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Phase 3

All articles tagged with #phase 3

Lilly’s triple-hormone obesity drug posts strong Phase 3 weight loss, but data gaps temper optimism
business4 days ago

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
Lilly's triple-hormone drug retatrutide yields deep, lasting weight loss in Phase 3 obesity study
healthcare5 days ago

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
Lilly’s retatrutide drives sustained, substantial weight loss in Phase 3 obesity trial
health5 days ago

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
Merck’s Sac-TMT Phase 3 Trial Hits Dual Endpoints in Endometrial Cancer
healthcare8 days ago

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
Intellia's in vivo CRISPR therapy hits Phase 3 for hereditary angioedema, signaling a potential one-time treatment
science29 days ago

Intellia's in vivo CRISPR therapy hits Phase 3 for hereditary angioedema, signaling a potential one-time treatment

Intellia Therapeutics said its one-time, in vivo CRISPR-based treatment for hereditary angioedema met its Phase 3 primary endpoint, reducing attacks by 87% vs placebo and achieving 62% attack-free patients at six months after a liver-directed infusion, with a favorable safety profile. The company has started a rolling FDA submission and targets a U.S. launch in 2027 if approved.

via CNBC|
#crispr#gene-editing#hereditary-angioedema
Nektar's rezpeg shows promising hair regrowth in alopecia, moving toward Phase 3
biotech1 month ago

Nektar's rezpeg shows promising hair regrowth in alopecia, moving toward Phase 3

Nektar Therapeutics reported that extended treatment with its experimental drug rezpeg led to meaningful hair growth in severe alopecia areata after one year, with 27% of participants reaching SALT Score 20 (80%+ scalp coverage). The response is comparable to or better than low-dose Olumiant, though not tested head-to-head, and Nektar plans to begin a Phase 3 trial later this year.

via statnews.com|
#alopecia-areata#biotech#hair-growth
New Four-Dose Lyme Vaccine Shows About 70% Protection
health1 month ago

New Four-Dose Lyme Vaccine Shows About 70% Protection

Pfizer and Valneva announced phase 3 results for PF-0730740, a four-dose Lyme disease vaccine that achieved about 70% efficacy in preventing infection among people aged 5+ across the US, Canada, and Europe. The regimen requires four injections (two two months apart, then months five–nine, then one year later) and the vaccine is not yet approved; its impact on disease complications is unknown, but it could offer meaningful protection for those in endemic areas while continued tick-prevention steps remain important.

via Women's Health|
#health#lyme-disease#pfizer
AZ's tozorakimab delivers COPD benefit across populations in Phase 3
healthcare1 month ago

AZ's tozorakimab delivers COPD benefit across populations in Phase 3

AstraZeneca's anti-IL-33 antibody tozorakimab posted positive Phase 3 results in COPD (Oberon and Titania), reducing the annualized rate of moderate-to-severe exacerbations versus placebo in former smokers and showing benefit across the overall population, with a favorable safety profile. The drug’s supposed differentiation comes from complete inhibition of ST2 and RAGE/EGFR signaling, unlike rivals Roche and Sanofi/Regeneron’s IL-33 blockers that produced mixed results. AZ plans to present full data at an upcoming meeting and is pursuing two additional Phase 3 trials (Prospero, Miranda), while maintaining a target of potentially $3–5 billion in peak sales if approved.

via Fierce Biotech|
#astrazeneca#copd#healthcare
Lilly's retatrutide delivers strong A1C drops and meaningful weight loss in first Phase 3 Type 2 diabetes trial
health2 months ago

Lilly's retatrutide delivers strong A1C drops and meaningful weight loss in first Phase 3 Type 2 diabetes trial

Lilly reports positive topline results from TRANSCEND-T2D-1, a Phase 3 trial of retatrutide, a once-weekly triple hormone receptor agonist (GIP, GLP-1, glucagon), showing up to a 2.0% reduction in A1C and about 17% body-weight loss at 40 weeks versus placebo, with dose-dependent effects and continued weight loss through the treatment period. The most common side effects were gastrointestinal (nausea, diarrhea, vomiting) largely during dose escalation, with some dysesthesia but generally manageable. Results met primary and key secondary endpoints and will be detailed at the ADA Scientific Sessions in June; Lilly plans to publish additional data from the retatrutide program over the next year.

via Eli Lilly|
#a1c#health#phase-3
Vertex reports strong Week 36 interim results for povetacicept in IgA nephropathy
health2 months ago

Vertex reports strong Week 36 interim results for povetacicept in IgA nephropathy

Vertex’s povetacicept demonstrated robust Week 36 interim efficacy in the Phase 3 RAINIER trial for IgA nephropathy, including a 52.0% reduction in 24-hour UPCR (49.8% versus placebo, P<0.0001), a 77.4% reduction in serum Gd-IgA1 (79.3% versus placebo; P<0.0001), and 85.1% hematuria resolution versus 23.4% with placebo (61.7-point difference; P<0.0001). The drug was generally safe and well tolerated. Vertex plans full BLA submission by end of March for potential accelerated FDA approval, with final efficacy analysis scheduled at two years through Week 104.

via Vertex Pharmaceuticals Newsroom|
#baff-april#health#iga-nephropathy
FDA orders phase 3 for Huntington's gene therapy, delaying uniQure's path to approval
health2 months ago

FDA orders phase 3 for Huntington's gene therapy, delaying uniQure's path to approval

The FDA rejected uniQure's plan to file AMT-130 using phase 1/2 data with an external control and demanded a prospective, randomized, sham-controlled phase 3 trial, dampening near-term approval hopes and triggering a strategic review by the company; uniQure will discuss trial designs with the FDA and add a four-year durability analysis to the phase 1/2 data.

via Fierce Biotech|
#amt-130#fda#health
Compass’s psilocybin therapy advances toward FDA nod in severe depression
biotech3 months ago

Compass’s psilocybin therapy advances toward FDA nod in severe depression

Compass Pathways reports positive Phase 3 results for its psilocybin-based treatment COMP360 in two trials for severe depression, suggesting potential FDA approval, though full data are needed to confirm the magnitude of benefit; if approved, it could become the first psilocybin product on the market, following Spravato (ketamine derivative).

via statnews.com|
#biotech#comp360#compass-pathways
Novavax's COVID-Influenza Vaccine Candidates Demonstrate Strong Immune Response in Phase 3 Trial
health11 months ago

Novavax's COVID-Influenza Vaccine Candidates Demonstrate Strong Immune Response in Phase 3 Trial

Novavax announced that its COVID-19-Influenza combination and stand-alone influenza vaccines elicited strong immune responses and were well tolerated in a Phase 3 trial involving adults aged 65 and older, with results comparable to existing licensed vaccines, supporting further development and partnership discussions.

via Novavax Investor Relations|
#covid-19#health#influenza