Kallyope has slipped out results from a phase 2 trial of its obesity candidates, linking the combination of the two oral prospects to weight loss of 2.9% after 13 weeks of treatment.
The data, which were uploaded to ClinicalTrials.gov and first reported by Endpoints, suggest Kallyope’s cocktail will struggle to compete on weight loss. Novo Nordisk linked its oral amylin and GLP-1 receptor co-agonist to 13.1% weight loss after 12 weeks. Kallyope’s K-757 and K-833 work differently than GLP-1 drugs, acting on G-protein coupled receptors 40 and 119, respectively.
Tolerability is one way molecules that drive less weight loss could carve out a niche. The available data suggest Kallyope’s combination is more tolerable than some GLP-1 agonists, with the rates of nausea, 51.9%, and vomiting, 23.1%, coming in well below the figures for Novo’s amycretin, for example. The Kallyope update lacks a breakdown of the severity of the adverse events.
The publication of the data comes shortly after Kallyope changed its public pipeline. Sometime between Dec. 24 and Feb. 13, the biotech removed the metabolism program K-833 from its pipeline and deleted an entire section focused on gastrointestinal conditions such as celiac diseases. Kallyope also flipped the order of its pipeline, moving the neurological section to the top and dropping obesity programs down.
K-757 is still the most advanced program but the neurological disorder candidate K-304 is now at the top of the pipeline. Kallyope’s pipeline lists K-304 as a phase 1 program. Yet, the biotech submitted details of a phase 2b trial of the candidate to ClinicalTrials.gov this week.
The phase 2b is set to start enrolling the first of a targeted 400 patients next month to assess the effect of K-304 on moderate or severe migraine. Kallyope is yet to say anything about the candidate—the name K-304 was only disclosed in the recent pipeline update—but the ClinicalTrials.gov listing gives some key details. Notably, the listing calls the candidate both K-304 and elismetrep.
Mitsubishi Tanabe Pharma finished a phase 2 trial of elismetrep in painful diabetic peripheral neuropathy in 2022. The company then removed the asset from its global pipeline between May 29 and July 25. Elismetrep is an oral inhibitor of TRPM8, a receptor implicated in pain and migraine. A patent for TRPM8 antagonists that was originally assigned to Mitsubishi Tanabe was transferred to Kallyope in August.
Kallyope raised a $236 million series D round three years ago. At the time, Kallyope CEO Jay Galeota said the frosty IPO market had deterred the biotech from tapping public investors for money. Kallyope was planning to go public as soon as the second half of 2022 or as late as the end of 2024. With 2025 well underway, Kallyope has neither gone public nor disclosed another private round.