Obesity

Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, April 1, 2024
Research, Glucose, Health, Congress, Obesity, Human, Drug discovery, Exercise, Glycated hemoglobin, DMR, ADAS, Partnership, Insulin, IDA, Patient, Weight loss, Michigan Medicine, Diabetes, Public expenditure, IDE, University, IPO, Tropism, Peptide, Transgene, Insulin resistance, Animal, NUB, Type 2 diabetes, Pancreas, Investigational New Drug, Therapy, Food, Marketing, FDA, Engineering, Annual general meeting, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today reported its fourth quarter and full year 2023 financial results and provided a business update.

Key Points: 
  • “In addition, we expect to complete enrollment of our pivotal Revitalize-1 study and are excited to report topline data in the fourth quarter of 2024.
  • The Company expects to complete enrollment in the first half of 2024 and report topline data in the fourth quarter of 2024.
  • In December 2023, Fractyl presented preclinical findings in an oral presentation at the World Congress of Insulin Resistance Diabetes and Cardiovascular Disease 2023 Annual Meeting.
  • Cash Position: As of December 31, 2023, Fractyl had approximately $33.2 million in cash and cash equivalents.

Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs

Retrieved on: 
Monday, April 1, 2024
Harvard Medical School, Investigational device exemption, Human, Obesity, Cardiovascular disease, Exercise, Risk, Patient, Food and Drug Administration, Weight loss, IDE, MD, Diet, Pharmacotherapy, Duodenum, Hospital, T2D, Wellness, Pathology, Therapy, BMI, FDA, Endoscopy, Food, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced U.S. Food and Drug Administration (FDA) approval of a pivotal Investigational Device Exemption (IDE) to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist (GLP-1RA) drug therapy, addressing a key unmet need in the treatment of obesity. Obesity affects over 40% of the US population and is a critical precursor to various highly morbid and expensive chronic conditions such as type 2 diabetes, metabolic dysfunction-associated fatty liver disease, and cardiovascular disease.

Key Points: 
  • The IDE approval launches the groundbreaking Remain-1 study, set to begin in the second half of 2024.
  • Remain-1 is a randomized, double-blind trial of Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy.
  • It is designed to be a pivotal study to potentially enable registrational filing for Revita for weight maintenance after GLP-1RA discontinuation.
  • The rationale for the Remain-1 pivotal study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy.

Avalon GloboCare Extends Exclusivity Agreement to Distribute KetoAir Breathalyzer Device and AI-Enabled Software in North America, South America, United Kingdom and European Union

Retrieved on: 
Thursday, March 28, 2024
Health, Obesity, Algorithm, Apple, Exercise, Qi, Diabetes, AI, Google Play, European, FDA, Medical device

KetoAir™ is a pioneering breathalyzer device equipped with AI-enabled software, designed for ketogenic health management (United States FDA registration number: 3026284320).

Key Points: 
  • KetoAir™ is a pioneering breathalyzer device equipped with AI-enabled software, designed for ketogenic health management (United States FDA registration number: 3026284320).
  • Moreover, the AI nutritionist within the app offers personalized nutritional and exercise recommendations tailored to each user's health goals.
  • “We are excited to extend our exclusive distribution agreement for KetoAir™ with Qi Diagnostics,” stated David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare.
  • “KetoAir™ is the first breathalyzer on the market that uses an AI nutritionist bundled with a nanosensor-based breathalyzer for ketogenic health management.

Omega Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Strategic Update

Retrieved on: 
Thursday, March 28, 2024
HCC, Research, Epigenomics, Toxicity, Obesity, Cell death, Growth, Burns, Gene expression, Novo Nordisk, NSCLC, AASLD, Appetite, OMEGA, DCR, Patient, Lung, Tissue, Cohort, CXCL9, CXCL10, Omega, G&A, Cancer, Messenger, Lung cancer, Human, Life expectancy, Liver regeneration, DLT, Fibrosis, Thermogenesis, Therapy, MYC, Liver, Pharmacokinetics, Hepatitis, CXCL11, LNP, Pharmaceutical industry

Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.

Key Points: 
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $6.2 million, compared to $5.7 million for the fourth quarter of 2022.
  • Net loss for the fourth quarter of 2023 was $20.2 million, compared to $30.8 million for the fourth quarter of 2022.
  • The decrease in net loss for 2023 compared to 2022 was primarily due to decreases in R&D expenses.

By 2035, Canada could have the most enviable healthcare system in the world if obesity is recognized as a chronic disease, predicts Obesity Canada

Retrieved on: 
Wednesday, March 27, 2024
Health, Conditional sentence, Cardiovascular disease, Conference, Obesity, Pressure, Notifiable disease, Hypertension, Diabetes, Accreditation, Research, Obesity Canada, Science, Death, Cancer, BMI, Pharmaceutical industry

The multiplication factor of obesity: Obesity is intricately linked with various chronic diseases, including cardiovascular diseases, diabetes, certain cancers, and joint problems, placing an immense burden on individual health and healthcare systems.

Key Points: 
  • The multiplication factor of obesity: Obesity is intricately linked with various chronic diseases, including cardiovascular diseases, diabetes, certain cancers, and joint problems, placing an immense burden on individual health and healthcare systems.
  • Obesity can be treated effectively; we know what to do: Canada is a global leader in obesity research and clinical expertise.
  • The Canadian Obesity Clinical Practice Guidelines are globally recognized as the gold standard and Canadian experts are highly regarded as thought leaders.
  • Revolutionizing our healthcare system: By officially recognizing obesity as a chronic disease and investing in evidence-based strategies, Canada (provincial and territorial health ministries) has the potential to lead the world in healthcare excellence within the next decade, predicts Obesity Canada.

Vaxxinity Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, March 27, 2024
Research, Neurodegenerative disease, Notifiable disease, LDL, Obesity, University, Comparison, PCSK9, Central Florida, Translational research, COVID-19, PD, CSF, Diabetes, Amprion, Patient, CNS, Mayo Clinic, Vaccine, Journal, Biomarker, Travel, Myostatin, Hope, SARS-CoV-2, D&O, Investment, Solid lipid nanoparticle, MDS, Marketing, Parkinson's disease, Hypercholesterolemia

CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX ), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
  • We also seek to advance UB-311, our anti-Aβ Alzheimer’s candidate, as we resume dialogue with regulatory authorities and partners.
  • General and administrative expenses were $3.4 million and $7.7 million for the three months ended December 31, 2023, and 2022, respectively.
  • General and administrative expenses were $22.4 million and $28.4 million for the years ended December 31, 2023, and 2022, respectively.

Clearmind Medicine Announces International Patent Application for Preventing and Treating Depression

Retrieved on: 
Wednesday, March 27, 2024
Patent Cooperation Treaty, Depression, Selective serotonin reuptake inhibitor, Obesity, CWY, Patent, Central nervous system, SSRI, Patient, DSM-IV codes, Mental health, Anxiety, Therapy, USD, Pharmaceutical industry

Vancouver, Canada, March 27, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY) (“Clearmind” or the “company”), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has submitted its tenth patent application under the international Patent Cooperation Treaty (“PCT”), as part of its ongoing collaboration with SciSparc Ltd. (Nasdaq: SPRC) (“SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system.

Key Points: 
  • The patent applications refer to the novel proprietary composition of Clearmind’s MEAI compound (5-methoxy-2-aminoindane) with Palmitoylethanolamide (“PEA”), the active ingredient of SciSparc’s proprietary CannAmide™, for preventing and/or treating depression.
  • This application was previously filed as provisional patent application with the United States Patent and Trademark Office (“USPTO”).
  • Under our collaboration with SciSparc, we believe that our proprietary drugs can positively impact patients dealing with various forms of depression including treatment resistant depression," stated Dr. Adi Zuloff-Shani, CEO of Clearmind.
  • "We further believe that we have a tremendous opportunity to develop viable alternatives to the current SSRIs for individuals living with depression.

SciSparc- Clearmind Collaboration Evolves with New International Patent Application for Preventing and Treating Depression

Retrieved on: 
Wednesday, March 27, 2024
Patent Cooperation Treaty, Depression, Obesity, CWY, Central nervous system, DSM-IV codes, Anxiety, Patent, Therapy, Disorder, USD, TEL, Pharmaceutical industry

TEL AVIV, Israel, March 27, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced today that as part of its ongoing collaboration with Clearmind Medicine Inc. (“Clearmind”) (Nasdaq: CMND) (CSE: CMND) (FSE: CWY), a biotechnology company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, Clearmind has submitted a patent application under the international Patent Cooperation Treaty.

Key Points: 
  • TEL AVIV, Israel, March 27, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced today that as part of its ongoing collaboration with Clearmind Medicine Inc. (“Clearmind”) (Nasdaq: CMND) (CSE: CMND) (FSE: CWY), a biotechnology company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, Clearmind has submitted a patent application under the international Patent Cooperation Treaty.
  • The patent application refers to the novel proprietary composition of Clearmind’s MEAI compound (5-methoxy-2-aminoindane) with palmitoylethanolamide (“PEA”), the active ingredient of SciSparc’s proprietary CannAmide™, for preventing and/or treating depression.
  • According to the ResearchAndMarkets.com , the global depression and anxiety disorders treatment market size was estimated to be USD 21.56 billion in 2023 and is expected to reach at USD 41.83 billion by 2034 with a CAGR of 6.21% during the forecast period 2024-2034.
  • Overall, as part of this collaboration, nine other patent applications have been filed by Clearmind with the USPTO for various compositions, including the composition of SciSparc’s CannAmide™with Clearmind’s MEAI compound for the treatment of alcohol use disorder, cocaine addiction and obesity and its related metabolic disorders.

Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States

Retrieved on: 
Wednesday, March 27, 2024
FACC, Obesity, Gastroparesis, Metoclopramide, Diabetes, Patient, Volunteering, MD, IND, Nausea, European, Investigational New Drug, Safety, Pharmacokinetics, Phase, Conditional sentence, Vomiting, FDA, Bloating, Pharmaceutical industry

Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.

Key Points: 
  • Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.
  • Renexxion and Dr. Falk Pharma will now expand patient enrollment for the ongoing global multi-center 320 patient placebo-controlled Phase 2b MOVE-IT study in gastroparesis to clinical sites in the United States (ClinicalTrials.gov ID: NCT05621811).
  • Furthermore, naronapride has already demonstrated dose-dependent accelerated gastric emptying in a GI transit study of healthy human volunteers.
  • We are aligned in our belief in the transformative power of naronapride to revolutionize treatment for gastroparesis patients and its ability to reshape the gastroparesis treatment landscape.”

iBio and AstralBio Announce Transformative AI drug discovery Collaboration to Rapidly Develop Novel Antibodies for Obesity and Cardiometabolic Diseases

Retrieved on: 
Wednesday, March 27, 2024
Transforming growth factor beta, Eli Lilly, Atrophy, DVM, Obesity, Drug discovery, Exercise, Partnership, Patient, SAN, EDT, Learning, Entrepreneurship, IND, Antibody, Drug development, PIPE, Pharmaceutical industry

BRYAN, Texas and SAN DIEGO, March 27, 2024 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”) announces today that it has entered into a collaboration agreement with AstralBio, Inc. (“AstralBio”) to discover, engineer and develop novel antibodies to treat obesity and other cardiometabolic conditions.

Key Points: 
  • Yesterday, iBio announced the closing of a $15 million private placement financing with ADAR1 Capital Management, Lynx1 Capital Management, Ikarian Capital and other institutional investors.
  • The company will use a portion of the net proceeds to support new partnerships, such as this collaboration with AstralBio.
  • The goal of this transformative collaboration is to rapidly build a novel, best-in-class cardiometabolic disease portfolio by combining iBio’s ability to create antibodies against hard-to-drug targets with AstralBio’s significant biologics experience and drug development expertise.
  • iBio has the exclusive option to license three (3) cardiometabolic targets from AstralBio and will receive the rights to develop, manufacture and commercialize those targets upon exercise.