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EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Developments

Retrieved on: 
Thursday, March 7, 2024

ET –

Key Points: 
  • ET –
    WATERTOWN, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the fourth quarter and year ended December 31, 2023, and highlighted recent corporate developments.
  • “2023 was an exceptional year of execution and results for EyePoint Pharmaceuticals.
  • Review of Results for the Fourth Quarter Ended December 31, 2023
    For the quarter ended December 31, 2023, total net revenue was $14.0 million compared to $10.5 million for the quarter ended December 31, 2022.
  • ET to discuss the results for the fourth quarter and year ended December 31, 2023 and recent corporate developments.

NodThera’s NLRP3 Inhibitor NT-0796 Reverses Neuroinflammation in Parkinson’s Disease Phase Ib/IIa Trial

Retrieved on: 
Thursday, March 7, 2024

IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.

Key Points: 
  • IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.
  • In addition, reductions in neurodegenerative markers were also observed following oral dosing of NT-0796, including NfL and soluble TREM (sTREM2).
  • The correlation between Parkinson’s disease and neuroinflammation is well-documented, with alpha-synuclein fibrils triggering microglial NLRP3 activation, leading to neuroinflammation and subsequent neurodegeneration.
  • This is the inaugural demonstration of an NLRP3 inhibitor’s potential to not only address Parkinson’s disease but also offer a broader impact on neurodegenerative diseases.

4DMT Reports Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Thursday, February 29, 2024

We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2027.

Key Points: 
  • We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2027.
  • R&D Expenses: Research and development expenses were $97.1 million for 2023, as compared to $80.3 million for 2022.
  • G&A Expenses: General and administrative expenses were $36.5 million for 2023, as compared to $32.9 million for 2022.
  • Net Loss: Net loss was $100.8 million for 2023, as compared to net loss of $107.5 million for 2022.

BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Tuesday, February 27, 2024

Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.

Key Points: 
  • Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study.
  • The planned primary outcomes are all-cause mortality at Day 28 between treatment groups and incidence, causality, and severity of SAEs in rhu-pGSN vs placebo treatment.
  • Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.
  • In the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions.

Janux Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Friday, March 8, 2024

“2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.

Key Points: 
  • “2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic.
  • RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
    Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in February 2024.
  • Janux plans to deploy these funds to expand development of clinical programs, advance additional preclinical programs and extend corporate runway.
  • FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:
    Cash and cash equivalents and short-term investments: As of December 31, 2023, Janux reported cash and cash equivalents and short-term investments of $344.0 million compared to $327.0 million at December 31, 2022.

LimmaTech Biologics Reports Positive Interim Phase I/II Clinical Data on Tetravalent Shigella Bioconjugate Vaccine S4V

Retrieved on: 
Thursday, February 22, 2024

LimmaTech Biologics AG announced positive interim data from its Phase I/II clinical trial evaluating Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis, an infectious disease caused by Shigella bacteria.

Key Points: 
  • LimmaTech Biologics AG announced positive interim data from its Phase I/II clinical trial evaluating Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis, an infectious disease caused by Shigella bacteria.
  • Topline data from the now completed Phase I/II trial, conducted in Kenya, are expected in the first half of 2024.
  • LimmaTech’s S4V vaccine candidate demonstrated initial safety in all age groups evaluated already in the first part of the clinical trial.
  • “These positive interim results with S4V establish the very good immunogenicity that our bioconjugate vaccine candidate can generate in nine-month-old infants, a population that needs it the most,” commented Patricia Martin, PhD, Chief Operating Officer of LimmaTech.

KalVista Pharmaceuticals Reports Phase 3 KONFIDENT Trial Meets All Endpoints for Sebetralstat as First Oral On-demand Therapy for Hereditary Angioedema

Retrieved on: 
Tuesday, February 13, 2024

The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile.

Key Points: 
  • The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile.
  • Treatment-related adverse event rates were 2.3% for 300 mg sebetralstat, 2.2% for 600 mg sebetralstat, and 4.8% for placebo.
  • “We are thrilled to announce positive phase 3 results for the KONFIDENT trial, which we believe position sebetralstat to become the first oral, on-demand therapy for the treatment of HAE.
  • Hereditary Angioedema Association Center at the University of California, San Diego, and an investigator for the KONFIDENT phase 3 trial.

Orchard Therapeutics Announces First Patient Randomized in Registrational Trial of OTL-203 for MPS-I Hurler Syndrome

Retrieved on: 
Monday, February 5, 2024

TOKYO, LONDON and BOSTON, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the first patient has been randomized at the M Health Fairview Masonic Children’s Hospital in a registrational trial evaluating the efficacy and safety of OTL-203, an investigational hematopoietic stem cell (HSC) gene therapy, in patients with the Hurler subtype of mucopolysaccharidosis type I (MPS-IH). The trial, referred to as HURCULES, compares treatment with OTL-203 to standard of care with allogeneic hematopoietic stem cell transplant (HSCT), and is expected to enroll 40 MPS-IH patients at sites across the U.S. and Europe.

Key Points: 
  • Approximately 60 percent of children born with MPS-I have the most severe subtype, MPS-IH, also called Hurler syndrome, and rarely live past the age of 10 when untreated.
  • Current treatment options for MPS-IH include allogeneic hematopoietic stem cell transplant (HSCT) and enzyme replacement therapy (ERT), both of which have significant limitations.
  • One patient experienced an acute hypersensitivity reaction that was considered probably related to HSC gene therapy.
  • The viral vector integration profile was comparable with other Orchard Therapeutics lentiviral-based HSC gene therapy studies, and all participants had a stable and highly polyclonal repertoire.

EyePoint Pharmaceuticals Announces Two Presentations of Topline Data with Additional Subgroup Analyses from the Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for the Treatment of Wet Age-Related Macular Degeneration

Retrieved on: 
Saturday, February 3, 2024

This result confirms that the positive visual and anatomical outcomes from our Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections.

Key Points: 
  • This result confirms that the positive visual and anatomical outcomes from our Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections.
  • A second presentation also included the previously reported positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901.
  • DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD.
  • Phase 2 DAVIO 2 12-month results and the initiation of a Phase 3 trial in wet AMD are both expected in the second half of 2024.

NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

Retrieved on: 
Thursday, February 1, 2024

CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year.

Key Points: 
  • The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year.
  • "Clearance of the IND for DA-1726 allows us to proceed with the Phase 1 program for this novel GLP-1 and glucagon dual receptor, a potential new treatment to address the significant obesity market," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo.
  • Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726.
  • Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.