Still under clinical hold, Fulcrum locks in seasoned commercial leader as CEO

Fulcrum Therapeutics has recruited a new chief executive well versed in the marketing world amid management upheaval, a full clinical hold for its sickle cell program and a Phase III for a different rare disease drug.

Robert Gould

Alex Sapir, who served as CEO at ReViral until Pfizer bought it last April, will replace Robert Gould as Fulcrum CEO on July 1. But that’s not the only change happening at the top: In its quarterly report, Fulcrum also revealed that CFO Esther Rajavelu has resigned, although she will remain in a consulting role.

Gould, a co-founder and former CEO of Fulcrum, stepped up in January to fill the CEO spot after Bryan Stuart departed. Since then, Santiago Arroyo also left after just a few months as chief medical officer.

In a statement, Gould highlighted Sapir’s experience leading companies “through periods of strategic change.” Prior to ReViral, Sapir steered Dova Pharmaceuticals from a small private startup to a public listing — and before that, he held commercial roles at United Therapeutics and GSK, among others.

Before officially assuming the top role, Sapir will work with Gould as a special advisor to the CEO.

Fulcrum is currently enrolling patients into a Phase III trial testing losmapimod for a rare muscle disorder known as facioscapulohumeral muscular dystrophy — and it expects to complete enrollment in the second half of this year.

Sapir will be tasked with overseeing the discussions that Fulcrum is having with the FDA regarding the clinical hold for FTX-6058. The biotech disclosed the hold on its Phase Ib trial in February and has since revealed that it stemmed from “hematological malignancies observed in nonclinical toxicology studies.”

FTX-6058 works by targeting the polycomb repressive complex 2, or PRC2, which is involved in gene expression.

The company noted in an SEC filing that the FDA has requested “information about an SCD patient population with an appropriate benefit-risk profile for further clinical development of FTX-6058” and information “to define the potential risk in any further studies that may be conducted in healthy volunteers.”

Initial data, it added, suggested no serious side effects related to the drug. Meanwhile, one patient saw their fetal hemoglobin increase.

However, the trial has only enrolled six participants so far, and only three were still evaluable at cutoff. Fulcrum implied that compliance challenges could be an issue if and when the trial resumes.

For now, the company is forging ahead. With cash, cash equivalents and marketable securities adding up to $297.8 million — thanks in part to a $117.3 million offering earlier this year — Sapir will have a runway at least into mid-2025.

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