60 Degrees Pharmaceuticals Inc’s SXTP subsidiary, 60P Australia Pty Ltd, has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase 2B study of the use of tafenoquine in treating COVID-19.
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 the FDA in the fourth quarter, 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 the FDA, 60P has paused further start-up activities for its Phase 2B trial (ACLR8-LR), decreasing the company’s burn rate and improving its cash position in the short term.
Should the outcome of further interactions with the FDA be positive, and depending on market conditions, the company will decide whether to continue its original strategy of self-funding its Phase 2B study or seek a strategic partner to continue development.
In parallel, 60P plans to continue preparing a Phase 2A study of tafenoquine in hospitalized babesiosis patients to request a pre-IND meeting with the FDA before the end of 2023.
60P plans to continue its commercialization efforts related to Arakoda (tafenoquine), an antimalarial for prophylaxis of malaria in adult patients, approved by the FDA in 2018. In Q2 2023, sales of Arakoda increased by 150% Y/Y.
Price Action: SXTP shares are down 28.1% at $0.83 during the premarket session on the last check Tuesday.