Crohn Disease

Sionna Therapeutics and Odyssey Therapeutics have joined Metsera and Maze in an attempt to go public via the still rocky IPO route. The biotechs, focused on cystic fibrosis and immunology respectively, filed for their initial public offerings on Friday evening. Sionna and Odyssey departed last week’s annual JP Morgan Healthcare Conference with plans for public life as $SION and $ODTX . They join the Nasdaq queue alongside obesity drug developer Metsera and kidney disease startup Maze , which has spun out other companies and formed joint ventures over the years. None of the IPO hopefuls have yet outlined the size of their planned debuts. If all four biotechs follow through with their plans, they’d create a buzzy start to 2025 compared to the relatively dry IPO market of the past few years. The new entrants Sionna and Odyssey are both well-funded, clinical-stage biotechs with experienced management teams, ticking most of the boxes that public market investors seek for drug development startups in the current IPO environment. Last year, Boston-based Sionna in-licensed three cystic fibrosis drug candidates from AbbVie, just months after disclosing a $182 million Series C that would take it through 2026, CEO Mike Cloonan told Endpoints News last July. Cloonan was a long-time Biogen executive and Sage Therapeutics operating chief before joining Sionna in spring 2021. New details on the AbbVie deal were revealed in Sionna’s S-1 paperwork, which was filed on 17 January. AbbVie got $5 million upfront and $8.6 million worth of common stock. The pharma giant could also get up to $360 million in development and commercial biobucks, plus up to $130 million in commercial and sales-based milestones, according to the S-1 filing . Sionna had $180 million in cash, equivalents and marketable securities at the end of September, according to the filing. The mid-stage biotech spent about $43 million on R&D in the first nine months of 2024, a $12 million jump over the same period the prior year, per the S-1. Sionna has raised about $330 million since its 2019 founding. RA Capital owns the largest chunk of the biotech at 29.2%. TPG Growth holds 17.4%, Atlas Venture owns 11.4% and OrbiMed maintains a 9.9% stake. OrbiMed is also one of the largest stakeholders in Odyssey. SR One is the biggest shareholder at 16.2% followed by OrbiMed (14.3%), Fidelity (6.7%) and Foresite Capital (6%), according to Odyssey’s S-1 filing . Odyssey is developing small molecule therapies for ulcerative colitis, Crohn’s disease, atopic dermatitis, systemic sclerosis and other indications. It’s also creating protein therapeutics for vitiligo, type 1 diabetes, systemic lupus erythematosus and asthma. The preclinical asthma program is part of the burgeoning TSLP arena. Gary Glick, a chemistry professor-turned-serial entrepreneur, leads Odyssey. The biotech startup formed in 2021 and quickly disclosed three successive megaround financings, most recently a $101 million Series C in December 2023. Glick is also a co-founder of Scorpion Therapeutics. During last week’s JPM, Eli Lilly said it would buy Scorpion for up to $2.5 billion . Odyssey spent $81 million on R&D in the first nine months of 2024, a $5 million decrease compared with the same period of 2023. The company had about $155 million in cash, equivalents and marketable securities at the end of September.

THURSDAY, Jan. 16, 2025 -- The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn disease in adults, according to a press release from Eli Lilly and Company. Omvoh targets interleukin-23p19, which contributes to intestinal inflammation. Omvoh is the first biological treatment for Crohn disease to have disclosed two-year phase 3 efficacy data at the time of approval in more than 15 years. The approval is based on results of the phase 3 VIVID-1 study in adults with moderately to severely active Crohn disease with inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics. Patients were randomly assigned to placebo or Omvoh; those in the placebo group who did not achieve clinical response at 12 weeks were switched to Omvoh treatment. Both primary end points were achieved; clinical remission at one year was achieved by 53 and 36 percent of patients treated with Omvoh and placebo, respectively, and visible healing of the intestinal lining at one year occurred in 46 and 23 percent of patients treated with Omvoh and placebo, respectively. "With Omvoh approved in both Crohn's disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly's ongoing commitment to elevate care and improve outcomes for patients," Daniel M. Skovronsky, M.D., Ph.D., chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, said in a statement. Approval of Omvoh was granted to Eli Lilly. Mote Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Once Humira biosimilars entered the US markets in 2023, drug revenues declined by 32% for AbbVie. Image credit: Skorzewiak / Shutterstock AbbVie executives say the company’s immunology drugs Skyrizi and Rinvoq are expanding their reach in the inflammatory bowel disease (IBD) as the market for Humira biosimilars heats up. For 20 years, AbbVie’s Humira (adalimumab) was one of the world’s top-selling products, but its patent expiry, and the subsequent entry of biosimilars in January 2023 resulted in a 32% decline in sales of Humira in 2023, accompanied by a 7% drop in the company’s total revenue for that year. From the biologics’ first US Food and Drug Administration (FDA) approval in 2002 until 2023, Humira generated $187bn in revenues for AbbVie. Speaking at the JP Morgan Healthcare Conference 2025 in San Francisco, CEO Rob Michael said that despite the Humira pull back, only about 20% of patients have been moved onto Humira biosimilars while many physicians have moved patients to AbbVie’s other immunology assets, Skyrizi (risankizumab) and Rinvoq (upadacitinib). Skyrizi is an interleukin-23 (IL-23)-inhibiting monoclonal antibody while Rinvoq is a small molecule Janus kinase (JAK) inhibitor. The company is also investigating the potential of both biologics in combination with each other or in combination with other approved therapies. In 2024, AbbVie reported that Skyrizi and Rinvoq accounted for about $5bn in growth, with the company highlighting how the two products have captured around 50% of the market share in IBD indications such as Crohn’s disease and ulcerative colitis. The company said it is keeping an eye on TNF-like ligand 1A (TL1A) therapies to be used in combination with Skyrizi which it hopes could become the new standard of care. Pipeline prospects discussed at JP Morgan Healthcare Conference 2025 AbbVie also spoke about the disappointing data from Phase II studies of emraclidine in schizophrenia – a drug acquired as part of its $9bn acquisition of Cerevel. The company unveiled data in November 2024 from the EMPOWER-1 and EMPOWER-2 trials, neither of which met their primary endpoint of change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6. The company said that a more extensive study of the data has shown a deep placebo effect at certain trial sites, with a signal seen when looking beyond these sites – however it remains a modest signal compared to the Phase Ib trial. The company will now initiate a multiple ascending dose study given the therapy’s strong safety profile and high tolerance to see if higher doses could be investigated as a monotherapy in another Phase II study. The ongoing Phase II studies of emraclidine as an adjunct therapy will continue. AbbVie also discussed trials of tavapadon in Parkinson’s disease, which met the primary endpoint in the pivotal Phase III TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26. The company believes this could exceed expectations from the disease model and that it will be key in driving growth for the company in the next decade. Earlier this week, AbbVie announced an option-to-license agreement with Simcere Zaiming for the development of an investigational drug candidate, SIM0500. Simcere Zaiming will gain an upfront payment from AbbVie and is eligible for option fees and milestone payments that could total up to $1.055bn. Also, in news for AbbVie this week, AbCellera has expanded its existing partnership with the company to include the discovery of T-cell engagers (TCE) for oncology applications.