AliquantumRx Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the Company a Type B pre-Investigational New Drug (pre-IND) meeting to discuss the development of cethromycin hydrochloride (Cethromycin-HCl) for the treatment of liver-stage malaria.
The FDA meeting is scheduled for March 10, 2026 and follows the Agency’s acknowledgment of AliquantumRx’s pre-IND submission and the opening of a pre-IND file for Cethromycin-HCl. The planned discussion will focus on the Company’s proposed non-clinical, CMC, and clinical strategy supporting first-in-human pharmacokinetic studies and a controlled human malaria infection (CHMI) program targeting liver-stage disease.
“This meeting represents an important regulatory milestone for the Cethromycin-HCl program,” said Nik Kaludov, PhD, President and Co-Founder of AliquantumRx. “We look forward to constructive dialogue with the FDA as we align on the data package required to advance this program into clinical evaluation.”
The Cethromycin-HCl program builds on more than a decade of academic and translational research led by investigators at the Johns Hopkins Malaria Research Institute and is supported by substantial non-dilutive funding for IND-enabling studies and early clinical development.
AliquantumRx is advancing Cethromycin-HCl as a potential short-course, exposure-driven therapy designed to address dormant liver-stage malaria, with the goal of enabling radical cure and primary liver-stage infection.
About AliquantumRx Inc.
AliquantumRx is a near-clinical infectious-disease company developing Cethromycin HCl, a G6PD-independent, short-course therapy designed to eliminate dormant liver-stage malaria and prevent relapse.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, the matters set forth above may be forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, regulatory review outcomes, clinical development timelines, and the ability to generate data supportive of further development. AliquantumRx undertakes no obligation to update such forward-looking statements.