60 Degrees Pharmaceuticals, Inc. announced that 60P Australia Pty Ltd, a majority-owned subsidiary of 60P, has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19, and intends to submit a new IND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 U.S. Food and Drug Administration (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 (ACLR8-LR), 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.

At estimated 47,000 cases of babesiosis (red blood cell infections caused by deer tick bites) occur in the United States each year, and the incidence is increasing. Babesiosis is endemic in the U.S. Estimates are that 10% of Lyme disease patients are co-infected with babesiosis. Post-exposure prophylaxis following a tick bite is a recognized indication to prevent Lyme disease, and it is likely that a drug proven to be effective for this indication for babesiosis would also be used in conjunction with Lyme prophylaxis.

60P plans to continue its commercialization efforts related to ARAKODA® (tafenoquine), an antimalarial indicated for prophylaxis of malaria in patients 18 years and older and approved by FDA in 2018. In Second Quarter 2023, sales of ARAKODA increased by 150 percent relative to the same period of 2022.