Tolerability

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

Cerevance Announces Oral Presentation of Phase 1 Data on CVN766 at American Society of Clinical Psychopharmacology (ASCP)

Retrieved on: 
Tuesday, May 16, 2023
Central nervous system, Therapy, Somnolence, CNS, ASCP, Patient, Randomness, Society, Pharmaceutical industry, Cerev Del, Tolerability, Safety

BOSTON, May 16, 2023 (GLOBE NEWSWIRE) -- Cerevance, a private, clinical-stage drug discovery and development company focused on developing novel therapeutics for central nervous system (CNS) diseases using the company’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) platform, today announced plans to present an oral presentation at the upcoming American Society of Clinical Psychopharmacology (ASCP) conference, taking place in Miami, Florida, May 30 – June 2, 2023.

Key Points: 
  • BOSTON, May 16, 2023 (GLOBE NEWSWIRE) -- Cerevance, a private, clinical-stage drug discovery and development company focused on developing novel therapeutics for central nervous system (CNS) diseases using the company’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) platform, today announced plans to present an oral presentation at the upcoming American Society of Clinical Psychopharmacology (ASCP) conference, taking place in Miami, Florida, May 30 – June 2, 2023.
  • “We are very excited to present the Phase 1 CVN766 data for the first time at a medical conference,” said Craig Thompson, chief executive officer of Cerevance.
  • “The favorable safety and tolerability profile coupled with lack of somnolence supports the potential of CVN766 to become an impactful treatment to address the unmet need of negative and cognitive symptoms in patients with schizophrenia.”
    Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766, an OX1R Highly Selective Antagonist in Healthy Subjects

BioXcel Therapeutics Announces Positive Top-Line Data from Repeat Dosing of BXCL501 in Phase 1b Multiple Ascending Dose Trial in Healthy Volunteers for Major Depressive Disorder (MDD) Program

Retrieved on: 
Tuesday, May 16, 2023
Volunteering, Index, Depression, Orthostatic hypotension, Dexmedetomidine, Half-life, Somnolence, Schizophrenia, Hypotension, Anxiety, Safety, Tolerability, Bipolar II disorder, Pharmacokinetics, DSM-IV codes, Disorder, Selective serotonin reuptake inhibitor, Dizziness, MDD, Patient, BID, Artificial intelligence, MTD, MAD, Intermittent explosive disorder, Serotonin–norepinephrine reuptake inhibitor, POC, Therapy, Headache, III, Agitation, Pharmaceutical industry, Vaccine, Neuroscience, HAVEN

NEW HAVEN, Conn., May 16, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced positive top-line data from its Phase 1b multiple ascending dose (MAD) trial of BXCL501 (dexmedetomidine) sublingual film. BXCL501 is the Company’s proprietary, orally dissolving film under investigation for the treatment of agitation associated with neuropsychiatric disorders and as a potential adjunctive treatment in Major Depressive Disorder (MDD).

Key Points: 
  • The trial was designed to evaluate the safety and tolerability of repeat dosing of BXCL501 in healthy volunteers as a single agent and in combination with antidepressant duloxetine.
  • “This positive outcome supports the potential market expansion opportunity for our lead asset, BXCL501, into chronic neuropsychiatric disorders,” said Vimal Mehta, CEO of BioXcel Therapeutics.
  • We believe these new data present a transformative opportunity beyond acute treatment for the BXCL501 program, including treatment for MDD.
  • The study’s primary objectives were to assess the safety, tolerability, and pharmacokinetics of BXCL501 in healthy volunteers in multiple ascending doses.