K-757

Kallyope, a New York City biotech that has raised about $480 million over the past decade, quietly released results of its Phase 2 study in obesity in an update to the US federal trials database on Wednesday. The study evaluated an experimental pill, dubbed K-757, both alone and in combination with another oral Kallyope asset, K-833. After 13 weeks of treatment, patients given K-757 monotherapy lost 1.6% of their body weight, the database update reveals, and those in the combo arm lost 2.9%. The monotherapy did not reach statistical significance versus placebo, but the combo arm did, with a p-value of 0.0008. Placebo recipients shed 0.2% of their body weight. Even so, a 2.7-point delta over placebo is nothing to write home about. Lilly’s pill orforglipron managed roughly 6.5% placebo-adjusted weight loss at 12 weeks, and oral therapies from both Structure Therapeutics and Regor Therapeutics have achieved higher weight loss at the three-month mark than what Kallyope’s products managed. In the K-757 group, 17.6% of patients lost at least 5% of their weight, versus 21.2% of those in the combo cohort. Neither hit significance versus the 11.5% figure with placebo. Doses of both Kallyope’s oral drugs were increased gradually, with K-757 reaching the maintenance dose of 120 mg twice daily on day 22 and K-833 titrated to its maintenance dose of 100 mg twice daily on day 8. Backed by large VC firms like Lux Capital and The Column Group as well as Bill Gates, Kallyope is attempting to develop oral obesity and type 2 diabetes drugs that stimulate secretion of GLP-1 and other satiety hormones and mimic the effects seen after bariatric surgery , according to an announcement from the company when the trial started in the fall of 2023. K-757 and K-833 are so-called nutrient receptor agonists that go after GLP-1, PYY and CCK, among other satiety hormones, Kallyope has said. Other small drug developers have attracted interest in these areas: In the CCK space, Aardvark Therapeutics went public this month, and CinRx Pharma nabbed $73 million last year as its portfolio company CinFina undergoes early-stage testing with a PYY analog derived from Johnson & Johnson. The Phase 2 is a pivotal moment for Kallyope, founded in 2015. The biotech is trying to crack into the hottest, potentially most lucrative area of drug R&D as pharmaceutical giants, mid-cap biotechs and new startups try developing the next wave of obesity medicines behind market leaders Novo Nordisk and Eli Lilly. Investors were likely keenly awaiting the Phase 2 data, which could dictate Kallyope’s next funding steps. The company could be nearing the end of its runway. At the time of its last raise, a $236 million Series D in February 2022, CEO Jay Galeota told Endpoints News that funding would keep the startup’s R&D engine humming for about three years. Then, last January, Bloomberg News reported that Kallyope was exploring an IPO and was reportedly working with JP Morgan on a potential listing in 2024. It didn’t follow through with a Wall Street debut last year. Other biotechs in the clinic with obesity medicines, or with intentions to explore the booming area, have gone public since then. That includes BioAge Labs, Metsera, Aardvark, Fractyl Health and MBX Biosciences. Beyond obesity and type 2 diabetes, Kallyope is also looking at migraine, celiac disease and allergies, among other areas. Kallyope also disclosed plans for a Phase 2b trial in migraine, according to a separate update to the US federal trials database on Wednesday. Elismetrep, the asset in that trial, appears to have come from Mitsubishi Tanabe Pharma, which lists the investigational medicine in its pipeline. Bain Capital is buying the centuries-old Japanese pharma for $3.3 billion . Kallyope is also working on a gastrointestinal partnership with Nxera (formerly Sosei Heptares). In 2018, it also disclosed an obesity and diabetes collaboration with Novo to discover new peptide therapies. Under their collaboration, Novo exercised an option last fall. Well-known investors have swarmed to Kallyope since its founding by Columbia University researchers Richard Axel, Tom Maniatis and Charles Zuker. Its financial backers include Bill Gates, Mubadala Investment Company, The Column Group, Lux Capital, Alexandria Venture Investments and other blue-chip names. Leading the biotech is Galeota, a 28-year Merck veteran. Former Roche CEO and chair Franz Humer is Kallyope’s board chair.