Tolerability

Omega Therapeutics Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, August 3, 2023
OMEGA, MYC, Liver disease, OEC, G&A, NSCLC, COVID, Part, Lung cancer, Strategic planning, Messenger, Multiple, Annual general meeting, ASCO, Investigational New Drug, Patient, Standard of care, Acute respiratory distress syndrome, Regional Security System, Relative biological effectiveness, R, Research, Therapy, Tumor microenvironment, IND, Potential, HCC, Safety, Pharmaceutical industry, Tolerability, Pharmacology

Continued Enrollment in Monotherapy Dose Escalation Stage of Phase 1/2 MYCHELANGELO™ I Study; Preliminary First-in-Human Safety, Tolerability, Pharmacologic and Translational Data Anticipated in the Fourth Quarter of 2023

Key Points: 
  • Continued Enrollment in Monotherapy Dose Escalation Stage of Phase 1/2 MYCHELANGELO™ I Study; Preliminary First-in-Human Safety, Tolerability, Pharmacologic and Translational Data Anticipated in the Fourth Quarter of 2023
    CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, today announced financial results for the second quarter ended June 30, 2023, and highlighted recent Company progress.
  • Research and development (R&D) expenses for the second quarter of 2023 were $25.0 million, compared to $19.4 million for the second quarter of 2022.
  • General and administrative (G&A) expenses were $6.2 million for the second quarter of 2023 and 2022.
  • Net loss for the second quarter of 2023 was $29.7 million, compared to $25.9 million for the second quarter of 2022, driven predominantly by increased R&D expenses to support the Company’s growth.

Microba Commences Phase I Clinical Trial for IBD Therapeutic

Retrieved on: 
Wednesday, June 28, 2023
Health, Managed Care, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Autoimmune disease, GMP, Maintenance, Partnership, Drug development, Bleeding, IBD, Tolerability, Clinical trial, Pharmacokinetics, ASX, Multimedia, Inflammation, Diarrhea, Ulcerative colitis, LBP, US, UC, Patient, Cancer, Drug discovery, Conditional sentence, Inflammatory bowel disease, Ulcer, FDA, Therapy, SVP, Disease, MAP, Pharmaceutical industry, Safety

Microba Life Sciences Limited (ASX: MAP) (“Microba” or the “Company”) today announces that the first participants have been successfully dosed in the Phase I Clinical Trial of MAP 315, in Microba’s Therapeutic Program in Inflammatory Bowel Disease (IBD).

Key Points: 
  • Microba Life Sciences Limited (ASX: MAP) (“Microba” or the “Company”) today announces that the first participants have been successfully dosed in the Phase I Clinical Trial of MAP 315, in Microba’s Therapeutic Program in Inflammatory Bowel Disease (IBD).
  • (Photo: Business Wire)
    Professor Trent Munro, SVP of Therapeutics at Microba said: “Microba has now matured into a clinical stage drug development company.
  • The clinical trial is titled “A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MAP 315 in Healthy Adults”.
  • Microba has established three therapeutic programs spanning IBD, Immuno-Oncology and Autoimmune Diseases, with lead candidate MAP 315 under the Company’s IBD program the first program to enter human clinical trials.

Mozart Therapeutics Presents Preclinical Data for MTX-101, a Novel CD8 Treg Network Modulator for Treatment of Autoimmune Disease, at FOCIS 2023 Annual Meeting

Retrieved on: 
Wednesday, June 21, 2023
Tolerability, Tissue, Poster, Cytokine, Federation, Therapy, Abstract, Wolfgang Amadeus Mozart, Blood, Annual general meeting, Pharmaceutical industry

SEATTLE, June 21, 2023 /PRNewswire/ -- Mozart Therapeutics , a leading developer of CD8 Treg Modulators for the treatment of autoimmune and inflammatory disease, today announced the presentation of preclinical pharmacologic and tolerability data for MTX-101, a bispecific autoimmune checkpoint inhibitor, at the Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS 2023).

Key Points: 
  • SEATTLE, June 21, 2023 /PRNewswire/ -- Mozart Therapeutics , a leading developer of CD8 Treg Modulators for the treatment of autoimmune and inflammatory disease, today announced the presentation of preclinical pharmacologic and tolerability data for MTX-101, a bispecific autoimmune checkpoint inhibitor, at the Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS 2023).
  • MTX-101 selectively acts on CD8 Treg in blood and tissues and does not cause activation of other immune cells nor an increase of pro-inflammatory cytokines;
    MTX-101 possesses a favorable and antibody-like pharmacokinetic profile.
  • The poster "Pre-clinical Pharmacologic and Tolerability Characterization of MTX-101, a Novel KIR x CD8 Targeting Bispecific CD8 Treg Modulator" (Abstract #1517124) can be accessed from the Mozart Therapeutics website .

Pulmatrix Presents PUR3100 Phase 1 Data at the 65th Annual Meeting of the American Headache Society

Retrieved on: 
Thursday, June 15, 2023
Ph2, Tmax, Partnership, IV, Safety, Pharmacokinetics, Cmax, DHE, Migraine, Patient, AUC, Poster, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry, Tolerability

The poster showcases data from the Phase 1 study of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine in 26 subjects, ages 18-49 years.

Key Points: 
  • The poster showcases data from the Phase 1 study of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine in 26 subjects, ages 18-49 years.
  • PUR3100 was generally well tolerated with fewer TEAEs in PUR3100-treated groups than in the IV DHE-treated group.
  • The Phase 2 study would assess the safety and effectiveness of two dose levels of PUR3100.
  • Pulmatrix is exploring partnership opportunities as a potential path forward for the Ph2 study."

Ascendis Pharma Showcases Its Latest Endocrinology Programs, Data, and Research at ENDO 2023

Retrieved on: 
Tuesday, June 13, 2023
ENDO, Multicenter trial, Turner syndrome, Hypoparathyroidism, Pathway, Efficacy, Saint Andrew's Society, Research, Human Accomplishment, Southern Transcon, Randomness, Endocrine Society, Poster, Pharmaceutical industry, Achondroplasia, Tolerability, Safety, Endocrinology

COPENHAGEN, Denmark, June 13, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will showcase its latest Endocrinology Rare Disease programs, data, and research in growth hormone deficiency, hypoparathyroidism, achondroplasia, and Turner Syndrome at ENDO 2023, the annual meeting of the Endocrine Society being held June 15-18 in Chicago.

Key Points: 
  • - Endocrinology clinical development progress and research in growth hormone deficiency, hypoparathyroidism, achondroplasia, and Turner Syndrome will be highlighted
    COPENHAGEN, Denmark, June 13, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will showcase its latest Endocrinology Rare Disease programs, data, and research in growth hormone deficiency, hypoparathyroidism, achondroplasia, and Turner Syndrome at ENDO 2023, the annual meeting of the Endocrine Society being held June 15-18 in Chicago.
  • An oral presentation on Saturday, June 17, will feature Phase 3 Week 52 data for TransCon PTH in adults with hypoparathyroidism, and five additional poster presentations listed in the table below will showcase other Ascendis programs and data.
  • In addition, Ascendis will host booth #1628, booth #1740, and two product theaters during ENDO 2023.
  • Long-Term Efficacy and Safety of TransCon PTH in Adults with Hypoparathyroidism: 52-Week Results from the Open-Label Extension of the PaTHway Phase 3 Trial
    Clinical and Economic Burden of Postsurgical Chronic Hypoparathyroidism: A U.S. Medicare Retrospective Analysis
    Significantly Improved Annual Height Velocity with Once-Weekly TransCon CNP in Children with Achondroplasia: The ACcomplisH Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Trial
    Design of the New InsiGHTS Trial: A Multicenter, Phase 2, Randomized, Open-Label, Active Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Lonapegsomatropin in Prepubertal Individuals with Turner Syndrome

Teva Presents Real-World Data for AUSTEDO® (deutetrabenazine) Tablets with 4-Week Patient Titration Kit at Psych Congress Elevate 2023

Retrieved on: 
Friday, June 2, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Psych, Teva Pharmaceuticals, Interim, Risk, VMAT2, TEVA, Global R&D management, START, Teva, Use, TD, De novo, State University of New York Upstate Medical University, Safety, Efficacy, Clinical Global Impression, Doctor of Philosophy, Patient, Medication, PGIC, Tablet, Congress, DE, User experience, MD, Poster, Randomness, TASE, Olanzapine, Annual general meeting, Chorea, Treatment, AM, Effectiveness, Reactions on surfaces, XR, FDA, Mental health, Tardive dyskinesia, NYSE, SHINE, Pharmaceutical industry, Nursing, Tolerability, Schizophrenia

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 12 presentations across its neuroscience portfolio featured at the Psych Congress Elevate 2023 Annual Meeting taking place on June 1-4, 2023.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 12 presentations across its neuroscience portfolio featured at the Psych Congress Elevate 2023 Annual Meeting taking place on June 1-4, 2023.
  • Two presentations feature real-world data for AUSTEDO (deutetrabenazine) tablets for adults living with TD.
  • Data presented will include interim findings from the START trial, a Phase 4 study investigating real-world utilization of AUSTEDO with a 4-week patient titration kit along with treatment success as measured at the end of treatment.
  • Teva will also present findings from studies evaluating potential drug-drug interactions with VMAT2 inhibitors, as well as patient and healthcare provider perspectives on the impact of TD.

SciSparc Announces Successful Final Phase IIa Results, Meeting End Points of its Phase IIa Alzheimer Disease Patients with Agitation Trial

Retrieved on: 
Friday, June 2, 2023
Edinburgh, CMAI, Central nervous system, Delirium, Alzheimer's disease, Benzodiazepine, Hypotension, Disease, Tolerability, Eating, Quality of life, IMCA, Falls, Appetite, Doctor of Philosophy, Agitation, Dementia, MD, Mini–Mental State Examination, SD, AD, SCI, Edinburgh Feeding Evaluation in Dementia Scale, Sophie, Pharmaceutical industry, Medical imaging, Safety, Patient

Agitation manifests over the course of AD’s progression in almost all affected patients, increasing patients’ suffering and burden of care.

Key Points: 
  • Agitation manifests over the course of AD’s progression in almost all affected patients, increasing patients’ suffering and burden of care.
  • This Phase IIa clinical trial was an open label  trial, which included 18 patients diagnosed with AD and agitation, to evaluate the safety, tolerability, and efficacy trends of twice daily oral administration of SCI-110.
  • In general, the trial medication was well tolerated with no negative response to the treatment observed throughout the trial duration.
  • Alzheimer disease' patients experience many different symptoms that deteriorate their condition including lack of appetite, sleep quality and agitation.

BioXcel Therapeutics Announces Promising Topline Results from Part 1 of Pivotal SERENITY III Trial of BXCL501 for At-Home Use in Acute Treatment of Agitation in Bipolar Disorders or Schizophrenia

Retrieved on: 
Thursday, May 25, 2023
Yale School of Medicine, Bradycardia, Orthostatic hypotension, Dexmedetomidine, Somnolence, Schizophrenia, Xerostomia, Hypotension, Safety, Tolerability, Yale school, BS 5839 Part 1, II, Șaeș, Alignment, Incidence, PEC, Dizziness, Patient, Translational research, Psychiatry, Artificial intelligence, FDA, Therapy, Agitation, Bipolar disorder, Caregiver, DSM-IV codes, Vaccine, Pharmaceutical industry, Part

BXCL501 would represent the first-ever FDA approved therapy for at-home use in this indication, if approved.

Key Points: 
  • BXCL501 would represent the first-ever FDA approved therapy for at-home use in this indication, if approved.
  • SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 in acutely agitated adult patients with bipolar disorders or schizophrenia for at-home use.
  • Although the primary efficacy endpoint was not statistically significant at 2 hours (p=0.077), BXCL501 separated from placebo at 4 hours (p=0.049).
  • These data provide a clear path for initiating SERENITY III Part 2, to pursue approval in the at-home setting.

Ceapro Inc. Reports Financial Results for First Quarter 2023 and Provides Corporate Update

Retrieved on: 
Thursday, May 25, 2023
GMP, Avenanthramide, Senior, Administration, Safety, Symrise, TSX Venture Exchange, Clinical trial, EPCM, G&A, MBA, Coenzyme Q10, Regulation and licensure in engineering, Trial of the century, YBG, Special Operations Executive, Regeneration, Ethics, Mask, The Angiogenesis Foundation, McMaster University, Organic acid, Pharmacokinetics, Investment, ALG, Mouse, Hand, Montreal Heart Institute, CZO, Skin, Technical, Wound healing, Pharmaceutical industry, Tolerability

EDMONTON, Alberta, May 25, 2023 (GLOBE NEWSWIRE) -- Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced financial results and operational highlights for the first quarter ended March 31, 2023.

Key Points: 
  • “Our team significantly advanced toward several key milestones related to new product development as well as strategic corporate initiatives.
  • Up to 96 subjects may be included in the study and dosages will escalate from 30 mg to 960 mg according to response.
  • Announced positive results from animal studies conducted by Angiogenesis Foundation on a wound healing model.
  • Financial Highlights for the First Quarter Ended March 31, 2023
    Total sales of $3,500,000 for the first quarter of 2023 compared to $6,172,000 for the comparative period in 2022.

Alpine Immune Sciences to Present Data from RUBY-1, a Phase 1 Study of Povetacicept, at Upcoming Scientific Congresses

Retrieved on: 
Friday, May 19, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Volunteering, European Hematology Association, APS, Lupus, SLE, European Congress of Radiology, Festhalle, Autoimmunity, Toronto Congress Centre, ALPN, EHA, EULAR, Treatment, Inflammation, Pharmaceutical industry, Vaccine, Tolerability, Safety, Pharmacokinetics

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company will present data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers, at multiple upcoming scientific congresses, including participation in a poster tour at the European Congress of Rheumatology (EULAR) and an oral presentation at the European Hematology Association (EHA).

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company will present data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers, at multiple upcoming scientific congresses, including participation in a poster tour at the European Congress of Rheumatology (EULAR) and an oral presentation at the European Hematology Association (EHA).
  • Presentation Title: A Placebo-Controlled Phase 1 Study in Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Povetacicept, a Potent Dual BAFF/APRIL Antagonist, for the Treatment of Systemic Lupus Erythematosus
    Session Name: Short Oral Presentation Session 16, SLE Treatment 2
    Poster Title: A Placebo-Controlled Phase 1 Study in Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Povetacicept (ALPN-303), a Potent Dual BAFF/APRIL Antagonist, for the Treatment of Systemic Lupus Erythematosus and Other B Cell-Related Disorders (RUBY-1)
    Session Name: A novel journey into SLE, Sjögren's and APS
    Poster Title: Povetacicept (ALPN-303), A Potent Dual BAFF/APRIL Antagonist, for the Treatment of Autoimmune Cytopenias and Other Antibody-Related Diseases
    Location: Panorama 2, Congress Centre, Forum, Festhalle and Halls 1 and 3 of Messe Frankfurt, Frankfurt, Germany
    Presentation Title: Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Povetacicept for Autoimmune Glomerulonephritides