Miltefosine

Patent provides exclusive use through 2040 of tafenoquine for treatment of COVID-19 and other lung infections. Tafenoquine is the active molecule in 60P’s FDA-approved drug for malaria prevention, ARAKODA®. Data from a Phase II study completed last year suggest a positive therapeutic signal in mild-moderate COVID-19 disease using the ARAKODA regimen of tafenoquine. Later this year the Company will launch a Phase IIB study enrolling COVID-19 patients in 30 U.S. outpatient clinics. 60P expects Phase IIB study will demonstrate ARAKODA regimen of tafenoquine accelerates time to sustained clinical recovery from COVID-19 symptoms. WASHINGTON, April 26, 2023 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals (“60P”), specialists in developing and marketing medicines for infectious diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the use of tafenoquine as a treatment for COVID-19 disease. Tafenoquine is the active molecule in the Company’s FDA-approved regimen for malaria prevention, ARAKODA®. 60P now owns the exclusive rights for the use of tafenoquine for treatment of viral lung infections including COVID-19 in the U.S. through 2040. ARAKODA, an oral tablet containing 100 mg of a tafenoquine base, is indicated for the prophylaxis of malaria in patients aged 18 years and older for up to 6 months of continuous dosing in the U.S. ARAKODA is not currently FDA-approved for the treatment of symptoms caused by the COVID-19 virus. 60P plans to conduct a double-blind, randomized, placebo-controlled Phase IIB trial to study the efficacy of the ARAKODA regimen of tafenoquine in COVID-19 patients with mild-moderate symptoms and low risk of disease progression. The primary endpoint of the Phase IIB study will be time to sustained clinical recovery from COVID-19 symptoms. The study will enroll patients in 30 out-patient clinics across the U.S. The Company is also planning a larger study that will commence in 2024. Data from a Phase II study published in New Microbes and New Infections, Vol. 47, April – May 2022, a peer-reviewed, open-access journal, suggested a positive therapeutic signal in mild-moderate COVID-19 disease using the ARAKODA regimen of tafenoquine; the time to clinical recovery from COVID-19 symptoms was accelerated by about 2 – 2.5 days in the tafenoquine arm. Public health interest in combating COVID-19 remains high. Currently marketed FDA-approved oral COVID-19 therapeutics are not appropriate for use by at least 25 percent of the U.S. population who do not have risk factors for progression to severe disease or by travelers who may wish to protect themselves from COVID-19 for extended periods – an unaddressed multi-billion-dollar market opportunity. 60P is optimistic that the ARAKODA regimen of tafenoquine will play an important role in public health efforts to address gaps in the standard of care for COVID-19. About the ARAKODA® Regimen of Tafenoquine for COVID-19 Clinical trial data suggesting the ARAKODA® regimen of tafenoquine exhibits a positive therapeutic signal in mild-moderate COVID-19 disease were published last year in New Microbes and New Infections, Vol. 47, April – May 2022, a peer-reviewed, open-access journal. The drug increased the proportion of clinically recovered patients by between 9 percent (intent to treat population) and 14 percent (per protocol population); the drug decreased the proportion of clinically unrecovered patients by between 27 percent (intent to treat population) and 47 percent (per protocol population) but was underpowered to show statistical significance for the primary endpoint due to early termination of the study at n=86 patients. Results also showed that time to clinical recovery from COVID-19 symptoms was accelerated by about 2 – 2.5 days in the tafenoquine arm of the double-blind, randomized, placebo-controlled Phase II study. About ARAKODA® (tafenoquine) Tafenoquine was discovered by Walter Reed Army Institute of Research and the current study was funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. It has been shown that tafenoquine inhibits SARS-CoV-2 replication in monkey kidney and human epithelial cells, and pharmacokinetic simulations suggest lung levels at the FDA-approved dose for malaria prevention may exceed the EC90 of the drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA is not suitable for everyone and patients and prescribers should review the Important Safety Information below. ARAKODA® (tafenoquine) Important Safety Information ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. Important Safety Information Contraindications ARAKODA should not be administered to: Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown Patients with a history of psychotic disorders or current psychotic symptoms Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA Warnings and Precautions Warnings and Precautions Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. G6PD Deficiency in Pregnancy or Lactation:ARAKODA may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA through breast milk. Check infant’s G6PD status before breastfeeding begins. Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA therapy and evaluation by a mental health professional as soon as possible. Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA. If hypersensitivity reactions occur, institute appropriate therapy. Delayed Adverse Reactions: Due to the long half-life of ARAKODA, (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration. Adverse Reactions The most common adverse reactions (incidence ≥1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety. Drug Interactions Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters. Use in Specific Populations Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or ARAKODA full prescribing information is here. About 60 Degree Pharmaceuticals, Inc. 60 Degrees Pharmaceuticals, Inc., founded in 2010, focuses on discovering, developing and distributing new medicines for the treatment and prevention of tropical diseases, including malaria and dengue. 60P’s mission is supported through in-kind funding from the United States Department of Defense. The Company also collaborates with prominent research organizations in the U.S., Australia and Singapore. In addition, 60P has been funded by Knight Therapeutics Inc., a Canadian specialty pharmaceutical company that obtained FDA approval for Impavido, a product for leishmaniasis, a tropical disease, and monetized a PRV. 60P is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at . Forward-Looking Statements The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. The statements expressed herein are those of 60P and do not necessarily represent those of the United States Department of Defense or the Department of the United States Army. Forward-looking terminology, such as “may,” “will,” “should,” “expect,” “anticipate,” “project,” “estimate,” “intend,” “continue” or “believe” or the negatives thereof, or other variations thereon or comparable terminology, may discuss our plans, strategies, prospects and expectations concerning our business, operating results, financial condition and other similar matters. However, we are not able to predict accurately or control these matters. Any forward-looking statement made by us in this press release speaks only as of the date on which we make it. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Media Contact: Sheila A. Burke Method Health Communications methodhealthcomms@gmail.com 484-667-6330

Researchers are a step closer to identifying ways to support clinicians in predicting drug treatment outcomes for patients with visceral leishmaniasis in Brazil. Researchers at the University of York are a step closer to identifying ways to support clinicians in predicting drug treatment outcomes for patients with visceral leishmaniasis in Brazil. Scientists at York had previously shown that the absence of four particular genes in some strains of Leishmania infantum parasite found in Brazil makes it less susceptible to an oral drug called miltefosine. The absence of these genes correlates with resistance to the drug, which means that Brazilian patients would benefit from a prognostic test, but in order to do this scientists first had to identify what it was about the gene that made the parasite drug-resistant. During a clinical trial using miltefosine treatment, 40% of patients relapsed within six months, but the presence of the genes in the parasite found in India, however, meant that after a month of treatment, the disease could be cured with a lower risk of relapse. As a result of its 'failure' in Brazil the medication is not licensed in the country and therefore there is very little that can be done to manage the disease in patients, other than intravenous drugs which can prove to be a burden on medical facilities who have to deliver it. The team, in collaboration with colleagues from the Universidade Federal do Piauí and and the Universidade Federal do Espírito Santo, have now taken the work a step further and identified the enzymes that make the difference between treatment success and failure. Juliana Brambilla Carnielli, Research Associate at the University of York's Department of Biology, said: "Now that we have narrowed the search from a set of genes to an enzyme, the potential for developing a blood test that can accurately predict patient outcome is more likely. "There is no one-size-fits all treatment, and so a personalised medicines approach is needed, whereby a prognostic test to predict treatment success at an individual level can be provided. "This disease impacts people in India, Brazil, Africa and some parts of Europe, so it really is important that we understand more about how the parasite lives in humans and reacts to drugs." Leishmaniasis is a parasitic disease transmitted to humans by the bite of the infected female sandfly. With 50,000 to 90,000 new cases worldwide each year, it causes fever, substantial weight loss, swelling of the spleen and liver and anemia and can be fatal if left untreated. The parasite first arrived in South America from Europe in the 1600s and has changed and adapted over time, Jeremy Mottram, Professor of Pathogen Biology and Director of the York Biomedical Research Institute, said: "This latest finding means that we are much closer to moving to clinical trials on patients in Brazil and to understand whether prognostic tests early in the disease progression and tailored medicines could reduce the numbers of patients relapsing with the disease." Up to 2,500 patients presented with the condition in Brazil in 2019 with a lethality rate of 9%, the highest recorded over the last 10 years, creating a significant burden on hospital resources. The research is funded by an MRC GCRF Foundation Award, MRC GCRF 'A Global Network for Neglected Tropical Diseases', and the Fundação de Pesquisa do Estado do Espírito Santo -- FAPES, Brazil, and is published in the journal eBioMedicine.