In accordance with FDA guidance, 60 Degrees Pharmaceuticals has opted to halt the Phase IIb trial for tafenoquine, known as ACLR8-LR. This surprising decision involves the withdrawal of their Investigational New Drug (IND) application, which was focused on exploring the potential utility of tafenoquine in COVID-19 treatment.
The rationale behind this move stems from recent feedback and recommendations provided by the United States Food and Drug Administration (FDA) concerning necessary adjustments to the trial’s structure. Although this development has momentarily unsettled investor confidence, there are indications suggesting that it could be a strategic decision with long-term benefits in mind.
The US FDA’s feedback has prompted 60 Degrees Pharmaceuticals to reassess the trial design. Rather than viewing this as a setback, the company intends to use this time to carefully evaluate the feasibility of the proposed changes and their implications for assessing the accelerated recovery of COVID-19 symptoms. This approach demonstrates the company’s commitment to conducting thorough and effective clinical trials, even if it means temporarily pausing the process.
Predictably, the announcement of the IND withdrawal resulted in an 11% drop in 60 Degrees’ pre-market stock value. Nevertheless, it’s crucial to emphasize that the company continues to show resilience. Despite the stock drop, 60 Degrees boasts a market capitalization of $6.697 million, signifying its strong presence and potential for growth in the pharmaceutical industry.
A significant advantage of pausing the Phase IIb clinical trial is the potential reduction in operating costs. Implementing this cost-saving measure will enable the company to allocate its resources in a more efficient and strategic manner. In parallel, 60 Degrees Pharmaceuticals is exploring funding options for the trial and considering potential partnerships for tafenoquine’s clinical development, provided market conditions remain favorable and the FDA’s outlook remains positive.
The NCT05947812 study, known as the ACLR8-LR Phase IIb trial, was initially structured to evaluate tafenoquine’s effectiveness in managing mild to moderate COVID-19 symptoms in patients with a low likelihood of disease advancement. Tafenoquine is not a newcomer to the pharmaceutical scene; it gained FDA approval as a prophylactic treatment for malaria in 2018 under the brand name ‘Arakoda.’
In fact, 60 Degrees Pharmaceuticals recently reported a 150% increase in Arakoda sales during the second quarter of 2023 compared to the same period in 2022.
In addition to its ongoing research on COVID-19 and malaria, 60 Degrees is actively exploring the potential of tafenoquine as a treatment for babesiosis, a blood infection transmitted through deer tick bites. The company intends to kickstart discussions with the FDA for a pre-Investigational New Drug (pre-IND) meeting, with the aim of launching a Phase IIb trial in this domain by the close of 2023.
Commenting on the recent developments, 60 Degrees CEO Dr. Geoff Dow stated, “While we determine whether moving forward in modifying ACLR8-LR such that it meets FDA’s requirements is feasible, we will continue existing efforts related to the expansion of our commercial malaria business and submission of an IND for further study of how tafenoquine may be effective in combatting babesiosis.”