- by Alison
Potential dengue treatment on the horizon
Researchers hope that understanding the ‘mechanism of action’ of a well-established HIV treatment could lead to the development of a future dengue cure – easing the burden on millions.
Dengue treatment is often limited to hydration and pain control with symptoms normally last from 2-7 days. But, the impact of the disease can last a lot longer. For families affected by dengue, the financial impact alone can be unbearable. According to the International Federation of the Red Cross, the family’s main provider can lose up to 19 days’ work – and wages – by being incapacitated themselves or caring for sick relatives.
But the family’s income is lost when they need it more than ever. On average, 45 percent of dengue treatment costs are borne by the patient’s family and these can be triple the family’s normal monthly income.
Minimizing the impact of this disease on the world’s most vulnerable communities is one of the top priorities for biopharmaceutical company Ennaid Therapeutics. The company is developing nine novel anti-viral drugs – including one for treating dengue.
Developing a dengue treatment
Founded in 2012, Ennaid identifies early-stage science that could potentially lead to profitable therapeutic cures for previously incurable diseases – mostly neglected tropical diseases (NTDs).
“We seek out early-stage, proprietary, innovative science that’s sitting on research shelves with its patent life ticking away,” comments Darnisha Harrison, Ennaid’s Founder and CEO. “We bring cures to life by taking the science, licensing it and rapidly and safely developing it into therapeutic cures.”
Although Ennaid is currently focused on developing an antiviral to treat Zika Virus, an anti-viral for dengue fever treatment is following a close second on its agenda.
Learn more about measuring the true cost of dengue
Repurposing HIV treatment
Zika and dengue are both envelope viruses, which means they have a protective coating of proteins surrounding them. Darnisha explains how these proteins help an envelope virus to infect its host: “These envelope proteins bind the virus to the healthy host cell in a human’s body. The viruses are then able to release their viral material into the healthy host cell, infecting the cell.”
Dengue belongs to the Flaviviridae family of envelope viruses, which also includes the West Nile virus, yellow fever virus, and Hepatitis C. Another family of envelope viruses, known as Retroviridae, includes HIV and Hepatitis B.
Based on deep understanding of envelope viruses, Ennaid realized it could potentially develop effective and well-tolerated treatments for dengue and Zika. Its knowledge and understanding of a drug that disrupts the HIV virus have enabled it to develop a similar approach for disrupting dengue and Zika.
The drug, which is called enfuvirtide and goes by the brand name of Fuzeon, is a peptide inhibitor: a drug based on a peptide (a short chain of amino acids) that can interfere with a virus’s normal processes. The FDA approved Fuzeon for treating HIV in 2013.
“My discovery scientists at Tulane University had done extensive work with enfuvirtide,” states Darnisha. “With Fuzeon’s clinical success, they concluded peptide inhibitors could be effective and well-tolerated drugs for viral infections.”
Ennaid is now developing a therapeutic treatment for both dengue and Zika by drawing parallels from the success of enfuvirtide. To date, their treatment is undergoing further pre-clinical testing, completing feasibility studies along with safety and toxicity testing.
Tests have shown that the treatment is effective in blocking the dengue virus from entering into the healthy host cell, inhibiting viral infection.
“Our treatment has shown above 99 percent inhibition of the four strains of dengue virus in-vitro and when our peptide was administered to mice, none displayed an increase in toxicity or morbidity above the healthy level,” comments Darnisha.
The results of preclinical efficacy studies are expected within six months. “We are continuing dose range-finding studies in animals and plan to then move into the clinical trials during the first quarter of 2017,” states Darnisha.
Ennaid is also in the final stages of selecting its manufacturing partner for the finished drug product that will be used in clinical trials.
The clinical trials will allow Ennaid to test the safety and efficacy of its treatment in patients who have symptoms of, or who have actually contracted the viruses. Since the timeframe for dengue symptoms is short, the clinical trials should allow Ennaid to establish the efficacy of its dengue drug fairly quickly. Possible locations for these trials will be assessed at a meeting with the FDA – the US Federal Drug Administration. Options might potentially include a trial in the US territory of Puerto Rico alongside a parallel trial in a non-US territory endemic country.
Possible locations for these trials will be assessed at a meeting with the FDA – the US Federal Drug Administration. Options might potentially include a trial in the US territory of Puerto Rico alongside a parallel trial in a non-US territory endemic country.
Pending successful clinical trials, Ennaid will be looking for a buyout by a larger pharmaceutical company to further develop, commercialize and distribute these drugs to the regions of the world that need them most.
Ennaid hopes to get its new treatment to market in around six years rather than the normal 10-15 years since it meets the criteria for FDA’s Priority Review.
New drugs for dealing with neglected tropical diseases such as dengue may fall under what the FDA designates as Priority Review, which means the FDA will aim to act on the drug’s review application within six months. This is compared to ten months under Standard Review.
Darnisha explains more: “With an accelerated review designation, we can possibly provide a clinical protocol that condenses certain phases of the clinical trial. That will help us focus on safety and efficacy while expediting the actual clinical trial.
With clinical trials expected to begin next year, parallels drawn from this HIV treatment could become a source of real hope for a new dengue therapeutic. After all, by slowing disease progression, Ennaid’s treatment would not only reduce the number of cases of severe dengue and hospitalizations; it would also compliment vaccines by slowing the spread of the dengue when patients actually contract the disease.
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