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RESEARCH TRIANGLE PARK, N.C.--( BUSINESS WIRE )--Evecxia Therapeutics—the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS disorders—today announced Dr. Jacob Pade Ramsøe Jacobsen , the Co-Founder & Chief Executive Officer of Evecxia Therapeutics, Inc. , will be presenting at the ACCESS CHINA Partnering Forum – Autumn Virtual Showcase during September 24th to 25th, and 27th, 2024. Link to ACCESS CHINA. About Evecxia Therapeutics Evecxia is the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS disorders. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression and obsessive-compulsive disorder (OCD) when first-line serotonin reuptake inhibitor (SSRI/SNRI) antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy for patients hospitalized for acute suicidal crisis. For additional information about Evecxia, please visit www.evecxia.com .

RESEARCH TRIANGLE PARK, N.C.--( BUSINESS WIRE )--Evecxia Therapeutics—the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS disorders—today announced the filing of a provisional patent on chemical synthesis of 5-hydroxytryptophan (5‑HTP). 5-HTP is the natural immediate precursor of the neurotransmitter serotonin. Decades of clinical reports support a consensus that 5-HTP has demonstrated therapeutic potential in mood and others CNS disorders (1-3). 5-HTP has a benign human safety record (2, 4). 5-HTP’s putative therapeutic action is via Serotonin Synthesis Amplification, creating a stronger, more resilient brain serotonin system, a pharmacology distinct from available serotonin drugs, e.g., serotonin reuptake inhibitors and psychedelics. But the 5-HTP molecule is impractical for clinical practice, as 5-HTP is minimally absorbed by the body and very short-acting (5). Evecxia deploys pharmaceutical technologies to ensure sufficient absorption and prolonged action of 5-HTP in the body, thus enabling practical Serotonin Synthesis Amplification therapy. Today, available 5-HTP is extracted from Griffonia simplicifolia , harvested in the wild in West Africa. Griffonia cultivation attempts have failed. Habitat degradation and overharvesting may threaten future botanical 5-HTP supply (6). To ensure future 5-HTP supply and control its quality and manufacture, Evecxia has developed a novel and simple chemical synthesis process for 5-HTP, comprising steps consistent with scalability to commercial drug substance manufacture. A provisional patent has been filed protecting the process and chemically synthesized 5-HTP. Jacob Jacobsen, Evecxia's CEO, stated, "Risk-mitigation is Evecxia's lodestar. We are pleased we successfully established proof-of-concept for securing future 5‑HTP drug substance supply. Patents pertaining to drug substance manufacture and solid forms are critical in pharmaceutical intellectual property. The new patent would augment Evecxia's portfolio of issued and pending patents, which we expect to protect our drug candidates EVX-101 and EVX-301 well into the 2040s." About Evecxia Therapeutics Evecxia is the first company dedicated to realizing the therapeutic potential of Serotonin Synthesis Amplification to treat CNS disorders. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression and obsessive-compulsive disorder (OCD) when first-line serotonin reuptake inhibitor (SSRI/SNRI) antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy for patients hospitalized for acute suicidal crisis. For additional information about Evecxia, please visit www.evecxia.com . References 1. Shaw K, et al. (2002): Cochrane Database Syst Rev.CD003198. 2. Turner EH, et al. (2006): Pharmacol Ther. 109:325-338. 3. Levy A, et al. (2016): Curr Treat Options Neurol. 18:21. 4. Das YT, et al. (2004): Toxicol Lett. 150:111-122. 5. Evecxia (2024): Data on file. 6. Cunningham AB, et al. (2021): J Ethnopharmacol. 278:114202.

AD04 reduced heavy drinking days among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as identified by a companion diagnostic test (CDx) June 20, 2024 -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced the publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, “Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes.” The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company’s lead asset, AD04 (low-dose ondansetron), and the placebo group among heavy drinking patients with Alcohol Use Disorder (AUD) and specific genotypic variants. AD04 significantly decreased the monthly percentage of heavy drinking days after 6 months of treatment among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as determined via a CDx This genotypic profile is in the serotonin transporter and serotonin-AB receptor complex AD04′s adverse events (AEs) match those of the placebo Combining AD04 with psychosocial intervention may change favorably how AUD disease is perceived and increase the demand for treatment to many who not have otherwise considered it “The findings highlighted in the publication underscore the promise of AD04, with incorporation of a CDx, as an important advancement in the field of precision medicine. This approach is critical as AUD can be caused by a variety of gene-environment interactions and does not manifest uniformly across all patients,” said Cary Claiborne, CEO of Adial. “We believe patients struggling with AUD stand to gain greater benefit from precision treatments to reduce alcohol consumption such as AD04, as opposed to a one size fits all approach. Recognizing the benefits of AD04 within this genetically and behaviorally defined patient population will allow Adial to continue developing a 21st-century-based approach to the treatment of this devastating disorder. AD04 offers a novel strategy to manage AUD by reducing the potential harm of AUD, while lowering the perceived stigma of personal failure associated with the disorder.” The study examined the role of endophenotypes in predicting AD04’s efficacy for the treatment of AUD and found that specific genotypes affecting the serotonin transporter and serotonin-AB receptor complex are predictive of AD04’s ability to reduce the number of heavy drinking days among patients with AUD. In particular, the data revealed that individuals with specific genetic backgrounds and meeting the criteria to be defined as “heavy drinkers” (avg. <10 drinks per drinking day) saw a reduction in the monthly percentage of heavy drinking days after 6 months of treatment. Additional analysis revealed that patients treated with AD04 experienced minimal AEs which were comparable to placebo treatment, high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. The content above comes from the network. if any infringement, please contact us to modify.