Lipid metabolism

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration to License and Develop Portfolio of Dong-A's Cardio-Metabolic Therapies

Retrieved on: 
Thursday, September 15, 2022

"The acquisition of these two cardiometabolic assets marks a seismic shift for NeuroBo, providing us with a highly promising, diversified pipeline with several upcoming value inflection points in the NASH and obesity space -- areas with enormous market opportunity," stated Gil Price, M.D., President and Chief Executive Officer of NeuroBo. "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo. Dong-A is dedicated to our success and we are grateful it has also committed to provide continued support to facilitate the clinical development of the licensed assets. Once the transaction has closed, which is contingent upon certain closing conditions, we will be uniquely positioned to initiate a phase 2a study of DA-1241 in NASH in the first half of 2023, with data expected in the second half of 2024. We also intend to initiate a phase 1a safety study of DA-1726 in the first half of 2023, for which data is expected in the second half of 2023. We are truly excited about the prospects of NeuroBo as we transition to a cardiometabolic company across the large and growing markets of obesity and NASH."

Key Points: 
  • Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies.
  • Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea.
  • "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo.
  • However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so.

CymaBay Therapeutics Hosting Virtual Analyst Day on September 22

Retrieved on: 
Wednesday, September 14, 2022

NEWARK, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that management will host a virtual analyst day on seladelpar, the company’s lead asset in development for patients with the autoimmune liver disease, primary biliary cholangitis (PBC) on Thursday, September 22, 2022 at 10:30 am Eastern Time.

Key Points: 
  • CymaBays seladelpar is a potent, selective, orally active delpar or PPAR agonist, in late-stage development for patients with PBC.
  • PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000) over the age of 40.
  • The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients.
  • CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

New Long-Term Safety and Efficacy Data Presented with Paltusotine in Participants Living with Acromegaly

Retrieved on: 
Tuesday, September 6, 2022

SAN DIEGO, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals (Nasdaq: CRNX) today announced that Monica R. Gadelha, MD, PhD, professor of endocrinology at the Medical School of the Universidade Federal do Rio de Janeiro and a principal investigator in the Phase 2 ACROBAT program, presented new data from the planned two-year interim analysis of the ACROBAT Advance open label extension (OLE) study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM).

Key Points: 
  • This preliminary data, combined with the preference participants had for oral paltusotine over the injected standard-of-care, speaks to the potential paltusotine may have as a long-term therapy for acromegaly.
  • Dr. Gadelha will present an additional poster of the Advance OLE data at the European Neuroendocrine Association (ENEA) meeting.
  • That presentation, titled Long-Term Treatment with Oral Paltusotine for Acromegaly: Results from the ACROBAT Advance study will be made on September 9th.
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine.

New Long-Term Safety and Efficacy Data for Investigational Compound Paltusotine to be Presented at the Brazilian Congress of Endocrinology and Metabolism

Retrieved on: 
Friday, September 2, 2022

Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone.

Key Points: 
  • Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone.
  • Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2).
  • In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine.
  • All of the companys drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts.

Study Published in JHEP Reports Shows Efruxifermin Rapidly Improved Fibrosis in Cirrhotic NASH patients After 16 Weeks of Treatment

Retrieved on: 
Wednesday, August 24, 2022

SOUTH SAN FRANCISCO, Calif., Aug. 24, 2022 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced that results from Cohort C of its Phase 2a BALANCED trial in non-alcoholic steatohepatitis (NASH) have been published in JHEP Reports. Study results showed that efruxifermin (EFX) was well-tolerated in this cohort of patients with compensated cirrhosis, similar to results observed in the BALANCED main study of patients with pre-cirrhotic NASH.

Key Points: 
  • Study results showed that efruxifermin (EFX) was well-tolerated in this cohort of patients with compensated cirrhosis, similar to results observed in the BALANCED main study of patients with pre-cirrhotic NASH.
  • Over 16 weeks of treatment, liver stiffness and serum markers of fibrosis significantly decreased compared to baseline.
  • EFX treatment also improved whole-body metabolism, with significant improvement in lipoprotein profile and decrease in HbA1c.
  • EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH (F2-F3 fibrosis), and the SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis, compensated).

Boston Heart Diagnostics Launches LipidSeq™-- An NGS Test for Common Genetic Disorders of Lipid Metabolism

Retrieved on: 
Wednesday, August 17, 2022

This saliva-based NGS test identifies the most common genetic causes of lipid and lipoprotein disorders.

Key Points: 
  • This saliva-based NGS test identifies the most common genetic causes of lipid and lipoprotein disorders.
  • Boston Heart Diagnostics announces the launch of LipidSeq, a revolutionary genetic test for cardiovascular disease.
  • Boston Heart is the only commercial laboratory able to test biochemical and genetic contributors when diagnosing inherited disorders of lipid metabolism (Reference: Schaefer EJ, Geller AS, Endress G. The biochemical and genetic diagnosis of lipid disorders.
  • For more information on Boston Heart Diagnostics, please visit www.BostonHeartDiagnostics.com
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Vital Nutrients Launches First-to-Market Vegan Omega with SPMs

Retrieved on: 
Thursday, August 4, 2022

 MIDDLETOWN, Conn., Aug. 4, 2022 /PRNewswire/ -- Vital Nutrients, a leading practitioner-founded nutritional supplement company dedicated to making a positive impact on the health of people and the planet, today announc­ed the launch of its latest innovative formulation, Ultra Pure® Vegan Omega SPM+. This high-performance vegan fish oil alternative provides the most biologically active form of specialized pro-resolving mediators (SPMs), plus 400 mg of triglyceride form omega-3s from sustainably sourced, plant-based algal oil concentrate in mini vegan softgels.*

Key Points: 
  • This high-performance vegan fish oil alternative provides the most biologically active form of specialized pro-resolving mediators (SPMs), plus 400 mg of triglyceride form omega-3s from sustainably sourced, plant-based algal oil concentrate in mini vegan softgels.
  • Vital Nutrients holds the exclusive position on this form of algal-based triglyceride DHA/DPA-derived specialized pro-resolving mediators (SPMs), for better tolerance and absorption, and SPMs specific to DHA + DPA.
  • "Our new Vegan Omega SPM+ delivers a first of its kind vegan algae omega formulation, in a capsule that is 40% smaller than traditional fish oils for improved patient compliance."
  • In accordance with Vital Nutrients' commitment to clean supplements, Ultra Pure Vegan Omega SPM+ is free of gluten, dairy, soy, peanut, tree nut, fish and egg, and contains no artificial flavors, colors, sweeteners, coatings or binders.

CymaBay Completes Enrollment for the RESPONSE Global Phase 3 Study Evaluating Seladelpar for Patients with Primary Biliary Cholangitis

Retrieved on: 
Monday, August 1, 2022

RESPONSE is a 52-week, placebo-controlled, randomized study that targeted enrollment of 180 patients recruited in over 20 countries.

Key Points: 
  • RESPONSE is a 52-week, placebo-controlled, randomized study that targeted enrollment of 180 patients recruited in over 20 countries.
  • RESPONSE provides an opportunity to gather the scientific evidence for seladelpars potential to change the treatment paradigm for patients with PBC.
  • Completing study enrollment in the midst of the COVID-19 pandemic reflects the enormous level of commitment by our study sites around the world as well as PBC patients who desire better treatment options.
  • RESPONSE (NCT04620733) is a 52-week, placebo-controlled, randomized, global phase 3 study to evaluate the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC).

TruOliv™ Production Gets New Carbon Neutral Seal

Retrieved on: 
Thursday, July 21, 2022

LANDING, N.J., July 21, 2022 /PRNewswire/ -- Dolcas Biotech, LLC.'s desert-grown TruOliv™ organic olive leaf and fruit extract has been newly minted with Zero-Carbon certification. The new seal endorses the company's commitment to environmental welfare as Dolcas unveils the new liquid beadlet encapsulation formulation for its prized olive extract.

Key Points: 
  • 's desert-grown TruOliv organic olive leaf and fruit extract has been newly minted with Zero-Carbon certification.
  • The new seal endorses the company's commitment to environmental welfare as Dolcas unveils the new liquid beadlet encapsulation formulation for its prized olive extract.
  • The new label asserts compliance with PAS-2060the only internationally recognized certification for organizational carbon neutrality.
  • Some of the regenerative systems employed in the production of TruOliv include recently installed drip-irrigation systems that avert unnecessary loss of water.

DGAP-News: APONTIS PHARMA rolls out new Single Pill for secondary prophylaxis

Retrieved on: 
Wednesday, July 6, 2022

APONTIS PHARMA AG (Ticker APPH / ISIN DE000A3CMGM5 ), a leading pharmaceutical company specializing in Single Pills in the German market, is fully on track to achieve its goals.

Key Points: 
  • APONTIS PHARMA AG (Ticker APPH / ISIN DE000A3CMGM5 ), a leading pharmaceutical company specializing in Single Pills in the German market, is fully on track to achieve its goals.
  • Today, the Single Pill Company announces the rollout of the Single Pill RosuASS in July.
  • With this Single Pill, APONTIS PHARMA addresses the secondary prophylaxis of the group of patients with cardiovascular events in Germany and has thus been able to realize all three targeted market rollouts in financial year 2022.
  • Since 2013, APONTIS successfully launched several Single Pill products alone for cardiovascular indications such as hypertension, hyperlipidemia and secondary prevention.