Evecxia, Inc.

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat neuropsychiatric disorders, today announced the appointments of Allan L. Shaw and Elliot Ehrich, MD to its Board of Directors, bringing with them decades of leadership experience in the biopharmaceutical industry. “We welcome Allan and Elliot to our team. We are excited to draw on their impressive backgrounds as we continue to progress Evecxia’s drug candidates through clinical development and towards commercialization,” said Jacob Jacobsen, PhD, Chief Executive Officer of Evecxia Therapeutics. “Allan’s financial and deal-making expertise and Elliot’s track record of developing CNS drugs, from research through approval, will position Evecxia well going forward, as we advance our drug candidates EVX-101 and EVX-301 into Phase 2 clinical trials and continue to further build out the Company.” “Evecxia is at an important stage of growth, and I am thrilled to help advance the Company’s groundbreaking drug candidates to improve outcomes for patients suffering from treatment non-responsive depression and suicidal ideation, representing huge unmet medical needs and large market opportunities,” stated Mr. Shaw. “I look forward to working with the Evecxia team and Board to help execute on the Company’s strategic goals and maximize shareholder value.” “Evexcia’s differentiated approach to enhance serotonergic tone has the potential to uniquely benefit the large proportion of patients with depression who remain symptomatic despite being treated with currently available treatments,” stated Dr. Ehrich. “I look forward to serving on the Board and working with the Evecxia team to advance the clinical development and realize the therapeutic promise of EVX-101 and EVX-301.” Mr. Shaw brings to Evecxia more than 20 years of leadership experience managing public companies from financial, operational and strategic global business perspectives. He currently serves as the Chief Financial Officer of Portage Biotech and has served on seven public boards including chairing three audit committees and three compensation committees. Mr. Shaw is also a five-time public company Chief Financial Officer and an experienced deal executive, who has structured, directed, negotiated, and closed over $4 billion in public and private financings, for several companies, including several IPOs. Mr. Shaw received a B.S. from the State University of New York at Oswego and is a Certified Public Accountant in the state of New York as well as a Chartered Global Management Accountant. Dr. Ehrich is currently Executive Vice President and Chief Medical Officer at LifeMine Therapeutics. Prior to LifeMine, Dr. Ehrich was President of Skyhawk Therapeutics and a Venture Partner at 5AM Ventures. From 2000 to 2018, Dr. Ehrich was at Alkermes. Over this span of 18 years, he rose through the ranks to lead all research and development activities at Alkermes. As Executive Vice President of Research & Development and Chief Medical Officer, Dr. Ehrich initiated a transformation of Alkermes’ R&D focus from medicines based on drug delivery technology to a diverse portfolio of novel, proprietary small molecule therapeutics. In doing so, he led the discovery, development, and, ultimately, the FDA registration of a series of medicines for multiple therapeutic indications, including schizophrenia, alcohol and opioid dependence, and multiple sclerosis. Prior, Dr. Ehrich spent 7 years at Merck Research Labs working in clinical pharmacology and clinical development. Dr. Ehrich received a B.A. at Princeton University and an M.D. from Columbia University. About Evecxia Therapeutics Evecxia’s mission is to help patients suffering from disabling neuropsychiatric conditions for which current therapies are inadequate. Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders. Serotonin synthesis amplification builds a stronger, more dynamic, more resilient brain endogenous serotonin system. Serotonin synthesis amplification is a distinct pharmacology from targeting serotonin transporters (e.g., serotonin reuptake inhibitors) and receptors (e.g., psilocybin). Evecxia deploys 5-hydroxytryptophan (5-HTP), the natural serotonin precursor, delivered via proprietary drug delivery technologies, to achieve sustained brain serotonin synthesis amplification. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression 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 .

- Oral EVX-101 administration over 3 months was modeled in rats and pigs co-treated with the first-line antidepressant fluoxetine. - There were no toxicological findings in either species, even at 5-HTP plasma levels 20-fold greater than the anticipated human therapeutic levels. - This reported favorable safety corresponds to the favorable safety across Evecxia’s three Phase 1 trials and the favorable safety reported with 5-HTP, the active compound in EVX-101, in over 100 published clinical studies. RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced the absence of toxicity findings associated with the co-administration of EVX-101 in conjunction with the first-line antidepressant fluoxetine in nonclinical GLP toxicology studies. These favorable results support the safety pro the lead drug candidate, EVX‑101, in a planned Phase 2 clinical trial in patients with major depressive disorder inadequately responding to first‑line antidepressant therapy. EVX‑101 is being developed as an adjunctive treatment for depression when first-line SSRI/SNRI antidepressants alone are inadequate. EVX‑101 is a patented gastroretentive sustained-release tablet formulation of 5‑hydroxytrytophan (5‑HTP), the natural immediate precursor of serotonin, and low-dose carbidopa, a peripheral L-aromatic amino acid decarboxylase inhibitor. In EVX-101, the 5-HTP dose is fixed, while the amount of carbidopa is varied to control the level of 5-HTP plasma exposure. The nonclinical GLP toxicology program was designed to assess the pharmacokinetics and systemic toxicity of oral administration of EVX-101 in conjunction with an SSRI for up to 3 months in rats and pigs. EVX‑101 tablets were administered twice daily to pigs, similar to the intended administration in humans. A formulation containing 5‑HTP and variable carbidopa amounts prepared in rodent diet was offered ad libitum to rats to simulate EVX-101 administration. Fluoxetine administration was initiated several weeks before EVX-101 initiation to model the future clinical scenario where EVX-101 will be administered adjunctively to ongoing SSRI/SNRI. Fluoxetine administration was continued for the duration of EVX-101 administration. Oral adjunctive EVX-101 for 3 months was well tolerated in both species. There were no safety findings at any parameter, even at 5‑HTP plasma levels exceeding 2000 ng/mL, 20-fold greater than the anticipated human therapeutic plasma level of about 100 ng/mL. Safety endpoints included detailed clinical observations, body weight, ophthalmic examinations, clinical pathology (serum chemistry, hematology, and urinalysis), organ weights, macroscopic organ appearance, and microscopic tissue examinations, in accordance with FDA guidance. The absence of toxicological findings in the nonclinical GLP studies are consistent with the favorable historical safety pro 5‑HTP administration across more than 100 human clinical studies conducted over the past six decades. The findings are also consistent with the absence of safety findings of concern in two Phase 1 clinical trials of EVX-101 and one Phase 1 clinical trial of EVX-301 (IV 5-HTP formulation) in conjunction with a first-line antidepressant, conducted by Evecxia to date. Hence, the totality of safety data suggest that serotonin synthesis amplification with adjunctive EVX-101 could have good safety during human therapy. “Evecxia has made great strides to advance EVX‑101 through two Phase 1 trials, which produced excellent safety, acceptable tolerability, and evidence of brain serotonin target engagement. The results from our nonclinical GLP toxicology studies strongly support our mission to bring safer and potentially more effective treatments to patients suffering from disabling neuropsychiatric disorders. We look forward to advancing EVX-101 into Phase 2 trials,” said Dr. Jacob Jacobsen, CEO and co-founder of Evecxia. About Evecxia Therapeutics Evecxia’s mission is to help patients suffering from disabling neuropsychiatric conditions for which current therapies are inadequate. Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders. Serotonin synthesis amplification is distinct from targeting serotonin transporters (e.g., SSRIs) and receptors (e.g., psilocybin). Evecxia deploys 5-hydroxytryptophan (5-HTP), the natural serotonin precursor, delivered via proprietary drug delivery technologies to achieve sustained serotonin synthesis amplification. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX‑101 is being developed as an adjunctive treatment for depression when first-line SSRI/SNRI antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy for acute suicidal crisis. For additional information about Evecxia, please visit .

Quotient Sciences' modified release capabilities enhance performance of EVX-101 NOTTINGHAM, England, Sept. 21, 2023 /PRNewswire/ -- A drug development partnership between Evecxia Therapeutics and Quotient Sciences has resulted in the successful delivery of a Phase 1 clinical testing program for Evecxia's drug candidate EVX-101, which is in development for major depressive disorder (MDD). Quotient Sciences' Translational Pharmaceutics® platform was used to develop and optimize the drug delivery mechanism of the EVX-101 technology and was a driving force behind the success of the clinical testing program. Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders like MDD. MDD is a major global health issue that affects 280 million people worldwide. As part of its work, Evecxia is currently developing EVX-101 as an adjunctive treatment for MDD because many patients experience an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). EVX-101 is a novel, proprietary, gastro-retentive, sustained-release tablet formulation of 5-hydroxytryptophan (5-HTP), the natural precursor to serotonin, and low-dose carbidopa. 5-HTP is the active compound and carbidopa functions as an absorption enhancer for 5-HTP. Drug development and manufacturing accelerator, Quotient Sciences, has extensive expertise in developing modified release technologies that can transform the drug properties of active compounds otherwise limited by restricted oral bioavailability and/or rapid elimination from the body. These technologies help balance therapeutic needs, manage adverse event profiles, and reduce dosing frequency, which contributes to improved patient compliance and often clinical effectiveness. Quotient Sciences' Translational Pharmaceutics® platform integrates formulation development and real-time manufacturing with clinical testing using an adaptive clinical study design, reducing timelines and costs, and helping to get new medicines to patients faster. Using Translational Pharmaceutics, the optimized EVX-101 formulation was further validated in Phase 1 single- and multiple-ascending-dose clinical trial in healthy volunteers taking the SSRI escitalopram and demonstrated favorable safety and tolerability, as well as pharmacokinetic and pharmacodynamic data. Evecxia will now take the new EVX-101 drug candidate into a Phase 2 adjunctive treatment study in patients with MDD who are responding inadequately to a first-line SSRI/SNRI antidepressant. Commenting on the collaborative work, Jacob Jacobsen, Ph.D., CEO of Evecxia, said: "Quotient Sciences' expertise in developing and optimizing modified release formulations coupled with their ability to integrate rapid clinical assessments allowed us to produce a new drug candidate, EVX-101, in a highly condensed time frame." "We are very pleased with the outcome of this partnership and appreciate the collaboration between both organizations to aid in the advancement of EVX-101 towards helping patients who are suffering from the life-limiting effects of MDD." Mark Egerton, Ph.D., CEO of Quotient Sciences, added: "Our partnership with Evecxia has greatly accelerated the development timeline of their EVX-101 program. Improving mental health is a global goal and the industry must work hard to get treatments to patients more quickly." "We are proud that this collaboration and our expertise has enabled Evecxia to successfully progress EVX-101 onward into Phase 2 studies to provide patients who are suffering from MDD with new treatment options." About Quotient Sciences Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, please visit quotientsciences.com. About Evecxia Therapeutics Evecxia's mission is to help patients suffering from disabling neuropsychiatric conditions for which current therapies are inadequate. Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders. Serotonin synthesis amplification is distinct from targeting serotonin transporters (e.g., SSRIs) and receptors (e.g., psilocybin). Evecxia deploys 5-HTP, the natural serotonin precursor, delivered via proprietary drug delivery technologies to achieve sustained serotonin synthesis amplification. Evecxia has two Phase 2 clinical-stage drug candidates in development. EVX-101 is being developed as an adjunctive treatment for depression when first-line SSRI/SNRI antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy for patients in acute suicidal ideation crises. Evecxia holds a comprehensive portfolio of issued and pending patents on the 5-HTP sustained-release/serotonin amplification method, doses, formulations, and related technologies. For additional information about Evecxia, please visit . SOURCE Quotient Sciences