Clinical Pipeline

60° Pharmaceuticals’ Pipeline of Tropical Disease Medicines

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 tropical diseases. Currently, 60P’s pipeline covers promising clinical development programs for malaria and dengue fever.

 

By leveraging its successful completion of various clinical trials and exclusive research and licensing agreements with the US Army, 60P seeks partnership arrangements for further  advancement and commercialization of its clinical pipeline. Key partnership agreements could support the potential development of new medicines in this important market segment.

Innovation and product development

To innovate new tropical disease treatments, 60P collaborates with other public and private entities to proceed collectively.

60P’s promising dengue fever treatments

60P has two repositioned drugs that have proven safe in human populations for the treatment of dengue fever. 60P has developed a Phase II clinical development campaign for these two candidates:

  • Modipafant: A platelet-activating factor receptor antagonist (60P002)
  • Celgosivir: An alpha-glucosidase I inhibitor (60P001)

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Project/CompoundPotential Indication/ Disease AreaSubmission StatusMilestones
60P001
Alpha-glucosidase I inhibitor
(Celgosivir)
Treatment of dengue fever caused by a dengue virusPhase IB completed

Phase IIA to be initiated


Fulfills the U.S. FDA Priority Review Voucher (PRV) criteria
60P002
Platelet-activating factor receptor antagonist
(Modipafant)
Treatment of dengue fever caused by a dengue virusPhase IIPhase II study to be conducted

Fulfills the U.S. FDA Priority Review Voucher (PRV) criteria

Phases and development stages

Please scroll left and right to see full chart.

PRECLINICAL

PHASE I

PHASE II

PHASE III

MAA IN REVIEW

POTENTIAL AVAILABILITY

ARAKODA® – COVID-19
0%

2021

ARAKODA® – WEEKLY/MONTHLY EX-US MILITARY
0%

2022

ARAKODA® – PREVENTION OF PNEUMOCYSTIS
0%

2024

ARAKODA® – PEDIATRIC MALARIA PREVENTION
0%

2025

CELGOSIVIR – TREATMENT OF ZIKA, SEC. DENGUE & OTHER VIRUSES
0%

2027

MODIPAFANT – TREATMENT OF DENGUE & INFLAMMATORY CONDITIONS
0%

2027

COMPLETED
NEXT PHASE/ONGOING ACTIVITY

CONTINUING TO PURSUE THE FULL PROMISE OF ARAKODA®

Based on interesting preliminary non-clinical and Phase II clinical data, 60P is currently exploring the feasibility of executing development plans for several new indications for ARAKODA® (tafenoquine). It should be noted that ARAKODA has not been approved by any regulator for the interventions described below: 60P’s objective is to generate the clinical data required to potentially allow such approval.

 

Pneumocystis:

In vitro and in vivo studies demonstrate that tafenoquine is effective for treatment and prevention of Pneumocystis at doses in animals that are below the equivalent of doses approved in humans for malaria prevention1,2. Pneumocystis remains an important pathogen in organ transplant patients for whom the current standard of care is sub-optimal in some patient segments3.

 

SARS-CoV-2:

In vitro studies demonstrate that tafenoquine may be active against SARS-Co-V-2 in vitro at concentrations that are potentially achievable following administration of ARAKODA in non-clinical studies (GS Dow, et al, unpublished data, 2020). The current standard of care for out-patient treatment and prevention of COVID 19 is limited to symptomatic relief, quarantine, and social distancing. ARAKODA is not FDA approved for this use. 60P is evaluating conducting future studies to further understand tafenoquine’s utility against this disease.
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Pediatric and Monthly ARAKODA:

Phase II studies have demonstrated that monthly dosing with tafenoquine may be effective4. Additionally, monthly dosing is the standard of care for seasonal malaria prevention in children in Africa. A monthly dosing solution for ARAKODA, if it could be developed, would offer an alternative to the standard of care for malaria prevention in Africa, and make compliance with antimalarial prophylaxis potentially even easier than it is for weekly ARAKODA.

References: 1. Bartlett MS, Queener SF, Tidwell RR, et al. 8-Aminoquinolines from Walter Reed Army Institute for Research for treatment and prophylaxis of Pneumocystis pneumonia in rat models. Antimicrob Agents Chemother. 1991;35(2):277-282. doi:10.1128/aac.35.2.277. 2. Queener SF, Dean RA, Bartlett MS, et al. Efficacy of intermittent dosage of 8-aminoquinolines for therapy or prophylaxis of Pneumocystis pneumonia in rats. J Infect Dis. 1992;165(4):764-768. doi:10.1093/infdis/165.4.764. 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. Walsh DS, Eamsila C, Sasiprapha T, et al. Efficacy of monthly tafenoquine for prophylaxis of Plasmodium vivax and multidrug-resistant P. falciparum malaria. J Infect Dis. 2004;190(8):1456-1463. doi:10.1086/424468
405,000

Annual deaths from malaria globally

125,000,000

Travelers to endemic regions per annum

390,000,000

Dengue infections per year

202-327-5422

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