60 Degrees Pharmaceuticals withdraws ACLR8-LR IND application

60 Degrees Pharmaceuticals announced that 60P Australia, a majority-owned subsidiary of 60P, has withdrawn its investigational new drug, or IND, application for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19, and intends to submit a new IND in the fourth quarter. The company’s decision to withdraw the IND is in response to recent comments from the FDA. 60P plans to submit a new IND to FDA within the current year, pending an assessment of whether it is feasible to revise the trial design to meet the agency’s expectations while also allowing for confirmation of the acceleration in recovery from COVID-19 symptoms suggested by an earlier study. In the interim, pending additional interaction with FDA, 60P has paused further start-up activities for its Phase IIB trial, thereby decreasing the company’s burn rate and improving its cash position in the short term. Should the outcome of further interactions with FDA be positive, and depending on market conditions, the company will make a decision regarding whether to continue its original strategy of self-funding its Phase IIB study or to seek a strategic partner to continue development. In parallel, as outlined in its registration statement and subsequent communications to the investment community, 60P plans to continue preparation of a Phase IIA study of tafenoquine in hospitalized babesiosis patients, with the goal of requesting a pre-IND meeting with FDA before the end of the calendar year. 60P plans to continue its commercialization efforts related to Arakoda, an antimalarial indicated for prophylaxis of malaria in patients 18 years and older and approved by FDA in 2018.