Evecxia Therapeutics, Inc.
生物技术
Research Triangle Park，NC 468 位关注者
Harnessing the full therapeutic potential of serotonin synthesis amplification for the treatment of mental illness.
关于我们
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 crisis. Evecxia holds a comprehensive portfolio of issued and pending patents on the 5-HTP sustained-release/serotonin amplification method, doses, formulations, and related technologies.
- 网站
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www.evecxia.com
Evecxia Therapeutics, Inc.的外部链接
- 所属行业
- 生物技术
- 规模
- 2-10 人
- 总部
- Research Triangle Park，NC
- 类型
- 私人持股
- 创立
- 2013
地点
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主要
获取路线
US，NC，Research Triangle Park
Evecxia Therapeutics, Inc.员工
动态
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?????? ???? ?????????????????????????????? ??????????????? ?????????????? ?????????? ????: ? ???????????????? ??????????????????: 100% of marketed antidepressants are based in clinical evidence?? ? ???????? ????????????: SSRIs have same MOA and no better efficacy as the tricyclic antidepressants from the 1950s. Yet, SSRIs became blockbusters because better safety allowed for wider prescription, even by primary care doctors, who prescribe ~80% of antidepressants ? ? ?????????????????????? ???? ???????? ??????????????????????: The atypical antipsychotic Abilify? sold ~$2b/y for adjunctive antidepressant therapy, due to?proven?added efficacy vs SSRI alone, despite prescription by psychiatrists only ?? ? ???????????????????? ???? ?????????????????????????????? ???????? ??????????:?Like SSRIs, the primary pharmacology of Trintellix?, Auvelity?, Effexor?, and Cymbalta? is serotonin reuptake inhibition. Clinical evidence these drugs treat SSRI poor responders is minimal. Yet, they sell - on the?perception?of differentiation from SSRIs ? ? ???? ???????? ????????????:?Brain stimulation and IV/IN ketamine treat many poor responders to SSRIs; yet, in-clinic administration and high price limits access.?Psychiatry is in a dire resource shortage. E.g., less than 20% of psychiatrist accept new patients, average wait for an appointment exceeds 2 months, and reimbursement is low. At home oral antidepressants are the only scalable ?? ? ???????????????? ??????????????????????: The commercial success of SSRIs (depression, OCD, anxiety, PTSD) and Abilify? (psychosis, depression, bipolar, autism) were augmented by multiple indications ? ?? Adjunctive???????-?????? from Evecxia is a????????????? ??and based in a????????????????? ?????????????????? ? for??????????????????????? ???? ???????? ? monotherapy; appears??????????? and could??????????? ??even to?primary care prescription;?and could treat????????????????? ?????? ?????????????????????? ?, prominently ????????????????????, ??????, anxiety disorders ?
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Evecxia Therapeutics to Speak at ACCESS CHINA Partnering Forum September 18th, 2024 (Shanghai) — We are glad to announce that Dr. Jacob Pade Rams?e 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. https://lnkd.in/gGcErq9v
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?? Good?SAFETY?supports widespread adoption and?commercial success?for antidepressants ? ?? SSRIs were phenomenally successful because good SAFETY enabled widespread prescription - including by family doctors, who prescribe ~75% of antidepressants ? ?? In contrast,?SAFETY CONCERNS?(e.g., atypical antipsychotics) and/or need for?specialized clinics?(e.g., ketamine, psychedelics)?curtail the use?of current next-line antidepressants ?? ?? Evecxia’s next-line antidepressant candidate?EVX-101?(5-HTP/low-dose carbidopa sustained-release) exhibited?EXCELLENT SAFETY?in Phase 1 and in GLP non-clinical toxicology ? 5-HTP’s human SAFETY RECORD since the 1960s (PubMed, FDA, NIH). ??0?– Number of deaths reported. ??0?– Number of serious adverse events ascribed. ??0?– Number of published reports on serotonin syndrome. ??>150?– Number of published clinical studies. ? Scleroderma was reported in a patient taking high doses of 5-HTP and carbidopa; but, was ascribed to high-dose carbidopa rather than 5-HTP, or to other causes?(1). Everything—including water, salt, and pretzels—is toxic; at high doses; in some subjects ?? ? The totality of data suggests?EVX-101 in clinical practice would have EXCELLENT SAFETY. This, together with anticipated superior efficacy versus SSRIs alone, could support widespread adoption of EVX-101, and eventually frequent prescription also by family doctors ???? ?? EVX-101 could emerge as the most IMPACTFUL MOOD DISORDER THERAPY since Prozac was approved in 1987?? References 1.?????????Sternberg EM, et al. (1980):?The New England journal of medicine. 303:782-787.
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New Patent Filed Augments Evecxia's Already Strong Portfolio of Issued and Pending Patents. ?? Patents on drug substance manufacture and solid forms are critical in pharmaceutical IP and listable in FDA’s Orange Book. Such patents can block ANDA generic filers - and extend branded drug exclusivity for a decade.? ?? Prior art in the 5-HTP chemical synthesis space is minimal; freedom-to-operate is excellent. ?? We expect the filed patent to form the keystone of a new patent estate, forming yet another concentric IP wall shielding Evecxia’s drug candidates well into the 2040s??.
Evecxia Therapeutics Files Patent for 5-hydroxytryptophan (5-HTP) Chemical Synthesis
businesswire.com
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OBSESSIVE-COMPULSIVE DISORDER (OCD) ? The greatest overlooked unmet need in Psychiatry? Next-line OCD therapy is one of the largest commercial opportunities in Psychiatry, with the least competition - and a space Evecxia’s Phase 2-ready drug candidate EVX-101 could own. BACKGROUND: At any time, Obsessive-Compulsive Disorder (OCD) affects 1.2 % of the population (NIH). Obsessions and compulsions dominate the patient’s life, often causing distress and impairment of similar magnitude to Schizophrenia (Hirschtritt 2017). Two-thirds of OCD patients are substantially disabled. OCD is chronic and requires long-term treatment (Stein 2019). SSRIs are first-line in OCD, but 50% responds inadequately (Hirschtritt 2017). There are no FDA-approved next-line drugs for OCD. No new OCD drugs have been FDA-approved since the SSRIs in the 1990s.?Roche?and?Novartis?pursued next-line OCD drugs, but failed. Only?Biohaven?has a current OCD program. RATIONALE FOR EVX-101:?OCD symptoms are uniquely responsive to serotonin. Elevating brain serotonin activity beyond the effect of standard SSRI doses augment clinical efficacy (Hirschtritt 2017;?Rasmussen 1984). Thus, adjunctive EVX-101 could augment efficacy in OCD patients responding inadequately to SSRI therapy and become the first FDA-approved next-line OCD drug. PHASE 2 RISK-MITIGATION : In addition to the clinical basis for EVX-101, OCD trials are risk-mitigated due to 60% lower placebo response than in depression trials (Bschor 2024). References 1. Hirschtritt ME, et al. (2017):?Jama. 317:1358-1367. 2. Stein DJ, et al. (2019):?Nat Rev Dis Primers. 5:52. 3.?Rasmussen SA (1984):?Am J Psychiatry. 141:1283-1285. 4.?Bschor T, et al. (2024):?JAMA psychiatry.
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How Are New Antidepressants Discovered? ? Animal behavioral models of depression = 0% ? ? Clinical pilot data and serendipity = 100% ? Yes, 100% of marketed antidepressants are based in clinical data 40 years, 10,000s of research papers, $Bs of research funds, dozens of compounds and clinical trials... Not one antidepressant candidate based in animal antidepressant-like behavioral models ever succeeded in clinical trials and made it to market. How were marketed antidepressants discovered? ? MONOAMINE OXIDASE INHIBITORS (MAOIs): Iproniazid, a tuberculosis drug, was observed to cause antidepressant effect in depressed tuberculosis patients, in the 1950s. ? TRICYCLIC ANTIDEPRESSANT (TCAs): Imipramine, a failed antipsychotic, surprised by treating depression in psychotic depressed patients, in the 1950s ??TETRACYCLIC ANTIDEPRESSANTS: Chemical derivatives of the TCAs, in the 1960s. ??BUPROPION: Small clinical study from the 1960s. ??SSRIs, e.g., Prozac: Inspired by TCAs + clinical data indicating that serotonin was the main antidepressant pharmacology, in the 1970s-80s. ??SNRIs, e.g., Inspired by SSRIs and TCAs, in the 1990s. ??ATYPICAL ANTIPSYCHOTICS: Pilot studies in depression with Clozapine, in the 1970s. ? KETAMINE: Serendipity + inspiration from clinical observations of glutamatergic dysfunction in depression patients, in the 1990s. ??GABA PAMs. Serendipitous observations from the 1950s. Thus, as scientists—and recipients of federal grants and investor funds—it behoves us to spend our time and other people's money to hunt for new antidepressant candidates based in clinical data.
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Safe, Effective, and Convenient Outpatient Therapies are Needed to Make a Real Impact on the Mental Health Crisis in the US. ? US mental health care is under-resourced? ? Median wait to see a Psychiatrist exceeds two months? ? >80% of Psychiatrists don't accept new patients? ? Reimbursement rates for newer expensive therapies are low? Brain stimulation and psychedelic-assisted psychotherapy are life-changing for some. But high price limits access to a minority of the sickest (and wealthiest) patients... EVX-101 could treat depression, OCD, and other mood disorders responding inadequately to first-line SSRI/SNRI antidepressants ? Evecxia's drug candidate EVX-101 would be taken at home, have no abuse potential, and be safe ? EVX-101 could become a critical tool in general clinical practice to address the US mental health care crisis - at scale, for the average patient ?? (Message me if no access to the paper) https://lnkd.in/dG4ry-BD
Low availability, long wait times, and high geographic disparity of psychiatric outpatient care in the US
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