University of Copenhagen

Lebrikizumab Shows Promise for Long-Term Management of Atopic Dermatitis in Phase 3 Trial

4 months ago

• Phase 3 trial data demonstrates lebrikizumab's efficacy in managing atopic dermatitis (AD) symptoms over 52 weeks, a significant improvement over the 16-week maintenance shown in previous trials. • Lebrikizumab, a monoclonal antibody inhibiting IL-13, shows potential for reducing skin inflammation and itch, key symptoms of AD, with infrequent dosing options. • The most common side effects reported in the trial were mild and manageable, including conjunctivitis, common cold, and headaches, without leading to treatment discontinuation. • Almirall and Lilly plan to submit regulatory applications to the EU and US, respectively, with potential launch expected after approval in 2023, offering a new first-line systemic treatment option.

Hengrui Pharma's HRS9531 Shows Promising Weight Loss in Phase 2 Obesity Trial

5 months ago

• Hengrui Pharmaceuticals and Kailera Therapeutics reported positive Phase 2 results for HRS9531, a GLP-1/GIP receptor dual agonist, in overweight or obese adults. • Participants receiving the 8 mg dose of HRS9531 achieved a statistically significant 21.1% placebo-adjusted mean weight loss at 36 weeks. • The trial demonstrated a favorable safety profile, with most adverse events being mild and gastrointestinal-related during dose titration. • Hengrui is advancing HRS9531 into Phase 3 clinical trials for obesity and type 2 diabetes in China, with Kailera developing it globally as KAI-9531.

Antag Therapeutics Secures €80 Million to Advance Novel Obesity Therapy

6 months ago

• Antag Therapeutics has secured €80 million in Series A financing to advance the development of AT-7687, a novel therapy targeting obesity. • AT-7687, a once-weekly subcutaneous GIPR antagonist, is designed to enhance weight loss and metabolic benefits when co-administered with GLP-1 therapies. • The financing will support clinical trials of AT-7687, both as a monotherapy and in combination with GLP-1 receptor agonists, with trials beginning early next year. • Antag's approach, based on the discovery of an endogenous GIPR antagonist, aims to improve tolerability and cardiometabolic effects in obesity treatment.

Vyepti Demonstrates Efficacy in Patients with Chronic Migraine and Medication-Overuse Headache

6 months ago

• The RESOLUTION trial demonstrated that Vyepti (eptinezumab) is effective for patients with chronic migraine and medication-overuse headache (MOH). • Patients treated with Vyepti experienced statistically significant reductions in monthly migraine days (MMD) compared to placebo over weeks 1-4. • A significantly greater proportion of patients treated with Vyepti no longer met the diagnostic criteria for chronic migraine or MOH after treatment. • The trial confirmed the early onset of Vyepti’s efficacy, with significant reductions in pain severity and acute medication use.

Weight Loss from GLP-1 Drugs Regained After Discontinuation, Studies Show

6 months ago

• Clinical trials indicate that weight loss achieved with GLP-1 drugs like semaglutide and tirzepatide is often regained after patients stop taking the medication. • Studies such as the Step 1 trial extension and Surmount-4 trial demonstrate significant weight regain despite initial success with GLP-1 agonists. • Experts emphasize that obesity should be treated as a chronic disease, requiring long-term management strategies, similar to hypertension or hyperlipidemia. • Strategies to maintain weight loss after discontinuing GLP-1 drugs are lacking, highlighting the need for individualized approaches and further research.

Outlook Therapeutics Faces Setback in AMD Trial; Other R&D Updates

6 months ago

• Outlook Therapeutics' ONS-5010 failed to meet the noninferiority endpoint in a Phase III wet AMD trial, impacting company shares but BLA resubmission is still planned for early 2025. • The EMA revoked conditional marketing approval for Advanz Pharma's Ocaliva for primary biliary cholangitis (PBC) after a legal challenge failed. • Arovella Therapeutics is advancing ALA-101, a CAR-19-iNKT cell therapy, towards clinical trials for blood cancers and solid tumors, showing enhanced efficacy in preclinical studies.

Vitamin B3 Shows Promise in Reducing Lung Inflammation in COPD Patients

6 months ago

• A recent study reveals that daily intake of vitamin B3 significantly reduces lung inflammation in individuals with Chronic Obstructive Pulmonary Disease (COPD). • The research demonstrated a notable decrease in interleukin 8 (IL-8), a key marker of inflammation, by 53% after six weeks and 63% after 18 weeks. • Vitamin B3 treatment also increased levels of NAD, a chemical that declines with age and DNA damage, suggesting potential benefits against cellular aging. • Researchers plan further studies to validate these findings and explore the long-term efficacy of nicotinamide riboside as a COPD treatment.

GLORIOUS Trial: Exenatide and Restrictive Oxygenation Fail to Improve Outcomes in Cardiac Surgery

6 months ago

• The GLORIOUS trial found that neither exenatide, a GLP-1 receptor agonist, nor restrictive oxygenation during cardiopulmonary bypass improved clinical outcomes after cardiac surgery. • The study, involving 1,389 patients, showed no reduction in mortality or morbidity from renal failure, stroke, or heart failure with either intervention. • Researchers suggest the interventions may have been ineffective due to the low-risk nature of the patient population undergoing elective CABG/AVR procedures. • Future research may focus on testing these strategies in higher-risk patients or exploring alternative interventions to improve perioperative outcomes.

NK2R Agonist Shows Promise for Weight Loss Without Muscle Loss in Preclinical Study

6 months ago

• A novel drug candidate, NK2R, has demonstrated weight loss effects in preclinical studies by targeting appetite and increasing calorie burning. • Unlike semaglutide (Ozempic), NK2R appears to spare muscle mass during weight loss, potentially offering a significant advantage. • The drug acts on a different neural circuit than GLP-1 agonists, targeting the neurokinin 2 receptor to influence blood sugar, body weight, and cholesterol. • Human clinical trials are planned within the next two years to assess the safety and efficacy of NK2R in overweight individuals.

Antag Therapeutics' AT-7687 Receives FDA Clearance for Phase 1 Obesity Trial

7 months ago

• Antag Therapeutics received FDA clearance for its IND application for AT-7687, a GIP receptor antagonist, to treat obesity and cardiometabolic diseases. • A Phase 1 clinical trial will assess the safety, tolerability, and pharmacokinetics of AT-7687 in healthy lean and obese individuals. • The trial will also evaluate AT-7687 in combination with semaglutide, potentially enhancing weight loss effects without gastrointestinal side effects. • AT-7687's development is based on the discovery of a novel human metabolite and supported by human genetic validation.

Wellcome Leap's Quantum for Bio Program Advances Quantum Computing in Healthcare

8 months ago

• Wellcome Leap's Quantum for Bio program has announced Phase 2 finalists, advancing quantum computing applications in healthcare. • Participants receive up to $750,000 to simulate quantum algorithms related to human health applications using classical high-performance computing. • Phase 3 offers up to $5 million for demonstrating significant quantum advancements, focusing on practical applications on quantum devices. • The program aims to revolutionize areas like drug discovery and genomics by integrating quantum computing with biology and healthcare.

Iterum's Oral Sulopenem Faces FDA Decision Amidst Antibiotic Resistance Concerns

8 months ago

• Iterum Therapeutics' oral sulopenem, an antibiotic for uncomplicated urinary tract infections (uUTIs), awaits an FDA decision by October 25. • An FDA advisory committee acknowledged oral sulopenem as an important treatment option, particularly for multi-drug resistant pathogens. • Concerns remain about potential misuse and the need for antibiotic stewardship to prevent further antimicrobial resistance. • Post-marketing surveillance and clear labeling are crucial to ensure responsible prescription and limit off-label use of oral sulopenem.