Dyslipidemia

VIVUS Announces it will Provide Telehealth to Patients through an Enhanced 'Engage' Program in Collaboration with UpScriptHealth

Retrieved on: 
월요일, 4월 22, 2024

CAMPBELL, Calif., April 22, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced it has entered into a strategic partnership with UpScriptHealth, a leading, nationwide, direct-to-consumer telemedicine company. The program, titled “VIVUS Engage,” will establish a robust online telemedicine platform for the distribution of QSYMIA® (phentermine and topiramate extended-release capsules CIV), the leading non-injectable branded weight loss medication in the U.S. for adults.

Key Points: 
  • Under the terms of the agreement, UpScript LLC will make QSYMIA available to patients through its proprietary Telehealth Platform.
  • With over 20 years of experience and more than one million patients served, UpScriptHealth specializes in creating effective web-based campaigns for pharmaceutical companies.
  • For patients actively seeking online support and solutions, UpScriptHealth offers a fast and convenient option.
  • Combined with a healthy diet and exercise, it has been proven to help patients lose weight and maintain weight loss.

Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity

Retrieved on: 
목요일, 4월 11, 2024

Furthermore LPCN 2401 could help to attenuate collateral fattening and rebound fat/weight "overshoot" associated with discontinuation of GLP-1/GIP agonists.

Key Points: 
  • Furthermore LPCN 2401 could help to attenuate collateral fattening and rebound fat/weight "overshoot" associated with discontinuation of GLP-1/GIP agonists.
  • We look forward to meeting with the FDA to discuss the further development of LPCN 2401 as an aid to weight management interventions."
  • Analyses of body composition parameters, including prespecified endpoints of whole body LM and whole-body FM, are reported in the table below.
  • An overall improvement in body composition is evidenced by substantial decrease in the fat mass to lean mass ratio.

MediciNova Announces Two Abstracts regarding MN-001 (tipelukast) and MN-002 Accepted for Presentation at the 92nd EAS 2024 Congress, the Annual Meeting of the European Atherosclerosis Society

Retrieved on: 
수요일, 3월 20, 2024

Presentation details will be disseminated as they become available.

Key Points: 
  • Presentation details will be disseminated as they become available.
  • Ph.D., M.P.H., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased that the two presentations were accepted at the EAS 2024 Congress.
  • One presentation is regarding the objectives and design of the ongoing Phase 2 clinical trial enrolling patients with Type 2 diabetes, dyslipidemia, and NAFLD.
  • The other presentation is regarding the mechanism of action of MN-001/MN-002 in lipid metabolism, particularly the effects on cholesterol efflux capacity.

NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD

Retrieved on: 
화요일, 3월 12, 2024

NAARDEN, The Netherlands and MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.

Key Points: 
  • The ACC Expert Consensus set LDL-C goals of below the 70mg/dl for patients with ASCVD and below the 55mg/dl goal for ASCVD patients with very high risk.
  • The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo.
  • NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl.
  • Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.

Ketogenic Diet Shows Promise in Treating Serious Mental Illness in Stanford Medicine Study

Retrieved on: 
월요일, 4월 1, 2024

SAN MATEO, Calif., April 1, 2024 /PRNewswire/ -- The field of psychiatry may have a new ally in the form of a medical ketogenic diet, according to the findings of a pioneering pilot study published in Psychiatry Research and announced today by Stanford Medicine. The study, supported by funding from Baszucki Group and others, is the first U.S.-based clinical trial to examine the therapeutic impact of a ketogenic dietary intervention for serious mental illness since 1965. 

Key Points: 
  • The study, supported by funding from Baszucki Group and others, is the first U.S.-based clinical trial to examine the therapeutic impact of a ketogenic dietary intervention for serious mental illness since 1965.
  • The results offer compelling evidence of the potential benefits of ketogenic dietary therapy in this population.
  • Key findings of the single-arm pilot trial include:
    100% of participants who met the criteria for metabolic syndrome were in remission by the end of the study.
  • Dr. Sethi shared: "These results are encouraging and suggest that a ketogenic diet intervention could serve as a valuable adjunctive treatment for individuals living with serious mental illness.

ZyVersa Therapeutics Highlights Data from Review Article Published in Nature Reinforcing IC 100’s Rationale for Inhibiting ASC and ASC Specks to Attenuate Damaging Inflammation Associated with Various Conditions, Including Obesity and Its Complications

Retrieved on: 
수요일, 2월 28, 2024

Pyroptosis results in systemic release of inflammatory cytokines, IL-1β and IL-18, and ASC specks, which perpetuates and spreads inflammation to other tissues leading to the metabolic disturbances associated with obesity.

Key Points: 
  • Pyroptosis results in systemic release of inflammatory cytokines, IL-1β and IL-18, and ASC specks, which perpetuates and spreads inflammation to other tissues leading to the metabolic disturbances associated with obesity.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation.
  • WESTON, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, highlights data published in Nature reinforcing IC 100’s rationale for inhibiting ASC and ASC Specks to attenuate damaging inflammation associated with various conditions, including obesity and its complications.
  • Likewise, IC 100 uniquely inhibits ASC specks to attenuate spread and perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here .

Sirius Therapeutics Begins Phase 1 Clinical Trial of Next-Generation, Long-Acting Factor XI siRNA Anticoagulant for Treatment of Thromboembolic Disorders

Retrieved on: 
금요일, 2월 2, 2024

Sirius Therapeutics, announced it has dosed the first subject in a Phase 1, first-in-human clinical trial in Australia of SRSD107 on January 30th 2024, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders.

Key Points: 
  • Sirius Therapeutics, announced it has dosed the first subject in a Phase 1, first-in-human clinical trial in Australia of SRSD107 on January 30th 2024, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders.
  • SRSD107 is the second clinical candidate in the company’s portfolio of next generation siRNA therapeutics to treat cardiovascular diseases.
  • The company recently began clinical trials of SRSD101 in China for the treatment of dyslipidemia following IND clearance from the China National Medical Products Administration.
  • “This trial is based on in vivo studies that demonstrated a nearly 100% reduction of FXI levels for up to 6 months, without bleeding events, after a single subcutaneous dose,” said Dr. Qunsheng Ji, Sirius Therapeutics’ Chief Executive Officer.

Recce Pharmaceuticals Reports Positive Phase I/II Trial Results of RECCE® 327 for the Treatment of Diabetic Foot Infections

Retrieved on: 
화요일, 1월 23, 2024

The patient was on systemic therapy and was required to stop treatment to meet the trial protocol of R327, requiring solely topical application.

Key Points: 
  • The patient was on systemic therapy and was required to stop treatment to meet the trial protocol of R327, requiring solely topical application.
  • On day 15 (midpoint), post-R327 treatment, the initial redness of the wound and swelling of the foot had minimized and reduced in size.
  • Due to patient comorbidities and the complexity of the wound, the patient was returned to systemic therapy, resulting in disqualification from the trial.
  • After three doses of R327 treatment (midpoint – day 7), the infection was significantly reduced, with the wound drying and rapidly improving.

Non-Alcoholic Steatohepatitis Treatment Drug Market In Japan is Expected to Showcase Impressive Growth by 2032 | DelveInsight

Retrieved on: 
수요일, 1월 17, 2024

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.

Key Points: 
  • LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.
  • According to DelveInsight's analysis, the market size for NASH reached USD 200 million in 2022 in Japan and is expected to grow with a significant CAGR by 2032.
  • DelveInsight's analysis reveals that the overall diagnosed prevalent population of NASH in Japan was reported as 2.5 million in 2022.
  • Among the forecasted emerging therapies, MGL-3196 (Resmetirom) is expected to capture the highest market in Japan by 2032.

Non-Alcoholic Steatohepatitis Treatment Drug Market In Japan is Expected to Showcase Impressive Growth by 2032 | DelveInsight

Retrieved on: 
수요일, 1월 17, 2024

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.

Key Points: 
  • LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Non-Alcoholic Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, non-alcoholic steatohepatitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into Japan.
  • According to DelveInsight's analysis, the market size for NASH reached USD 200 million in 2022 in Japan and is expected to grow with a significant CAGR by 2032.
  • DelveInsight's analysis reveals that the overall diagnosed prevalent population of NASH in Japan was reported as 2.5 million in 2022.
  • Among the forecasted emerging therapies, MGL-3196 (Resmetirom) is expected to capture the highest market in Japan by 2032.