, a joint venture between Ajna BioSciences and Charlotte's Web (TSX: CWEB, OTCQX: CWBHF), reported positive results from a Phase 1 single ascending and multiple ascending dose trial of AJA001 in development for the treatment of symptoms of autism spectrum disorder (ASD) in a poster presentation at the 63rd Annual Meeting of the American College of Neuropsychopharmacology in Phoenix, Arizona. AJA001 is an orally delivered, multi-cannabinoid botanical drug product (BDP) designed to provide a broad therapeutic effect. In a poster entitled, "A Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJA001, a Full-Spectrum Hemp-Derived Botanical Drug for Autism Spectrum Disorder, " Marcel O. Bonn-Miller, Ph.D., Chief Scientific Officer at Charlotte's Web and Board Member at DeFloria, presented the results from the recently completed Phase 1 randomized, double-blind, placebo-controlled trial that evaluated the tolerability and pharmacokinetic (PK) / pharmacodynamic (PD) profile of several dose levels of AJA001 in 70 healthy volunteers ranging from 19 to 55 years. Results demonstrated that AJA001 was well-tolerated at doses up to 680 mg per day administered as a single dose and up to 660 mg per day administered twice a day. In both the single and multiple ascending dose portions of the trial, AJA001 displayed dose-proportional PK for CBD and THC that matched or exceeded the plasma concentrations of the comparable cannabinoid therapeutics dronabinol, nabiximols, and Epidiolex®. PK data following multiple dose administration of AJA001 showed minimal accumulation of CBD or THC after 7 days. AJA001's PD effects were shown to be dose-dependent and correlated with peak plasma concentrations of THC and its active metabolite 11-OH-THC after administration of single doses. An analysis of participant responses on the Drug Effects Questionnaire (DEQ) demonstrated that the magnitude and time course of AJA001's subjective drug effects were moderate and transient in nature. The safety, PK, and PD findings support doses from 100 mg to 660 mg of AJA001 per day for Phase 2 trials in children, adolescents, and adults with ASD. This is equivalent to an upper limit of 395 mg CBD and 15 mg THC per day. The most common treatment emergent adverse events in the AJA001 treated groups were somnolence, anxiety, dizziness, and headache. One serious adverse event was reported by a participant receiving 906.4 mg of AJA001 who reported anxiety that resolved by the next day with no sequalae. A copy of the poster is available on the DeFloria website at . "We are extremely encouraged by these results from our Phase 1 single and multiple ascending dose trial, which demonstrate that AJA001 is well-tolerated across a range of doses and provides a favorable pharmacokinetic profile for both cannabidiol and tetrahydrocannabinol," said Dr. Bonn-Miller. "Importantly, the results from this trial inform the doses to be evaluated in upcoming Phase 2 clinical trials of AJA001 in children, adolescents, and adults with ASD." "We are excited to present this important data and look forward to initiating two Phase 2 trials of AJA001 in ASD in the second quarter of 2025," said Jared Stanley, CEO of DeFloria. "Despite its prevalence, ASD remains a difficult condition to treat. Moreover, currently available treatments for ASD are not well tolerated, making patient compliance a challenge. DeFloria is committed to supporting the ASD community and developing AJA001 to treat the behavioral symptoms associated with ASD with a drug product that is designed to provide broad therapeutic efficacy." About ASD Approximately 1 in 36 children may have ASD (Maenner et al 2023). ASD is characterized by core deficits in (1) social communication, (2) impaired reciprocal social interactions, and (3) restricted, repetitive and stereotyped patterns of behaviors or interests. Irritability, impulsivity, and "temper tantrums" are common symptoms and contribute to high caregiver burden (Lecavalier et al 2006). About AJA-001 AJA001 Oral Solution is a botanical drug product (BDP) containing full spectrum hemp extract (FSHE) botanical drug substance (BDS) derived from Cannabis sativa L proprietary CW1AS1 hemp cultivar. The primary cannabinoid is cannabidiol (CBD). As an innovative multi-cannabinoid formulation, it may provide broad therapeutic efficacy. Its full-spectrum composition has potential therapeutic applications across various medical conditions due to its varied mechanisms of action. About DeFloria DeFloria LLC, a collaboration between Charlotte's Web, Inc., AJNA BioSciences PBC, and British American Tobacco PLC (BAT), is on a mission to address crucial healthcare needs through groundbreaking innovations from multi-compound drugs originating in nature. With a combined century of experience in regulatory, research, and quality-controlled standardized manufacturing, DeFloria's ambitious endeavor aims to secure FDA approval for a novel cutting-edge botanical drug developed from Charlotte's Web proprietary hemp genetics that targets a neurological condition identified by the DeFloria leadership and research teams. Cautionary Note of Forward-Looking Statement This news release contains "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of DeFloria, LLC to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained in this news release. Examples of such statements and uncertainties include statements with respect to future dose trial results, therapeutic efficacy, or approvals of AJA001 Oral Solution. Risks, uncertainties and other factors involved with forward-looking statements could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking statements, including negative outcomes in future dose trials, therapeutic efficacy, or delays in approvals of AJA001 Oral Solution. In respect of the forward-looking statements, DeFloria, LLC has provided such statements in reliance on certain assumptions that it believes are reasonable at this time. Although DeFloria, LLC and its collaborators and partners believe that the assumptions and factors used in preparing the forward-looking statements in this news release are reasonable, undue reliance should not be placed on such information or statements and no assurance can be given that such events will occur in the disclosed time frames or at all. Should one or more of the foregoing risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although DeFloria, LLC has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The forward-looking statements included in this news release are made as of the date of this news release and DeFloria, LLCs does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities laws. Investor/Media Contact Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected] References: Maenner MJ, Warren Z, Williams AR, et al. Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years — Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020. MMWR Surveill Summ 2023;72(No. SS-2):1–14. Lecavalier L, Leone S, Wiltz J. The impact of behaviour problems on caregiver stress in young people with autism spectrum disorders. J Intellect Disabil Res. 2006;50(Pt 3):172-83. SOURCE DeFloria, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Avextra Portugal launches an innovative in-house breeding program to develop proprietary cannabis varieties with specific, consistent and reproducible cannabinoid and terpene profiles.Over a two-year period, a total of 5,000 seeds will be used for a comprehensive phenohunt of the Avextra cultivar. So far, 600 seeds have been utilised in the process. Led by industry experts, including former GW Pharmaceuticals Director Alan Sutton and genetics and cultivation expert Steven Tan, the program focuses on breeding proprietary plants that fulfil Avextra’s detailed specifications that are both ideal for clinical research and scalable for pharmaceutical production.This initiative is an important layer in Avextra’s IP strategy which aligns with the company’s broader commitment to advancing safe and effective cannabis-based medicines to meet complex patient needs. LISBON, Portugal, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Avextra Portugal is excited to announce that its innovative in-house breeding program is now operational. The goal of the program is to establish and stabilize plant IP for proprietary cannabis varieties in its Portuguese cultivation facility. This strategic initiative underscores Avextra’s commitment to excellence in research and development, supported by R&D cooperation partner and leading Portuguese research organization CESPU (Cooperativa de Ensino Superior Politécnico), beginning with the botanical starting material ideal for future drug formulation. Avextra’s botanical research team is led by Alan Sutton, former Director of Botanical Research at GW Pharmaceuticals, the company behind Sativex and Epidiolex—the only two cannabinoid-based medicines to receive regulatory approval in multiple regions—acquired by Jazz Pharmaceuticals in 2021. The team is also led by genetics expert Steven Tan, who has sourced unique and varied genetics with specific traits of value through his decades of experience in multiple regions around the world. Over a two-year R&D period, Avextra’s agronomic team in Portugal have germinated over 600 seeds and identified a number of unique phenotypes through chemical analysis, which have been bred to produce the specific cannabinoid ratios identified by our clinical team: Stable Major Cannabinoid Output –resulting in elevated levels of THC and CBD for consistent cannabinoid essential for effective therapeutic separations and formulations.Terpene / Phytochemical Compound Output – selection and isolation of plants with desirable terpene and phytochemical compound attributes which have the potential to deliver a low side effect profile for patients suffering from specific conditions.Optimization for Avextra’s own Cultivation Environment – the selection of botanical material has been optimized to produce a consistent output in its cultivation facility in Portugal’s Alentejo region.Extraction Efficiency – ability to deliver a unique profile after the botanical extraction processes to comprise a stable and consistent API appropriate for therapeutical use in the specific indications targeted in the company’s clinical plan. Avextra’s Portugal breeding program represents an important layer in Avextra’s IP strategy and is part of a broader commitment to innovation in the development of safe and effective cannabis-based medicines. “With this breeding program, Avextra is cultivating a key component for medicines with the potential to deliver relief to patients while offering a low side effect profile,” said Neil Smith, Chief Operating Officer at Avextra responsible for Portuguese operations. “Our goal is to meticulously breed and stabilize plant varieties unique to Avextra that set a new benchmark in therapeutic quality, safety, and efficacy. This program underscores our commitment to serving the unmet needs of a highly vulnerable patient population with the highest quality products.” About Avextra AGAvextra is one of Europe’s leading vertically integrated medical cannabis and research operators focused on the development and production of regulator-approved medicines. Founded in 2019 and based out of Germany, the company works in close collaboration with doctors and pharmacists to develop and produce precisely formulated cannabis-based medicines. Avextra controls the entire value chain – from cultivation in Portugal to EU-GMP certified extraction and manufacturing in Germany. Avextra operates across continental Europe through an expansive distribution network of multiple channels and strategically developed assets for these key markets. Avextra Investor Relations: For further information, please contact our Investor Relations Team: Email: investors@avextra.com Avextra Media Enquiries: For media enquiries or to set up an interview please contact: Email: press@avextra.com Phone: +49 30 408174037