Tag

Phase 3

All articles tagged with #phase 3

health1 day ago

AstraZeneca cites high placebo response for failed bone disease trial

AstraZeneca reported that its Phase 3 trial for an enzyme replacement therapy targeting hypophosphatasia, a rare genetic bone disease, failed to meet its primary endpoints. The company attributed the failure to a high placebo response, suggesting that the study design rather than the drug's efficacy was the primary issue. This setback follows recent Phase 3 misses for other AstraZeneca therapies, including its ATTR-CM silencer.

via Endpoints News|

#astrazeneca #clinical-trials #enzyme-replacement

health10 days ago•4 min saved

Eli Lilly’s Retatrutide Sets New Weight-Loss Benchmarks in Phase 3 Trials

Eli Lilly’s experimental triple-agonist retatrutide achieved up to 25% weight loss in non-diabetic adults and 18.8% in those with type 2 diabetes in Phase 3 trials. The drug targets GLP-1, GIP, and glucagon, offering benefits beyond weight loss, including improved knee pain, sleep apnea, and blood sugar control, though gastrointestinal side effects remain common.

via ScienceAlert|

#eli-lilly #glp-1 #health

biotech20 days ago

Amgen's Dazodalibep Achieves Phase 3 Success in Sjögren's Disease

Amgen reported that its investigational fusion protein dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's disease, showing significant improvement in systemic disease activity after 48 weeks. The drug targets the CD40 ligand and is being developed for patients with moderate-to-severe symptoms. This success follows a period of setbacks for the company's autoimmune pipeline, including the discontinuation of another Horizon Therapeutics-acquired drug. The FDA currently has no approved treatments for Sjögren's, a condition characterized by dry eyes and mouth but also potentially severe systemic issues. Amgen expects to present detailed data at an upcoming medical conference, while a second Phase 3 trial is expected to conclude in the fourth quarter of 2026.

via Fierce Biotech|

#amgen #autoimmune #biotech

biotech1 month ago•3 min saved

NodThera to enter Phase 3 and rebrand as Rezera

NodThera, a decade-old developer of NLRP3 inflammasome inhibitors, plans Phase 3 trials in 2027 and is undergoing a brand overhaul to Rezera, signaling a strategic pivot for its anti-inflammatory program.

via Endpoints News|

#biotech #clinical-trials #nlrp3

health1 month ago•3 min saved

Novartis Lp(a) Therapy Falls Short in Phase 3 Trial on Cardiovascular Risk

Novartis said pelacarsen lowered lipoprotein(a) but did not reduce the rate of heart attacks, strokes or other major cardiovascular events in the Phase 3 Lp(a)Horizon trial involving 8,323 high-risk patients; full topline results will be presented at a medical meeting, and analysts note deeper Lp(a) suppression or subpopulation effects might still matter for future efforts in this space.

via Fierce Biotech|

#cardiovascular-disease #health #lpa

business1 month ago•2 min saved

Novartis’s pelacarsen setback in Phase 3 Lp(a) trial

Novartis said pelacarsen, an experimental Lp(a)-lowering drug, failed to reduce cardiovascular death or events in the Phase 3 HORIZON trial, marking a major setback for the Lp(a) program and complicating rival efforts from Amgen and Eli Lilly.

via STAT|

#business #cardiovascular #lpa

business1 month ago•2 min saved

AstraZeneca ATTR-CM Trial Setback Upsets Biotech Shuffle

AstraZeneca disclosed a Phase 3 failure of its ATTR-CM silencer, which produced no extra benefit for patients already on a stabilizer, a result that may tilt the market toward stabilizers and ripple through rivals like Alnylam and BridgeBio.

via STAT|

#astrazeneca #attr-cm #business

business2 months ago•3 min saved

Lilly targets 2027 filing for next-gen obesity drug retatrutide after strong Phase 3 results

Eli Lilly said it will file for retatrutide's approval in Q1 2027 after two positive Phase 3 trials showing substantial weight loss and improved glycemic control in adults with obesity and either Type 2 diabetes or cardiovascular disease; the company needs more time to finalize manufacturing data, and retatrutide—a triple-hormone GLP-1/GIP/glucagon drug—could become a key obesity treatment alongside Zepbound and Foundayo.

via CNBC|

#business #eli-lilly #glp-1gipglucagon

business3 months ago•5 min saved

Definium's LSD depression drug DT120 ODT shows best-in-class Phase 3 results

Definium Therapeutics reports topline Phase 3 results for its LSD-based antidepressant DT120 ODT in the 149-patient Emerge trial, showing an 8.1-point placebo-adjusted MADRS reduction at six weeks and a 7.1-point reduction at 12 weeks, with no new safety signals; the company is running a 40-week open-label extension, and has additional Phase 3 readouts for anxiety and depression expected later this year as it charts a potential path to approval for treatment-resistant depression.

via Fierce Biotech|

#business #definium-therapeutics #dt120-odt

health3 months ago•20 min saved

Merck’s TL1A-targeted antibody tulisokibart secures remission in UC Phase 3 induction trial

Merck's tulisokibart, an anti-TL1A monoclonal antibody, met the Phase 3 ATLAS-UC induction-only study’s primary endpoint of clinical remission (Modified Mayo Score at week 12) and key secondary endpoints in adults with moderately to severely active ulcerative colitis, with no safety concerns reported. This marks the first successful Phase 3 remission signal for an anti-TL1A therapy, and results will be presented alongside data from the ongoing Study 1 and shared with regulatory authorities, highlighting the approach's potential against immuno-fibrosis.

via Merck.com|

#health #immuno-fibrosis #phase-3

healthcare4 months ago•2 min saved

Abivax UC drug delivers strong remission in Phase 3, but safety signals spark caution

Abivax’s ulcerative colitis therapy obefazimod showed high remission rates in a 580-patient Phase 3 maintenance trial, with about 51% remission at both 25 mg and 50 mg doses over 44 weeks versus 10.4% with placebo, suggesting strong efficacy. However, the company reported a few cancer cases among treated patients, raising safety concerns and sending shares lower after the results were disclosed.

via statnews.com|

#abivax #cancer-safety-concerns #healthcare

business4 months ago•3 min saved

Lilly’s triple-hormone obesity drug posts strong Phase 3 weight loss, but data gaps temper optimism

Lilly’s triple-G obesity drug retatrutide met primary endpoints in Phase 3 TRIUMPH-1, delivering up to 28.3% weight loss at 80 weeks for the highest dose on the efficacy estimand (vs 2.2% for placebo). On the treatment-regimen estimand, weight losses were 17.6% (4 mg), 23.7% (9 mg) and 25% (12 mg) with placebo at 3.9%. A Week 104 readout for the top dose reached 29.9% among patients who stayed on therapy. The topline did not include sleep apnea or osteoarthritis pain data. Safety showed higher discontinuations at the high dose (11.3% vs 4.9% placebo) and notable dysesthesia (20.9% at high dose); GI adverse events were more common at the low dose. Analysts said the results meet key endpoints but didn’t exceed expectations, and Lilly is eyeing possible FDA submission this year amid competition from Wegovy and other obesity drugs.

via Fierce Biotech|

#business #lilly #obesity

healthcare4 months ago•23 min saved

Lilly's triple-hormone drug retatrutide yields deep, lasting weight loss in Phase 3 obesity study

Eli Lilly announced topline TRIUMPH-1 results for retatrutide, a first-in-class GIP/GLP-1/glucagon triple agonist, in adults with obesity or overweight and comorbidities. Across 4 mg, 9 mg, and 12 mg doses, participants achieved meaningful weight loss at 80 weeks (4 mg: 19.0%, 9 mg: 25.9%, 12 mg: 28.3%), with the 12 mg group averaging 70.3 lb and 45.3% reaching ≥30% weight loss; BMI ≤22 was achieved by 65.3% at Week 80. Some participants with higher BMI continued losing weight in extensions, reaching about 30% total body weight loss over roughly two years. All arms met primary and key secondary endpoints, and the follow-on extension data covered up to 104 weeks. Safety disclosures mirror warnings associated with Lilly's obesity medicines.

via PR Newswire|

#clinical-trial #healthcare #obesity

health4 months ago•23 min saved

Lilly’s retatrutide drives sustained, substantial weight loss in Phase 3 obesity trial

In the TRIUMPH-1 Phase 3 trial, Lilly’s triple hormone agonist retatrutide produced clinically meaningful weight loss across all dose groups over 80 weeks: 12 mg yielded an average 70.3 lb loss (28.3%) with 45.3% achieving ≥30% weight reduction, and 65.3% reached BMI 22 at Week 80; 9 mg achieved 64.4 lb (25.9%) and 4 mg 47.2 lb (19.0%). An extension up to 104 weeks showed continued weight loss in some participants, including those with higher baseline BMI. The data support retatrutide’s potential as a non-surgical obesity treatment, with detailed safety labeling included in the release.

via investor.lilly.com|

#health #lilly #obesity

healthcare4 months ago•23 min saved

Merck’s Sac-TMT Phase 3 Trial Hits Dual Endpoints in Endometrial Cancer

Merck announced TroFuse-005, a global Phase 3 trial, met its dual primary endpoints of overall survival and progression-free survival for sacituzumab tirumotecan (sac-TMT) versus physician’s choice chemotherapy in advanced or recurrent endometrial cancer after platinum-based therapy and anti‑PD-1/L1 therapy; interim analysis showed statistically significant OS and PFS improvements and a positive objective response rate, with a safety profile consistent with prior studies. The TroFuse program spans 17 global Phase 3 trials across multiple tumor types, highlighting Merck’s leadership in TROP2-directed ADCs in women’s cancers.

via Merck.com|

#endometrial-cancer #healthcare #phase-3