Treatment

EQS-News: Immunic Presents Data From Phase 2 CALLIPER and CALVID-1 Trials of Vidofludimus Calcium at the ACTRIMS Forum 2024

Retrieved on: 
Wednesday, March 13, 2024

“Having two poster presentations on our lead asset, vidofludimus calcium, at the prestigious ACTRIMS Forum is a testament to the strength of the data we have generated,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.

Key Points: 
  • “Having two poster presentations on our lead asset, vidofludimus calcium, at the prestigious ACTRIMS Forum is a testament to the strength of the data we have generated,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.
  • We believe that the data set provides biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential.
  • Recent third-party data in post COVID patients identified EBV reactivation as a potential cause for fatigue in this patient group.
  • Fox, MD, Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio

Lexeo Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Monday, March 11, 2024

NEW YORK, March 11, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today reported fourth quarter and full year 2023 financial results and provided operational highlights.

Key Points: 
  • Data to date suggest that FA patients may have lower FXN levels in the heart versus peripheral tissues.
  • Across all three cardiac biopsies, we observed an increase in FXN levels as measured by liquid chromatography mass spectrometry relative to pre-treatment baseline levels.
  • Lexeo anticipates the gross proceeds from the private placement to be approximately $95.0 million, before deducting any offering related expenses.
  • G&A expenses were $15.4 million for the year ended December 31, 2023, compared to $12.0 million for the same period in 2022.

Ventyx Biosciences Reports Clinical Data for its NLRP3 Inhibitor Portfolio and Provides Pipeline Updates at Virtual Investor Event

Retrieved on: 
Monday, March 11, 2024

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, will provide clinical and pipeline updates today during its virtual investor event.

Key Points: 
  • We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases.
  • We believe these data establish compelling clinical proof of concept for our peripheral NLRP3 inhibitor VTX2735.
  • At our virtual investor event, we will present data from the ongoing Phase 2 open-label extension.
  • Ventyx will host a virtual investor event today, Monday, March 11, 2024 from 11:00AM to 12:30PM ET.

Nitrase Therapeutics Unveils Pioneering Antibody Candidate for Parkinson’s Disease Based on Nitration Discovery in Oral Presentation at the Alzheimer’s Disease and Parkinson’s Disease (AD/PD) Conference

Retrieved on: 
Monday, March 11, 2024

BRISBANE, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Nitrase Therapeutics, Inc., a biopharmaceutical company deploying its NITROME platform to build a pipeline of therapies targeting nitrases and their substrates, a new class of enzymes discovered in-house that are implicated in a broad variety of diseases, today announced an abstract titled “Unveiling of a Novel Therapeutic Antibody Targeting Nitrated Alpha Synuclein for the Treatment of Parkinson’s Disease” was featured in an oral presentation at the Alzheimer’s Disease and Parkinson’s Disease (AD/PD) Conference taking place in Lisbon, Portugal from March 5-9, 2024. The presentation outlined data with Nitrase’s first-in-class antibody targeting extracellular nitrated alpha-synuclein (α-synuclein) for the treatment of Parkinson’s disease (PD) and other synucleinopathies. Nitrase’s antibody demonstrated both high affinity and selectivity for nitrated synuclein, and it demonstrated the ability to significantly reduce PD progression in in vitro and in vivo PD models.

Key Points: 
  • The presentation outlined data with Nitrase’s first-in-class antibody targeting extracellular nitrated alpha-synuclein (α-synuclein) for the treatment of Parkinson’s disease (PD) and other synucleinopathies.
  • A hallmark of PD pathology is the presence of Lewy Bodies and Lewy Neurites, which have been found to include an accumulation of nitrated α-synuclein.
  • It has been established in published studies that PD pathology spreads between brain regions along neural circuitry through extracellular aggregated α-synuclein.
  • Additionally, our antibody demonstrated superiority in a preclinical efficacy evaluation against the parental antibody of  prasinezumab, which targets non-nitrated α-synuclein.

Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US

Retrieved on: 
Thursday, March 7, 2024

MELBOURNE, Australia, March 07, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim topline results confirming that a single daily dose of Travelan® is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC).

Key Points: 
  • This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study.
  • Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024.
  • To learn more about Phase 2 study design, read: U.S. Food and Drug Administration Step 3: Clinical Research
    IMM-124E (Travelan®) will be the first product developed with Immuron’s platform technology to proceed into Phase 3 clinical trials.
  • Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials.

Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results

Retrieved on: 
Wednesday, March 6, 2024

The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.
  • Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval.
  • The Company expects a decision by the EMA in the fourth quarter of 2024.
  • Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.

Biomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219’s 28-Day Treatment Cycle, Supporting Improved Pancreatic Function

Retrieved on: 
Wednesday, March 6, 2024

REDWOOD CITY, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced three poster presentations presenting long-term 26 week follow-up data from patients treated with BMF-219, enrolled in the escalation portion of the ongoing Phase II clinical study (COVALENT-111), at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place in Florence, Italy from March 6-9, 2024. This clinical data from all dosing cohorts initiated to date as of February 12, 2024 from the Escalation Phase of COVALENT-111 will be featured during a Poster Discussion Presentation and two Poster Viewing Presentations at ATTD. Biomea will showcase the following three e-poster presentations:

Key Points: 
  • Please find a link here to our website where the poster presentations and discussion will be available.
  • A higher proportion of patients treated with 200mg QD achieved a clinically significant reduction in HbA1c compared to 100mg QD dosing.
  • A durable glycemic response (≥1.0% HbA1C reduction) was seen in 20% and 36% of patients in once daily 100 mg and 200 mg cohorts, respectively.
  • A PK study further assessing the optimal use of BMF-219 to ensure minimal variability of exposure is currently under way.

Pharvaris to Present Deucrictibant Clinical Data at Upcoming Congresses

Retrieved on: 
Wednesday, March 6, 2024

ZUG, Switzerland, March 06, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the acceptance of abstracts for presentation at two upcoming congresses: the 3rd National Congress of the Italian Network for Hereditary and Acquired Angioedema (ITACA) , to be held from March 14-16, 2024, in Milan, Italy, and the 2024 HAE International (HAEi) Regional Conference Americas , to be held from March 15-17, 2024, in Panama City, Panama.

Key Points: 
  • ZUG, Switzerland, March 06, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the acceptance of abstracts for presentation at two upcoming congresses: the 3rd National Congress of the Italian Network for Hereditary and Acquired Angioedema (ITACA) , to be held from March 14-16, 2024, in Milan, Italy, and the 2024 HAE International (HAEi) Regional Conference Americas , to be held from March 15-17, 2024, in Panama City, Panama.
  • Details of the presentations are as follows:
    Title: Design of RAPIDe-3 Phase 3 Trial: Efficacy and Safety of the Oral Bradykinin B2 Receptor Antagonist Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks
    Title: Efficacy and Safety of Bradykinin B2 Receptor Antagonism with Deucrictibant Immediate-Release Capsule for Treatment of Hereditary Angioedema Attacks: Results of RAPIDe-1 Phase 2 Trial
    Title: Efficacy and Safety of Oral Deucrictibant, a Bradykinin B2 Receptor Antagonist, in Prophylaxis of Hereditary Angioedema Attacks: Results of CHAPTER-1 Phase 2 Trial
    2024 HAEi Regional Conference Americas, Panama City, Panama, March 15-17, 2024.
  • Title: Efficacy and Safety of the Oral Bradykinin B2 Receptor Antagonist Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks: RAPIDe-3 Phase 3 Trial Design
    Title: Efficacy and Safety of Bradykinin B2 Receptor Antagonism with Deucrictibant Immediate-Release Capsule for Treatment of Hereditary Angioedema Attacks: Results of RAPIDe-1 Phase 2 Trial
    Title: Efficacy and Safety of Oral Deucrictibant, a Potent Bradykinin B2 Receptor Antagonist, in Prophylaxis of Hereditary Angioedema Attacks: Results of CHAPTER-1 Phase 2 Trial
    Title: Understanding Patient Reasons not to Treat All Hereditary Angioedema (HAE) Attacks and Characteristics of Untreated HAE Attacks: Results from a Real World Survey
    The posters and presentation slides will be made available on the Investors section of the Pharvaris website at the beginning of the respective presentations at: https://ir.pharvaris.com/news-events/events-presentations .

embecta-sponsored Educational Symposium and Abstracts at ATTD Highlight Role of Insulin Pumps in the Management of Type 2 Diabetes

Retrieved on: 
Wednesday, March 6, 2024

Additionally, six embecta-sponsored abstracts focusing on injection and insulin pump therapies have been selected for presentation as scientific posters at ATTD 2024.

Key Points: 
  • Additionally, six embecta-sponsored abstracts focusing on injection and insulin pump therapies have been selected for presentation as scientific posters at ATTD 2024.
  • Entitled “Unlocking the potential of insulin pumps for personalized T2D care,” the symposium aims to highlight the significance of insulin pump therapy among the extensive treatment options available for type 2 diabetes (T2D).
  • The six embecta-sponsored abstracts set for presentation as scientific posters, include robust data about insulin therapy via both pumps and multiple daily injections (MDI).
  • Another poster highlights data showing that in individuals with type 2 diabetes, insulin pump therapy eases constraints imposed by diabetes management and improves quality of life.

Gain Therapeutics Presents Data at the AD/PD™ 2024 Conference Demonstrating the Mechanism of Action of GT-02287, its Clinical Stage GCase Regulator for the Treatment of Parkinson’s Disease

Retrieved on: 
Tuesday, March 5, 2024

AD/PD™ 2024 is being held March 5th – 9th, 2024 in Lisbon, Portugal.

Key Points: 
  • AD/PD™ 2024 is being held March 5th – 9th, 2024 in Lisbon, Portugal.
  • GCase is consequently able to travel to the lysosome, resulting in enhanced lysosomal activity and efficient processing of the GCase substrate glucosylceramide.
  • Increase in GCase substrate in the lysosome was previously shown to be associated with accumulation of aggregated alpha-synuclein, a pathological hallmark of Parkinson’s disease and related disorders.
  • “These data further confirm our understanding of the mechanism of action of GT-02287, how it impacts cellular health by preventing the downstream consequences of GCase misfolding, including cellular stress and lysosomal dysfunction” commented Dr. Natalia Perez-Carmona, Senior Director of Biology at Gain Therapeutics and presenting author.