S1P

Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis

Retrieved on: 
Monday, April 1, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, EOS, Itolizumab, Week, S1P, Dialysis, Type, AMP, Exercise, Ono Pharmaceutical, Infection, Lymphocytopenia, Patient, Serum albumin, Peripheral edema, CD6, Lupus, EULAR, EGFR, Therapy, Proteinuria, ALC, Lupus nephritis, Nursing

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.

Key Points: 
  • Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.
  • Key topline data from the Type B portion of the EQUALISE study in lupus nephritis:
    Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g.
  • Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect.
  • Two subjects had at least one serious adverse event, none of which were related to study treatment.

Trevena Reports Third Quarter 2023 Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
CNS, Sale, Webcast, TMS, POC, Senior, University, Pain, Plasma, Rheumatology, Cleveland Clinic, Patient, Transcranial magnetic stimulation, Psychiatry, Trevena, ARTEMIS, NIH, Epilepsy, Abstract, EEG, S1P, ASA, Central nervous system, Chronic pain, Alertness, Neuropathic pain, Pharmaceutical industry, Medicine, Anesthesiology

ET

Key Points: 
  • ET
    CHESTERBROOK, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the third quarter ended September 30, 2023 and provided an overview of its recent operational highlights.
  • “There is a significant need for safe and effective non-opioid therapies in pain, and for novel mechanisms for the treatment of epilepsy.
  • The Company previously announced preliminary topline data from two Phase 1 proof-of-concept studies evaluating S1PR mechanism of action and CNS target engagement.
  • As part of the R-Bridge Financing, Trevena may receive an additional $10 million upon achievement of either a commercial or financing milestone.

US Gastroenterologist Projections Suggest Significant Shift in Ulcerative Colitis Landscape Afoot, with Launches of Eli Lilly's Omvoh, Pfizer's Velsipity, Takeda's Subcutaneous Entyvio, and Celltrion's Zymfentra

Retrieved on: 
Monday, November 13, 2023
HCP, Ustekinumab, Pfizer, Q3, JAK, Takeda, Patient, MOA, AbbVie, Colitis, Ulcerative colitis, Benchmarking, IBD, Launch, Upadacitinib, BMS, S1P, Infliximab, Adalimumab, Gastroenterology, Celltrion, UC, RealTime, Pharmaceutical industry, Tofacitinib, Vedolizumab, Lilly

These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.

Key Points: 
  • These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.
  • However, the influx of innovative agents suggests that upcoming changes are poised to be more substantial and transformative.
  • This extension enjoys the highest pre-launch familiarity and generates significantly higher interest in gaining approval.
  • Although prescribers display significant enthusiasm for Entyvio SC, its anticipated impact on the broader market is projected to be modest.

Equillium Presents Positive Data from Phase 1b EQUALISE Study at the 2023 Annual Meeting of the American College of Rheumatology

Retrieved on: 
Monday, November 13, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, EOS, Serum albumin, ALC, European Renal Association, MMF, Itolizumab, Safety, Ono Pharmaceutical, Dialysis, Type, Children's Organ Transplant Association, Patient, Bruce Steel, American College of Rheumatology, Novel, American College, Therapy, Lupus nephritis, Standard of care, ORR, Infection, Partnership, EGFR, CD6, S1P, EULAR, AMP, ACR, Trial of the century, Proteinuria, Pharmaceutical industry, Silviculture, Nursing, UPCR, Medicine, Lupus

“It’s important that we saw both early and large reductions in proteinuria,” said Dr.

Key Points: 
  • “It’s important that we saw both early and large reductions in proteinuria,” said Dr.
  • Results are comparable to those observed in the Phase 3 AURORA1 study of voclosporin (ORR 70% at 6 and 12 months in active treatment).
  • Consistent with the decline in UPCR overtime, subjects were able to taper their systemic corticosteroids over the course of the study.
  • The poster presentation is available on the Presentations page of Equillium’s website under the Lupus tab.

Equillium Announces Data from Phase 1b EQUALISE Study Presented at the 2023 Annual Meeting of the American Society of Nephrology

Retrieved on: 
Monday, November 6, 2023
Oncology, Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, EOS, Type, EULAR, Patient, Standard of care, Lupus nephritis, Itolizumab, III, EGFR, Therapy, AMP, Children's Organ Transplant Association, CD6, Infection, Society, American Society of Nephrology, European Alliance of Associations for Rheumatology, European Renal Association, Dialysis, ASN, Partnership, MMF, ORR, ALC, S1P, Ono Pharmaceutical, Safety, Serum albumin, Proteinuria, Pharmaceutical industry, Silviculture, Nursing, Lupus, UPCR

“The presentation at ASN represents current data from the EQUALISE study, which includes all but the last patient in the follow up period,” said Bruce Steel, chief executive officer at Equillium.

Key Points: 
  • “The presentation at ASN represents current data from the EQUALISE study, which includes all but the last patient in the follow up period,” said Bruce Steel, chief executive officer at Equillium.
  • “We are encouraged that we continue to see clinically meaningful response rates, particularly in these highly proteinuric subjects.
  • Results are comparable to those observed in the Phase 3 AURORA1 study of voclosporin (ORR 70% at 6 and 12 months in active treatment).
  • Consistent with the decline in UPCR overtime, subjects were able to taper their systemic corticosteroids over the course of the study.

Trevena Reports Favorable TRV045 Topline Safety and Tolerability Data from Proof-of-Concept Studies

Retrieved on: 
Monday, October 16, 2023
TMS, ECG, Plasma, Headache, Central nervous system, Safety, Epilepsy, Trevena, Heart rate, Somnolence, EEG, POC, Lymphocytopenia, Fatigue, Dizziness, Blood pressure, Bradycardia, Neuropathic pain, S1P, QT interval, CNS, Patient, Pharmaceutical industry, Sewage treatment

CHESTERBROOK, Pa., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported topline safety and tolerability data for the two Phase 1 proof-of-concept (POC) studies of TRV045, a novel sphingosine-1 phosphate receptor modulator selective for the S1P receptor subtype 1.   

Key Points: 
  • Each subject received three different single doses of TRV045 (50mg, 150mg and 300mg) and placebo on four separate visits across the study duration.
  • Subjects in both studies were enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application for TRV045.
  • This new safety and tolerability data in 50 subjects is generally consistent with, and further builds upon, the 89-subject data from the first-in-human study of TRV045 reported in November 2022.
  • “We are pleased to report additional safety and tolerability data which is consistent with what we have observed in prior datasets,” said Carrie Bourdow, President and CEO of Trevena.

Trevena Reports Second Quarter 2023 Results and Provides Business Update

Retrieved on: 
Monday, August 14, 2023
Epilepsy, Male, Cleveland Clinic, Central nervous system, Delirium, ARTEMIS, TMS, Atrium Health Wake Forest Baptist, EMR, Trevena, EMG, Campbell R. Bridges, PACU, CNS, Electronic health record, Pain, Patient, EEG, Cleveland, IND, S1P, Transcranial magnetic stimulation, Cryptocurrency, Pharmaceutical industry, Q3

We look forward to updating you as these developments occur.”

Key Points: 
  • We look forward to updating you as these developments occur.”
    Two TRV045 proof-of-concept studies near completion, exploring the potential for use in epilepsy and pain.
  • New respiratory data from ~200 patient VOLITION real-world outcomes study using continuous respiratory monitoring expected 3Q 2023.
  • For the second quarter of 2023, the Company reported net revenue of $3.0 million, and a net loss attributable to common stockholders of $8.0 million, or $0.69 per share, compared to $15.0 million, or $2.26 per share in the second quarter of 2022.
  • This cash balance does not include a $15 million non-dilutive tranche from the R-Bridge Financing that the Company anticipates receiving in the third quarter of 2023.

Trevena Reports First Quarter 2023 Results and Provides Business Update

Retrieved on: 
Monday, May 15, 2023
Epilepsy, Vomiting, Cleveland Clinic, Central nervous system, Senior, Delirium, ARTEMIS, Atrium Health Wake Forest Baptist, EMR, Trevena, PACU, CNS, Sale, Incidence, Patient, Central nervous system disease, National Medical Products Administration, Webcast, Transcranial magnetic stimulation, IND, Chronic pain, NMPA, Antiemetic, S1P, Pharmaceutical industry

OLINVYK receives Chinese regulatory approval; milestone and expected near-term commercialization provides up to $18 million of non-dilutive funding for Trevena.

Key Points: 
  • OLINVYK receives Chinese regulatory approval; milestone and expected near-term commercialization provides up to $18 million of non-dilutive funding for Trevena.
  • Jiangsu Nhwa Pharmaceutical (Nhwa) recently announced regulatory approval of OLINVYK from the National Medical Products Administration (NMPA) of China.
  • Recent Electronic Medical Records (EMR) data from the ARTEMIS study provides additional clinical support for the use of OLINVYK.
  • Cash, cash equivalents and marketable securities were $27.4 million as of March 31, 2023, which the Company believes will be sufficient to fund the Company’s operations through year-end 2023.

Trevena Reports Fourth Quarter 2022 Results and Provides Business Update

Retrieved on: 
Thursday, March 30, 2023
Epilepsy, Vomiting, Male, Cleveland Clinic, Central nervous system, Senior, Delirium, ARTEMIS, Atrium Health Wake Forest Baptist, EMR, Trevena, PACU, Confusion Assessment Method, CNS, Richmond Agitation-Sedation Scale, Sale, Incidence, Data analysis, Length of stay, Patient, Central nervous system disease, Risk, Nausea, Webcast, Transcranial magnetic stimulation, Hospital, Richmond, Abdominal ultrasonography, GI, S1P, Antiemetic, Peripheral nervous system, Nursing, Pharmaceutical industry, Cryptocurrency, Electroencephalography

CHESTERBROOK, Pa., March 30, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter ended December 31, 2022 and provided an overview of its recent operational highlights.

Key Points: 
  • As reference, in pooled data for the Company’s pivotal Phase 3 studies of OLINVYK, the GI complete response rate was 46.2% (0.35mg) and 39.7% (0.50mg).
  • Analysis of respiratory data from VOLITION is not yet available, and the Company expects to report these data mid-2023.
  • In the fourth quarter of 2022, the commercial team signed contracts with three new specialty distributors that focus primarily on ambulatory surgery centers (ASCs).
  • Cash and cash equivalents were $38.3 million as of December 31, 2022, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the fourth quarter of 2023.

Trevena Initiates Targeted Proof-of-Concept Study to Evaluate TRV045 as a Potential Treatment for Epilepsy and Other CNS Disorders

Retrieved on: 
Tuesday, March 7, 2023
Electroencephalography, IND, Electromyography, Volunteering, Trevena, EEG, Central nervous system, PK, CNS, Disease, Male, Transcranial magnetic stimulation, EMG, Patient, Central nervous system disease, Epilepsy, TMS, S1P, Pharmaceutical industry, Medical imaging

The study will use Transcranial Magnetic Stimulation (TMS) to evaluate how TRV045 affects the ability of brain cells to conduct electrical stimulation.

Key Points: 
  • The study will use Transcranial Magnetic Stimulation (TMS) to evaluate how TRV045 affects the ability of brain cells to conduct electrical stimulation.
  • The effects of TMS will be explored using both electromyography (EMG) and electroencephalography (EEG) to measure the potential effect of TRV045 on brain function.
  • “This is the second proof-of-concept study that we have initiated to explore TRV045 as a potential treatment of epilepsy and other CNS disorders,” said Carrie Bourdow, President and CEO of Trevena.
  • “These studies are designed to build upon non-clinical data, which indicate the potential anti-inflammatory signaling and disease modifying effect of TRV045.