Obesity

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.

The China-to-US experimental medicine pipeline is ballooning: yet another US-based biotech formed around a candidate from China’s Keymed Biosciences on Monday. Life sciences investment firm RTW has set up a company called Prolium to take forward a CD20×CD3 bispecific known as CM355 outside Asia, the companies said in a press release and Hong Kong Stock Exchange filing . Prolium will get rights to develop the antibody in both oncology and non-oncology indications in exchange for $17.5 million upfront and up to $502.5 million in biobucks. Keymed will split its earnings with partner Beijing InnoCare. The companies will also get a minority equity stake in the new company, according to the HKEX filing. China-derived drug candidates have featured prominently in the pipelines of recently launched biotechs: four of the 10 megarounds so far this year have gone to biotechs developing such assets. Chengdu-based Keymed is one of the many biopharmas driving the trend, having out-licensed candidates to two new companies earlier this month. Timberlyne Therapeutics emerged with $180 million and Ouro Medicines debuted with $120 million. And last year, Belenos Biosciences broke cover with two Keymed assets and a former Biohaven executive at the helm. RTW, meanwhile, has recently taken part in similar newco formations. It helped form Kailera Therapeutics , which launched last year with $400 million and a Phase 3-ready obesity drug candidate from China-headquartered Hengrui.

Plozasiran led to an 80% median reduction in baseline of fasting triglyceride level in a Phase III trial. Image credit: Shutterstock/ peterschreiber.media. The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for Arrowhead Pharmaceutical’s plozasiran in the same indication, a month after the first treatment was approved by the regulator for the treatment of familial chylomicronemia syndrome (FCS). The Prescription Drug User Fee Act (PDUFA) action date for Arrowhead’s candidate is 18 November 2025, with the FDA adding that it currently does not intend to hold an advisory committee meeting. FCS is a rare metabolic disease that prevents the body from breaking down fats due to a mutation in lipoprotein lipase. The resulting elevated levels of triglycerides can lead to chronic abdominal pain, diabetes, hepatic steatosis, and acute and potentially fatal pancreatitis. Arrowhead’s NDA is supported by data from the Phase III PALISADE (NCT04998201) trial, along with supportive confirmatory evidence from Phase II studies in the SUMMIT programme. Plozasiran lowered triglyceride levels and reduced acute pancreatitis risk, leading the trial to meet primary and all multiplicity-controlled key secondary endpoints. Plozasiran is an RNA interference (RNAi) therapeutic that cuts the production of apolipoprotein C-III (APOC3), a key regulator of triglyceride metabolism. Last month, Ionis Pharmaceuticals’ Tryngolza (olezarsen) became the first treatment approved for FCS by the FDA. Similar to plozasiran, Tryngolza is also an RNA-based drug designed to reduce the body’s production of APOC3. Direct comparisons between the two drugs have not been made in clinical trials. High-dose Tryngolza led to a 44% placebo-adjusted drop in triglyceride levels from baseline at six months, with this rising to 59% in months six to 12. For 25mg plozasiran, the median reduction in baseline fasting triglyceride level was 80%. Tryngolza is forecast to generate $303m in annual revenue by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology . Arrowhead’s CEO Chris Anzalone said: “We are laser-focused on our ongoing work to ensure an efficient and successful commercial launch this year, pending FDA review and approval.” In addition to targeting FDA approval, Arrowhead stated that it intends to submit applications for plozasiran in FCS treatment to additional regulatory authorities this year. The pharma company also has further lipid-based plans for plozasiran and is investigating the drug in severe hypertriglyceridemia and mixed hyperlipidemia. Moreover, Arrowhead placed a target on the obesity treatment space by advancing two RNAi-based candidates to clinic in August 2024.