Lebrikizumab

Dive Brief:Apogee Therapeutics on Monday said an experimental antibody drug its developing significantly reduced signs and symptoms of atopic dermatitis, a common form of eczema, when compared to a placebo in a mid-stage trial.The study randomized 123 people with moderate-to-severe atopic dermatitis to receive either placebo or Apogees drug. Results showed the treatment reduced the severity of symptoms at week 16, meeting the trials primary and secondary endpoints.Analysts viewed the data as competitive to that of Sanofi and Regenerons Dupixent and Eli Lillys Ebgylss, which are both approved for atopic dermatitis in the U.S. Apogees drug could be dosed less frequently than either, however, potentially offering an advantage.Dive Insight:Atopic dermatitis is a chronic condition that causes dry, irritated and itchy skin. Anti-inflammatory treatments such as corticosteroids or monoclonal antibodies like Dupixent and Ebglyss are often used.Apogees injection, dubbed APG777, has been closely watched by investors after early data revealed by the company last year hinted at the drugs potential.APG777 has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing benefiting patients, providers, and payers, Apogee CEO Michael Henderson said in a statement, adding that the results de-risks APG777s path to approval.In the Phase 2 study, 123 adults with moderate-to-severe atopic dermatitis received either placebo or a 720 mg dose of APG777 at the beginning of the trial and at week 2. Patients in the drug arm then received a 360 mg dose at weeks 4 and 12. Patients who benefited could then receive maintenance dosing, data from which Apogee plans to use to evaluate three- and six-month dosing.After 16 weeks, APG777 reduced disease severity by 71%, as measured by a commonly used scale, versus 34% among those on placebo.Of the adults who received APG777, 67% achieved 75% skin clearance on that scale, compared to about 25% of those on placebo. In a note to clients Monday, Stifel analyst Alex Thompson that that finding was meaningfully better than Dupixent and Ebglyss, which recorded 48% to 52% and 52% to 59%, respectively.Ultimately, we think the totality of the data support APG777 as a highly-competitive, derisked drug in atopic dermatitis, and Type 2 allergic diseases more broadly markets where there remains significant strategic interest, Thompson wrote.The drug had an acceptable safety profile, according to Apogee. The most common side effects reported were non-allergic conjunctivitis, upper respiratory tract infections and nasopharyngitis, although rates were low. The rare of discontinuations for side effects among APG777-treated patients was also low at 2.4%.A second part of the Phase 2 study is still being conducted, with data expected by the middle of next year. Apogee is also testing another drug candidate versus Dupixent in a Phase 1b study. '

Eli Lilly and AstraZeneca landed at the top of IDEA Pharma's annual Innovation Index and Invention Index rankings, respectively. As Eli Lilly and Novo Nordisk continue to go in opposite directions in their diabetes and obesity market rivalry, so too have they changed positions in the annual IDEA Pharma Innovation Index, which ranks (PDF) the most transformative companies in the biopharma industry.While Lilly advanced from fourth place in 2024 to the top spot this year, it has supplanted last year's champion Novo, which tumbled all the way to eighth place. It’s a familiar perch for Lilly, which earned IDEA’s No. 1 slot in 2019 and 2021.This is the 14th year that IDEA, a pharmaceutical industry consulting firm based in London, has conducted the analysis. In 2019, IDEA added an annual Invention Index, which was topped by AstraZeneca for the third time in the last four years.In conducting its Innovation ranking, IDEA asks two questions: Who in the industry is at the forefront of innovation and what are they doing to achieve this? Additionally, if two biopharma companies were given the same molecule in early phase, which would better develop and launch it and why?In ranking Lilly No. 1, IDEA cited the FDA approvals of obesity drug Zepbound for obstructive sleep apnea, Kisunla for Alzheimer’s disease and Ebglyss for atopic dermatitis, each of which came in the second half of 2024.IDEA also recognized Lilly’s $3.2 billion buyout of Morphic to expand its immunology portfolio and its creation of the LillyDirect platform, which “reflects the company’s commitment to improving patient access and affordability by streamlining therapy delivery and reducing insulin costs.”On the flip side, in addition to falling into No. 8 on the Innovation Index, Novo plummeted to last place in the Invention Index. In both categories, IDEA ranks the industry’s top 30 companies.Novo’s declining fortunes are reflected in a market cap slide from $640 billion in July of last year to its present figure of $293 billion. Last week, the company announced the departure of eight-year CEO Lars Fruergaard Jørgensen.  Also receiving high marks in the Innovation rankings were No. 2 Merck, which jumped from the 10th slot largely because of the continued progression of the development of megablockbuster Keytruda. Third-place AZ and fourth-place Roche rose from Nos. 7 and 8, respectively, while Pfizer, which claimed consecutive titles in 2022 and 2023 for its rapid development of COVID-19 products, came in at No. 5. Also making notable jumps were No. 6 Regeneron, from 15th place, No. 7 UCB, which vaulted from outside of the top 20, and No. 10 Novartis, which was up from 17th place.UCB’s leap was fueled by “significant advancements in immunology, neurology and rare diseases,” IDEA wrote, citing advancements with Bimzelx in inflammatory conditions. "With a pipeline that spans high-need therapeutic areas, UCB has re-established itself as a resilient and innovative player, leveraging differentiated biologics and cutting-edge research to address unmet patient needs,” IDEA CEO Mike Rea said in a release.While IDEA’s Innovation Index measures how well companies perform in bringing new medicines to market and commercializing them, its Invention Index examines the breadth and depth of novel agents currently being developed within the top 30 pharma pipelines. The Invention Index provides a more forward-looking view of who is developing medicines that matter, embracing science and innovations in R&D. AZ’s recent dominance of the category is owed to its deep portfolio across several disease areas, including oncology, evidenced by the success and additional potential of blockbusters Tagrisso, Imfinzi and Enhertu across multiple cancer types.AZ replaced Johnson & Johnson in the top spot, with J&J falling to second place this year, one notch in front of Moderna. As they did in the Innovation Index, Roche and Regeneron also made significant leaps, from No. 17 and No. 8, respectively, last year, to tie for fourth place. Jumping from the teens into the top 10 were No. 8 GSK, as well as BeiGene and Boehringer Ingelheim, which tied for 10th place. Others in the Invention Index top 10 were No. 6 Lilly, No. 7 Merck and No. 9 Pfizer.In addition to Novo placing last in the Invention Index, others who performed poorly in the rankings were Merck KGaA, which placed No. 30 in Innovation and No. 26 in Invention. Takeda also was in the bottom five in both categories. Bayer, Biogen, AbbVie and Otsuka were in the bottom 10 in both categories.