60° Pharmaceuticals’ Pipeline of Infectious Disease Medicines & Indications

60° Pharmaceuticals (60P)—a growth-oriented specialty pharmaceutical company—is putting cutting-edge biological science and applied research to use in furthering therapies for the prevention and treatment of infectious diseases. Currently 60P’s pipeline covers promising clinical development programs for COVID-19, babesiosis, dengue and other viral illnesses.

ARAKODA

Fulfilling the Promise of ARAKODA

By leveraging its successful completion of clinical development and FDA approval of ARAKODA^® (tafenoquine) for malaria prevention and exclusive research and licensing agreements with the U. S. Army, and with promising new non-clinical and clinical data in hand, 60P is seeking to expand the list of indicated uses for its already approved product, ARAKODA.

COVID-19 therapeutic treatment

ARAKODA^® (tafenoquine) has exhibited positive Phase II study data in patients with mild-moderate COVID-19 disease.* Trial data has been published in New Microbes and New Infections, a peer-reviewed, open-access journal.

• The study evaluated the safety and efficacy of tafenoquine in patients with mild-moderate COVID-19 disease
• Larger studies are planned to evaluate tafenoquine efficacy in treating COVID-19
  

Treatment of Babesiosis

Tafenoquine exhibits useful activity in animal models of babesiosis and according to case reports may have clinical utility in treatment of drug-resistant strains.*

• In collaboration with leading U.S. institutions, 60P is planning a proof of concept clinical study to assess the utility of ARAKODA as a treatment for human babesiosis.

Treatment & Prevention of Fungal Diseases

In vitro and in vivo studies demonstrate that tafenoquine is effective for treatment and prevention of fungi such as Pneumocystis and yeasts at concentrations/doses that are clinically relevant.^1,2* Pneumocystis remains an important pathogen in organ transplant patients for whom the current standard of care is sub-optimal in some patient segments.³ Many infections caused by yeasts such as Candida auris are refractory to standard of care medications such as azoles, amphotericin B, and echinocandins.²

60P’s CELGOSIVIR

60P is planning a clinical development campaign for the repositioning of celgosivir, a host-targeted glucosidase inhibitor that was developed separately by other sponsors for HIV and then for hepatitis C.⁴ Similar to other dengue antivirals, celgosivir has shown diminished activity in curing dengue infections in animal models when administered after animals become symptomatic. However, in clinical trials, this issue was addressed by administering the same drug dose split into four doses per day, rather than one or two doses per day.⁵

• Continued development of repositioned molecules to combat dengue fever, solely and in isolation
• Preliminary data suggest celgosivir may inhibit the replication of the virus that causes COVID-19 (Sars-CoV-2) in cell culture, the RSV virus in cell culture, and may protect the lungs from RSV infection in animals*
• The U.S. Food and Drug Administration has yet to review the safety and efficacy of celgosivir for treatment of dengue fever*

Phases and development stages

*ARAKODA has not been reviewed or approved by the U.S. Food and Drug Administration for the treatment or prevention of COVID-19, babesiosis, or fungal diseases.
^†ARAKODA is commercially available in the U.S. for malaria prevention and will be the subject of only targeted marketing efforts in 2023 as resources permit. An aggressive U.S. marketing campaign for malaria prevention may be undertaken in 2024 but will require a second capital raise to support it.
^‡This study will evaluate the dose of ARAKODA that is FDA-approved and commercially available in the U.S. for malaria prevention. The indicated study is planned. It is not known whether an additional clinical study would be required for regulatory approval. The Company will conduct planning activities for a second COVID-19 study in case this is required, but a second round of financing would be required to support its execution. An optional futility analysis at 33% enrolment will be included in the protocol. An interim analysis at 75% enrolment will be included in the study.
^§Preparatory activities including protocol preparation and IND submission will be covered under the proposed offering. Execution of the treatment study will require additional funds.
^||Both these products have been the subject of at least Phase II clinical studies for other indications. Additional non-clinical efficacy and mechanism of action studies are required before committing to further clinical development. These activities will be conducted in 2023 only if resources permit.

References: 1. Dow GS, Smith BL. Tafenoquine exhibits broad spectrum antifungal activity at clinically relevant concentrations in vitro and decreases lung fungal burden in an invasive pulmonary model of Rhizopus in vivo. New Microbe New Infect 2022; 45: 100964. 2. Garcia-Bustos V, Cabanero-Navalon MD, Ruiz-Sari A, Ruiz-Gaitan AC, Salavert M, et al. What do we know about Candida auris? Microorganisms 2021;9:1–20. 3. Fishman JA, Gans H; AST Infectious Diseases Community of Practice. Pneumocystis jiroveci in solid organ transplantation: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13587. doi:10.1111/ctr.13587. 4. Sorbera LA, Castaner J, Garcia-Capdevila L. Celgosivir. Drugs Fut. 2005, 30(6): 545. doi: 10.1358/dof.2005.030.06.914820. 5. Watanabe S, et al. Optimizing celgosivir therapy in mouse models of dengue virus infection of serotypes 1 and 2: The search for a window for potential therapeutic efficacy. Antiviral Res. 2016 Mar;127:10-9. doi: 10.1016/j.antiviral.2015.12.008.