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One of the few drugs available to treat mpox is Setbacks This comes at a time when a new, potentially more deadly, disease outbreak is gaining momentum.
Shiga Technologies recently reported that its antiviral drug Tpoxx did not cure the disease’s characteristic blistering rash any faster than a placebo in a government-backed clinical trial. The announcement sent the company’s stock price soaring. Tumbling.
Tpoxx is the industry-leading antiviral drug against MPOX and is widely used by physicians worldwide. 2022 outbreak It is caused by the milder strain 2 of the virus. The European Medicines Agency has approved the drug to treat measles, smallpox, cowpox, and vaccinia, but in the United States, Tpoxx is only indicated for smallpox, and patients Expanded or compassionate use or through NIH-sponsored trials.
The latest clinical trial data on Tpoxx comes from a study in the Democratic Republic of Congo, which shows that the drug is safe but does not appear to speed recovery in lineage 1 mpox patients.
“Although these results are disappointing, they provide important information and reinforce the need to identify other potential treatments for MPOX as well as continue studying the use of tecovirimat in other patient populations with MPOX,” said NIAID Director Jeanne Marrazzo, PhD. Written Release.
But Dr. Jay Varma, chief medical officer at Sigma, said the discouraging data doesn’t suggest the drug doesn’t work, but rather that the choice of endpoints was flawed. Because the study was part of a compassionate response, about 20% to 30% of trial participants received the drug beyond the seven-day period when it works best, Dr. Varma said.
“We believe Tpoxx will have the greatest utility as a post-exposure prophylaxis.”
Dr. Jay Varma
Chief Medical Officer, SIG Therapeutics
“Extensive animal studies have shown that this drug, if administered early in the treatment process, is likely to be highly effective in preventing the development of severe MPOX disease in patients and speeding up healing times,” Varma said.
Severely ill trial participants who took the drug within seven days of the onset of symptoms saw significant improvements.
“While further analysis is required, we believe these data support further trials to evaluate the potential benefit of Tecovirimat in people who seek medical care soon after the onset of symptoms and in those with severe disease,” the company said. press release.
Additionally, the placebo group in the study may have performed better than expected, which could have clouded the results. All patients who took the placebo were hospitalized and received supportive care, which may have reduced the mortality rate in both groups. The mortality rate for study participants was 1.7% vs. 3.6% Of all the cases in the Democratic Republic of Congo.
A growing threat
Still, the timing of this failure is not ideal. The World Health Organization recently sounded the alarm about the latest outbreak and recommended MPOX Public Health Emergency of International Concern Call for a coordinated multilateral response. The outbreak began in the Democratic Republic of the Congo, where a new, potentially more virulent lineage of sexually transmitted MPOX, lineage 1b, emerged in 2023.
So far in 2024, the Democratic Republic of Congo has recorded 15,600 cases and 537 deaths from MPOX, exceeding last year’s totals, according to the WHO. Experts fear the outbreak may be driven by a rise in infections among sex workers, migrant truck drivers and miners in the Democratic Republic of Congo, Varma said. But children are at higher risk. Democratic Republic of Congo reports half of cases and 463 deathsUNICEF reported that several other African countries, and more recently, Sweden Cases have also been reported.
Varma said the outbreak is expected to spread around the world, including in the U.S. But the good news is health officials can deploy the same strategies they’ve always used.
“This is not COVID,” he said.
Responders already know how to contain MPOX using existing diagnostic tests, medications, and two approved vaccines.
The first choice is Jynneos injection, manufactured by Bayer Nordic. The second is ACAM2000, a smallpox vaccine. Expanded Access Investigational Drugs Protocol. Vaccines, if administered at the appropriate time, can also prevent known post-exposure diseases such as Tpoxx, or other less common Antiviral drugsVarma said doctors are called in when people fall ill because they haven’t been vaccinated or have contracted a sudden infection.
“Ultimately, we think Tpoxx will have the greatest utility as a post-exposure prophylaxis,” he said.
Varma said the company hopes to gain broader approval for Tpoxx over mpox, but to achieve that, efficacy data is needed, and the company hopes to collect that data through additional trials, including four already underway in the U.S. and other countries. All four studies are being conducted by independent researchers and are currently enrolling patients. Siga doesn’t yet know when new data on the drug will be released.
“We continue to support trial sponsors and enrollment activities to advance these studies as quickly as possible to gain a deeper understanding of the potential for Tpoxx to benefit patients with mitochondrial cystitis,” the company said in an emailed statement.
Still, Varma is cautiously optimistic that the U.S. has what it takes to take on MPOX.
“If it spreads in the U.S., there will be cases and suffering, but we expect it won’t be on the scale of the 2022 epidemic because lessons have been learned and awareness has increased,” Varma said. “But we really don’t know. The virus is always evolving and could surprise us.”
