The discontinuation comes after the investigational drug, volenrelaxin, failed a related heart failure study in an overlapping patient population.
Eli Lilly last week terminated a Phase II trial of its investigational relaxin analog volenrelaxin in chronic kidney disease, according to an update to the study’s clinicaltrials.gov webpage.
Lilly is dropping the study because of “a lack of foreseeable clinical benefit” in its target chronic kidney disease (CKD) population. The termination notice also referenced a similarly discontinued “related heart failure study that demonstrated no benefit in an overlapping patient group.” It remains unclear what cardiovascular study this is, though another Phase II trial of the candidate in chronic heart failure with preserved ejection fraction remains tagged as active but is not recruiting.
BioSpace has reached out to Eli Lilly for clarification and will update this space as appropriate.
Volenrelaxin is a synthetic analog of the human relaxin protein that activates the relaxin receptor. Animal studies of the molecule showed that volenrelaxin can elicit relaxin-related pharmacological response, including greater renal blood flow in rats.
A Phase I trial found volenrelaxin to be safe and suitable for subcutaneous dosing, and identified promising signals of efficacy. The synthetic hormone resulted in “sustained improvement in kidney perfusion upon repeated dosing,” according to the study, supporting its further clinical development in chronic kidney disease and chronic heart failure.
Lilly is scheduled to hold its fourth-quarter and full-year earnings call on Feb. 6.
The pharma’s decision to cut volenrelaxin’s mid-stage CKD study has also affected Massachusetts-based Tectonic Therapeutics, whose stock price tanked as much as 40% on Tuesday after the news broke.
Tectonic is advancing TX45, a relaxin fusion molecule that activates the RXFP1 receptor, not unlike volenrelaxin. The biotech is proposing TX45 as a treatment for pulmonary hypertension in the presence of heart failure with preserved ejection fraction.
In a flash note on Tuesday, analysts at Leerink Partners noted that Lilly’s decision to terminate the volenrelaxin study “has caused significant concern about the likelihood of success of TX45.” In a separate follow-up note, however, the Leerink analysts reiterated their confidence in Tectonic, pointing to several key differences between TX45 and volenrelaxin.
TX45, for instance, uses a different relaxin approach than Lilly’s candidate, and is being tested for different indications, according to the Leerink note. Tectonic is also targeting distinct endpoints from Lilly. Tectonic is building toward a Phase Ib readout in the first quarter of 2025.
