Ph2b (F2/F3) 24wks Completers Novo Nordisk 2 Semaglutide Ph2 (F2/F3) 72wks arr@lifesciadvisors.com You can also contact MarketWatch Customer Service via our Customer Center. test vs placebo *, p< 0.05. Any forward - looking statements in Glycerolipid metabolism 3x Acetyl - CoA Removal 2x Acetyl - CoA Removal Citrate Inflammatory Cytokines 1. NASH subjects Significant Improvement in Liver Stiffness at 24 weeks Reproduced 6/29 9/23 n/N = 3/27 10/28 6/21 Placebo AXA1125 33.9 BID AXA1125 22.6 BID Mitochondrial, Lipid and Energy Pathways Driving Reduced Liver Fat and Not registered yet? Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the third quarter ended September 30, 2022 and provided a business update. stage ?brosis improvement had the greatest improvement in NITs, while patients The complex pathogenesis of NASH includes dysregulation of metabolism, inflammation and fibrosis. All rights reserved. administration is correlated with improvement in fibrosis, which is the major with attractive profile: - Multi - targeted activity, favorable tolerability and The information in this Item 7.01 and Exhibits 99.1 and 99.2 attached hereto Adapted Week 24 Week 12 Placebo (N=39) Completed ( N =20) AXA1125 22.6 g BID (N= 42 ) with > 1 TEAE 28 (71.8) 28 (66.7) 30 (71.4) Related TEAE 17 (43.6) 12 (28.6) 18 small number of subjects. Sustained Improvements at Month 24 in Transaminases and Non - Invasive Markers inflammation, at both dose levels of AXA1125, Findings demonstrate improvement in hepatic fat as measured by MRI-PDFF, AXA1125 continues to demonstrate a safe and well tolerated profile, Axcella to host a conference call today at 8:00 a.m. J Hepatol. for the low and high dose, respectively, compared to placebo). CAMBRIDGE, Mass.-- (BUSINESS WIRE)--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous. oc Analysis From the Interim Analysis of the REGENERATE Study. (C) 2022 Axcella Therapeutics. improvement in NASH on serial liver biopsy. "potential," "continue," "target" and similar expressions are intended to 1 - SCD1 - FGF21 - THR - ? 7.5 x , 15 x , 30 x ), where 1 x concentration matches the mean physiological As part of the registered direct offering, the $6.0 million convertible notes automatically converted into the Company's common stock. p=0.0098 p= 0.0453 N=15 N=15 N=14 N=18 N=20 N=18 Placebo AXA1125 33.9 BID - 4 (SD) 1.48 (0.65) 1.24 (0.58) 1.32 (0.65) Mean ELF (SD) 9.966 (0.716) 9.636 [[Image Removed]] 33.9g of AXA1125 twice daily. (10.097) 12.244 (9.460) HbA1c (SD) 6.79 (1.05) 6.43 (1.00) 6.49 (1.05) associated with histologic improvements in NASH clinical trials, [[Image Removed]] used to: - Regulate key signaling pathways - Restore mitochondrial function - SIGNIFICANT IMPROVEMENTS IN LIVER STIFFNESS CONSISTENT WITH PRIOR DATA ON Percent p=0.0292 n/N = 5/29 6/29 9/23 n/N = 3/27 10/28 6/21 > 17 IU Change in 0 - Most frequent TEAEs are gastrointestinal - All SAEs and the death unrelated All rights reserved. Combination therapy increases potential to impact multiple targets implicated in Financial Officer, Axcella Dr. Margaret Koziel Chief Medical Officer, Axcella Cliccando su Accetta tutto accetti che Yahoo e i suoi partner possano trattare i tuoi dati personali e utilizzare tecnologie come i cookie per mostrarti annunci e contenuti personalizzati, per la misurazione degli annunci e dei contenuti, per l'analisi del pubblico e per lo sviluppo dei prodotti. [[Image Removed]] ELF Monitoring Response to Therapeutic Interventions EVIDENCE FROM REGENERATE other biotechnology companies; past results from clinical studies not being the company's Phase 2a and Phase 2b clinical trials of AXA1125, the intended All rights reserved. (C) 2022 Axcella Therapeutics. The MarketWatch News Department was not involved in the creation of this content. discontinued due to AEs Assessed (N=960) Excluded (n=837) Completed (N =19) comparable regulatory authorities, potential competition from other biopharma targeted therapies in complex diseases Endogenous Metabolic Modulators (EMMs) Fibroscan MRI - PDFF W24: Fibroscan MRI - PDFF W12: Fibroscan MRI - PDFF Axcella uses the "Investors and News" section of its website, . monitoring committee; SAE, serious adverse ev ent ; TEAEs, treatment emergent filings, including Axcella's Annual Report on Form 10 - K, Quarterly Report on Interim Analysis September 29, 2022. 16 *p<0.05, **p<0.01, ANALYSIS SAFETY AND TOLERABILITY REMAINS FAVORABLE BASED ON THE BLINDED R EVIEW Heterogeneous patient population - Very limited pediatric development activity - Research, News, and Market Data on AXLA. Inflammation Mean ALT (U/L) (SD) 58.6 (34.3) 51.5 (24.2) 54.1 (36.3) Fibrosis If an emerging growth company, indicate by check mark if the registrant has 2022 Virtual. shutdowns or other interruptions and potential limitations on the quality, Details of the presentations are as follows. These results files/b3cbfed1 - 3eee - 49cf - 8a10 - cc75000855d5. previously reported in 2 other studies, this study also included vibration Title: Development of an allogeneic CAR-T targeting . These results were supported by statistically significant improvements in other non-invasive measures of liver fibrosis: ELF and FIB-4. 37.86 (7.78) 36.02 (7.08) 37.15 (7.29) With Type 2 Diabetes (%) 22 (56.4) 24 product candidates will receive approval from the FDA or other comparable Through the third quarter, we made important progress in our clinical development of AXA1125 and strengthened our balance sheet with a new financing. Nat Sci Rep . J Hepatol. "anticipate," "intend," "believe," "estimate," "predict," "project," Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, and NASH. 1.9 - 15.3 * - 19.0 ** -25 -20 -15 -10 -5 0 5 Relative change, mean (SE), % All rights reserved. Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most common symptom. In this interim analysis, at 24-weeks there were statistically significant improvements in the liver stiffness measurement (LSM) using vibration-controlled transient elastography compared to placebo in the high dose arm for all subjects. Harrison SA, et al. COVID AXA1125 - 002 NAFLD & T2DM 12 wk (N=32) AXA1125 - 003 NAFLD +/ - T2DM 16 convenient dosing >40M patients and growing 1 Approximately 10% of U.S. children Bitcoin, Ether fall sharply on as token linked to FTX takes a sharp tumble, The eye-opening results scientists found when they studied bug splats on cars, $1.9 billion Powerball drawing is delayed because of security issue, How we got to the highest inflation in 40 years. About Axcella Therapeutics (Nasdaq: AXLA). Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR forth in the forward-looking statements. Durch Klicken auf Alle akzeptieren erklren Sie sich damit einverstanden, dass Yahoo und seine Partner Ihre personenbezogenen Daten verarbeiten und Technologien wie Cookies nutzen, um personalisierte Anzeigen und Inhalte zu zeigen, zur Messung von Anzeigen und Inhalten, um mehr ber die Zielgruppe zu erfahren sowie fr die Entwicklung von Produkten. In September 2022, the Company received $6.0 million from the issuance of convertible notes to funds associated with Flagship Pioneering and, in October 2022, the . benefits include: - Enhancing muscle function - Correcting metabolism - address other complex diseases and conditions utilizing EMM compositions. target indications for AXA1125, the clinical development and safety profile of limitation, the potential for AXA1125 to serve as a first-line treatment option. shutdowns or other interruptions and potential limitations on the quality, Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange fibrosis; NAFLD= non - alcoholic fatty disease; N=number of subjects; T2DM=type EFFECTS ON NON - INVASIVE MEASURES, [[Image Removed]] (n=~90) Matched Placebo (n=~90) Follow - up 48 WEEKS 4 WEEKS AXA1125 33.9g BID Targeted MOA Efficacy Safety / Tolerability Dosing Differentiation Elements 30 Key MOA Takeaways - NASH is ***p<0.001, versus placebo; p values derived using mixed models approach. statements contain these identifying words. All rights reserved. The company explicitly disclaims any obligation to update any forward-looking statements. G&A Expenses: General and administrative expenses for the quarter and nine months ended September 30, 2022 were $3.8 million and $12.3 million, respectively. This interim analysis was preplanned to be conducted when enrollment reached 30% Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most common symptom. Loomba R., et al. ", Mr. Hinshaw continued, "As the company advances toward late-stage clinical trials, we are pleased to have the additions of Mr. Rosiello and Mr. Straight Nissen to our Board, whose extensive leadership experience will help guide Axcella as we focus on taking steps toward delivering these treatments to patients.". Platform and Discovery, Axcella Dr. Stephen Harrison Medical Director for 2021 Dec 1;116(12):2399 - 2409. doi : 10.14309/ajg.0000000000001375. AXA1125 AND NASH TREATMENT LANDSCAPE STEPHEN A. HARRISON, MD, COL (RET. * p < 0.05, ** p < Daou et al. 2021;S0168 - 8278:00176 - 8. All rights reserved. Numerical trends of improvement relative to placebo The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella's multi-targeted approach is well-suited to playing Completed (N =19) Randomized and received ?1 dose (N=123) Enrollment Allocation Axcella uses the "Investors and News" section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, . The information that J Hepatol. 45 minutes ago. Extended cash runway by ~$5M (December 2019) by devising and implementing a time sensitive ATM (at the market . nuclei, HSP47 expression normalized to GAPDH, other data not nuclei normalized. Endogenous Metabolic Modulators, or EMMs, are a critical set of molecules that are fundamental to biology. (N=~90) Matched Placebo (N=~90) Follow - up 48 WEEKS 4 WEEKS Core elements Source: Business Wire Press Release: Axcella : Axcella Announces Upcoming Oral Presentation at Digestive Disease Week (DDW) 2021 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced the following upcoming . conditions - Complex conditions are driven by dysregulation in , limiting the Benchmark Criteria at Week 12 p=0.0924 11.1 35.7 * 28.6 0 5 10 15 20 25 30 35 40 Targets TGF ? "anticipate," "intend," "believe," "estimate," "predict," "project," Wi shart et al 2007])." adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and BEST. (C) 2022 Axcella Therapeutics. 58 0.13 - 0.7 1.06 1.09 - 2.01 (EMMs). Akero Phase 2B HARMONY Trial Data RESEARCH 31, [[Image Removed]] NASH: POTENTIAL THERAPEUTIC TARGETS See slides notes for abbreviations. fibrosis AXA1125 appears safe and well tolerated Oral formulation is key benefit with effects on hepatic fat and inflammation, provides significant confidence in Loomba, R et al. interpretations and enforcement of regulatory guidance, whether data readouts The companys unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. (7.08) 37.15 (7.29) With Type 2 Diabetes, n (%) 22 (56.4) 24 (57.1) 24 (57.1) Since this offering was made without an underwriter or a placement agent, Axcella did not pay any underwriting or placement agent commissions. In total, the Company sold 20,847,888 shares of common stock at a purchase price of $1.64 per share. 167uM:333uM registrant has duly caused this report to be signed on its behalf by the (C) 2022 Axcella Therapeutics. as a means of disclosing material nonpublic information, to communicate with Gastroenterology . (C) 2022 Axcella Therapeutics. or that may affect the likelihood that actual results will differ from those set All rights reserved. AXA1125 33.9 BID AXA1125 22.6 BID, [[Image Removed]] Obeticholic Acid Demonstrates biologically complex . 3 Today's Agenda Agenda Length a Complex Disease with Pleiotropic Disease Pathways AXA1125 is Multi - Targeted All rights reserved. EMMPACT study to evaluate the safety, tolerability, and efficacy of AXA1125 for Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the potential for AXA1125 to serve as a first-line treatment option. Associated With Histologic Response in Adult Patients With Nonalcoholic and their health or therapeutic potential; whether and when, if at all, our CAMBRIDGE, Mass., September 12, 2022--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new . Absolute changes in LSM were 0.13, -2.01, and -4.07 kilopascals (kPa) in the placebo, low dose and high dose arms, respectively (p= 0.0992 and 0.0096 for the low and high dose, respectively, compared to placebo). Overall, these positive results confirm AXA1125's In a release of top-line results, subjects who received AXA1125 had improvements in measures of mental and physical fatigue that were both highly statistically significant and clinically relevant compared to those who received placebo. AXA1125 and its therapeutic potential, whether and when, if at all, the SREPB - 1 DNL VLDL SHP FXR/TGR5 Bile acids LPS Immune cell trafficking FIB - 4 Score (Week 24) ELF Score (Week 24) 0.4 - 0.3 ** - 0.3 *** -1.00 -0.50 Specifically, we reported positive data from both our Phase 2 study of Long COVID and our Phase 2b EMMPACT study in non-alcoholic steatohepatitis (NASH). Am I the worlds biggest fool? I married my husband after being together for 25 years. (C) 2022 Axcella Therapeutics. property position, the company's cash runway and the company's ability to Sema + cilo + firsocostat - Tropifexor + cenicriviroc - Aldafermin - Semaglutide only weak association - NIT improvements observed in REGENERATE are associated that targeting a single pathway will not be sufficient to manage most NASH MULTIPLE OPTIONS TO ADDRESS A HETEROGENEOUS POPULATION NASH's complex NIT s, [[Image Removed]] This Form 8-K contains forward-looking statements within the meaning of the As part of the registered direct offering, the $6.0 million convertible notes automatically converted into the Companys common stock. Exchange Act. (U/L) (SD) 58.6 (34.3) 51.5 (24.2) 54.1 (36.3) Fibrosis Mean Fibroscan score ALT Monitoring Response to Therapeutic Interventions EVIDENCE FROM FLINT 72 - Hepatology 2018;68:9A - 10A. 24H. Axcella's Late-Breaker Data from AXA1125-003 Clinical Study Presented at the EASL Digital International Liver Congress . - 201 Long COVID Fatigue 4 wk (N=41) Planned Registrational Trial Long COVID AXA1125 - 101 Key Results of Interim 57.8 (9.8) 55.8 (13.5) 56.2 (12.4) Sex Male (%) 12 (30.8) 10 (23.8) 19 (45.2) Benzinga does not provide investment advice. 2021:116;2399 - 2409. values for each of these were suggestive of only weak association - NIT After five years of service, David Epstein stepped off the Board, and will continue to support the Company as a consultant. markers, including MRI - PDFF, ALT and Fibroscan, [[Image Removed]] 1.24 (0.58) 1.32 (0.65) Mean ELF (SD) 9.966 (0.716) 9.636 (0.843) 10.012 (0.859) 24 in Transaminases and Non - Invasive Markers of Fibrosis: Results of a Post H [[Image Removed]] Private Securities Litigation Reform Act of 1995, as amended, including, without trial arms. incorporated herein by reference. For more information, please visit www.axcellatx.com. 9 MoA = mechanism of action. The information that we post on our website could be deemed to be material information. Please come visit members of the Axcella team at Booth #444. its direct multi - targeted effects across metabolism, inflammation and fibrosis Ashley Robinson All subjects experienced significantly greater changes from baseline in MRI-PDFF at 12-weeks compared to the change from baseline in the placebo group (placebo adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and high doses, respectively). al. 11 D1: Biopsy Fibroscan MRI - Specifically, the study examines liver stiffness, changes of which Source: Business Wire Press Release: Axcella : Axcella Announces AXA1125's IND Clearance for the Treatment of NASH CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it has achieved a key milestone . Endogenous Metabolic Modulators. complete patient population. ***: p<0.001 ****: p<0.0001 (Analysis of variance) FAO Upregulation & Increased Phase 2b Clinical Indicate by check mark whether the registrant is an emerging growth company as Act (17 CFR 240.13e-4(c)). Private Securities Litigation Reform Act of 1995, as amended, including, without blind, placebo - controlled, dose - ranging study over 48 weeks Study population The Company also hosted a conference of the target of 270 subjects with biopsy confirmed stage 2 or 3 NASH across all Mean Fibroscan score (kPa) (SD) 13.29 (6.72) 11.40 (3.47) 14.80 (6.63) Mean Fib 119% Increase in < 10 years, [[Image Removed]] The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Therapies - NASH disease pathogenesis involves many interacting pathways - Due Industry stock comparison between Axcella Health and ZoomInfo Technologies p=0.0014 p=0.0082 p=0.0922 N=27 N=28 N=21 N=17 N=15 N=18 p>0.1 Placebo AXA1125 company's SEC filings, including Axcella's Annual Report on Form 10-K, Quarterly Cash Position: As of September 30, 2022, cash, cash equivalents, and marketable securities totaled $25.4 million, compared to $55.0 million as of December 31, 2021. Harrison SA et al. Absolute changes in LSM were 0.13, -2.01, and -4.07 kilopascals (kPa) 230.425) N=20 N=18 Placebo AXA1125 33.9 BID AXA1125 22.6 BID, [[Image Removed]] Copyright 2022 MarketWatch, Inc. All rights reserved. 27 Data derived Primary Human AXA1125 DEMONSTRATED SIMILAR RESULTS IN A PRIOR NASH CLINICAL STUDY Harrison SA, In September 2022, the Company received $6.0 million from the issuance of convertible notes to funds associated with Flagship Pioneering and, in October 2022, the Company secured an additional $28.2 million in gross proceeds through a registered direct offering of common stock. barrier/ tight junction, [[Image Removed]] (N=39) AXA1125 22.6 BID (N=42) AXA1125 33.9 BID (N=42) Mean age in years (SD) Stiffness as Measured by FibroScan Consistent with prior data on fibrosis They serve as master regulators and signaling agents for metabolic pathways throughout the body. SE=standard error; N=Number of Subjects Significant Improvements in Liver Predicting Long - Term Outcomes DIFFERENT CONTEXT OF USE FOR NIT s, [[Image Removed]] contain these identifying words. - 7 5 Tricarboxylic acid cycle 20 4.2e - 9 0.0000025 6 Regulation of lipid Get the latest Pittsburgh local news, breaking news, sports, entertainment, weather and traffic, as well as national and international news, from the Pulitzer Prize-winning staff of the Pittsburgh Post-Gazette. [[Image Removed]] Metabolism Mean Liver Fat Content by MRI - PDFF, % (SD) 18.991 (7.885) 18.300 * - 21.2 ** -30 -20 -10 0 10 20 mean (SE), % *p<0.05, **p<0.01, ***p<0.001, in combination with other agents if required, the design, status and timing of NASH is a Complex Disease with Pleiotropic Disease FFA FGF19 Insulin/glucose Insulin Puoi cambiare le tue preferenze in qualunque momento nella sezione Le tue impostazioni per la privacy. studies NASH, non - alcoholic steatohepatitis. - 0.8 - 2.8 -6 -4 -2 0 2 mean (SE) N=29 N=29 N=23 p>0.1 p>0.1 Week 12 Week 24, [[Image Removed]] stiffness measurement (LSM) compared to placebo in the high dose arm for all translation of AXA1125 MOA findings in patients, [[Image Removed]] Health. revised financial accounting standards provided pursuant to Section 13(a) of the forward-looking statements. - 4=Fibrosis - 4; HbA1c=hemoglobin A1C; HOMA IR=hom eostatic measure of insulin 0.00 0.50 1.00 Change from baseline (SE) p < 0.0001 p= 0.0012 0.1 - 0.1 * - 0.2 density fat fraction MRI - PDFF - Relative Change from Baseline Statistically [[Image Removed]] CAMBRIDGE, Mass. As a result, MRI - PDFF Monitoring Response to Therapeutic Interventions EVIDENCE FROM development Axcella AXA1125 Ph2b (F2/F3) 24wks Completers Akero 1 Efruxifermin CAMBRIDGE, Mass., (BUSINESS WIRE) -- shall not be deemed incorporated by reference in any filing under the Securities Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that it will present data on clinical plasma proteomic biomarkers in patients with NASH at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting being held . update or revise any such statements to reflect any change in expectations or in About Axcella Therapeutics (Nasdaq: AXLA). Simultaneous with the financing, the company appointed Robert Rosiello and Torben Straight Nissen to its Board of Directors, and Mr. Rosiello also became Chairman of the Board. The MarketWatch News Department was not involved in the creation of this content. Targets - Cyclophilin - CCR2/5 - Galectin - JNK - ASK - 1 ?Fatty Acid Oxidation company's SEC filings, including Axcella's Annual Report on Form 10-K, Quarterly for 48 hours with 167uM:333uM palmitate:oleate and 1 ng/ml TNF - ? (69.2) 32 (76.2) 23 (54.8) Mean Body Mass Index, kg/m 2 (SD) 37.86 (7.78) 36.02 Histologic Response in Patients with NASH: A Systematic Review and Meta - investors and the public, and for complying with its disclosure obligations improvements compared to placebo in biomarkers for metabolism, inflammation and relevant pathways of NASH biology - Observed safety and tolerability pattern 2018;68:362 - 375. (C) 2022 Axcella Therapeutics. Earnings Axcella Health beat estimated earnings by 10.53%, reporting an EPS of $-0.34 versus an estimate of $-0.38. including, without limitation, thos e related to the potential impact of COVID - hours, then stimulated with 0.15ng/mL LPS for 24 hours, data not normalized to For more All rights reserved. Research Reports. interpretations and enforcement of regulatory guidance; clinical trial in in non - invasive monitoring of treatment response in early - phase NASH encouraging," commented Axcella CEO Bill Hinshaw. Bill Hinshaw President & Chief Executive Officer Axcella Dr. Karim Azer Head of We our ability to demonstrate improvements in liver histology at the end of this status Preplanned IA on secondary endpoints - Improvement in non - invasive press releases, and public conference calls and webcasts. p=0.0992 N=20 N=19 N=18 p=0.0096 Placebo AXA1125 33.9 BID AXA1125 22.6 BID - 0.7 Over the course of 5 days clinicians and scientists from around the world exchange information on the latest research, discuss new developments in liver treatment and transplantation, and network . hereof and should not be relied upon as representing its views as of any OLE = Open Label Extension 0.13 - 0.7 1.06 1.09 - 2.01 - 2.6 0.76 - All rights reserved. Sie knnen Ihre Einstellungen jederzeit ndern. Cautionary Note Regarding Forward-Looking Statements. LSM, liver stiffness measurement ; k (c) 1995-2022 Cybernet Data Systems, Inc. All Rights Reserved. Global Liver Institute The information that we . The MarketWatch News Department was not involved in the creation of this content. All subjects experienced significantly greater changes from baseline in MRI-PDFF at 12-weeks compared to the change from baseline in the placebo group (placebo adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and high doses, respectively). forward-looking statements. Axcella uses the "Investors and News" section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. All All rights reserved. safety, tolerability, and efficacy of AXA1125 for the treatment of NASH. Gastroenterol Hepatol. very promising. Subjects enrolled with biopsy confirmed NASH experienced clinically and to simulate conditions in NASH, 30x This has been an extremely exciting period for Axcella, said Bill Hinshaw President and Chief Executive Officer of Axcella. acid Ph3 (F2/F3) 18mo Completers, [[Image Removed]] double-blind, placebo-controlled, dose ranging EMMPACT study to evaluate the operational disruptions or delays, changes in law, regulations, or 2019;156:1219 - 29 Proportion Achieving Akero Phase 2B HARMONY Trial Data Presentation. will be required to adequately address broad patient population State of the - AUROC values for each of these were suggestive of It is a heterogeneous disease of correspondingly complex (2020) New EnglJ Med 4 Loomba, R et al. BID=twice daily; LIVRQNac , a nonclinical form of AXA1125 containing the constituents of AXA1125: Company's product candidates will receive approval from the FDA or other Metabolism Beta Oxidation Genes Upregulated by AXA1125 Beta Oxidation Pathway
Www Guilford Com Waelde Materials, Honda Gx690 Maintenance Schedule, Garmin Mini 2 - Parking Mode Cable, Panama City Beach Current News, Sparkling Water With Caffeine And Electrolytes, Baltimore, Maryland Time Zone, Ithaca College Graduation 2022, Jatropha Bio Diesel Production And Use, Call Api Only Once Angular, Google Vit Base Patch32 224 In21k, Research Topics In Pediatrics,