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Highlights provide a timely synopsis of selected interesting developments emerging in the past 2 weeks from the information universe covered by the PCORI Health Care Horizon Scanning System (HCHSS). Information covers currently emerging innovations in patient-centered care that may or may not be directly related to the Topics to Watch. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.

With summer ending, the Centers for Disease Control and Prevention reports that new COVID-19 hospitalizations are rising, from 6461 on July 8, 2023, to 15 067 on August 19, 2023. As acute infections increase, so could the importance of investigational therapies such as IMC-2 (valacyclovir plus celecoxib), now under study for post-COVID conditions (PCC, also known as long COVID, see Topics to Watch). Such developer-led research into new PCC treatments might give providers much-needed insight. As the media have reported the National Institutes of Health’s RECOVER research initiative is focused on observational trials to learn about the long-term effects of COVID, and funding is limited for prospective randomized treatment trials that would be expected to elucidate effective treatments. Concerns were raised as early as April 2023.

Developing protections against other respiratory viruses will also be important as cold and flu season arrives. On August 21, 2023, the US Food and Drug Administration (FDA) approved Abrysvo as the first maternal vaccine targeting respiratory syncytial virus (RSV) and intended to prevent severe respiratory infections in infants from birth through 6 months.

In earlier-stage research on maternal-fetal health, developers are testing whether an investigational antibody can prevent a pregnant woman’s immune system from destroying fetal blood platelets and causing severe fetal bleeding (see Topics to Watch).

Another regulatory first occurred August 18, 2023, when the FDA made pozelimab-bbfg (Veopoz) the first approved therapy for treating CHAPLE disease (CD55-deficient protein-losing enteropathy), an ultrarare, potentially fatal autoimmune disease affecting children and adults.

Topics to Watch

ECRI Horizon Scanning has selected the topics below as those with potential for impact within the PCORI HCHSS’s focus areas in the United States within the next 3 years. All views presented are preliminary and based on readily available information at the time of writing. Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.

IMC-2 (Valacyclovir plus Celecoxib) to Treat Post-COVID Conditions

At a Glance

  • Estimates suggest as many as one-third of patients develop post-COVID conditions, or PCC, after acute SARS-CoV-2 infection. About 6% of adults in the United States report they are currently experiencing PCC.
  • No drugs are US Food and Drug Administration-approved for the treatment of PCC. Current care focuses on symptom management. A major unmet medical need remains for safe, effective treatments targeting underlying causes of PCC.
  • IMC-2 is an investigational treatment for PCC, consisting of valacyclovir and celecoxib, both drugs approved individually for other indications. According to the manufacturer, IMC-2 is designed to treat PCC by inhibiting viral replication and the reactivation of SARS-CoV-2 and other latent infections.
  • One open-label, proof-of-concept study in women with PCC suggested that IMC-2 treatment alleviated common PCC symptoms of fatigue and orthostatic symptoms (eg, lightheadedness, dizziness).
  • Based on these data, the developer announced plans to initiate a double-blind, placebo-controlled study.

For a description and commentary about this topic/issue, download this Innovation Brief.

RLYB212 to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia

At a Glance

  • Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a rare immune disorder that can develop in pregnant women and cause loss of fetal blood platelets.
  • FNAIT increases the risk of severe bleeding in a fetus or newborn, potentially leading to miscarriage, neonatal death, or development of permanent disability.
  • No US Food and Drug Administration-approved measures are available to prevent FNAIT. Treatment usually involves blood transfusions to replace lost platelets in newborns, often after severe bleeding has already occurred.
  • RLYB212 is an experimental monoclonal antibody therapy designed to prevent maternal immune recognition of fetal platelets as foreign, thereby blocking the underlying cause of FNAIT.
  • Based on a promising proof-of-concept demonstration of safety and efficacy in healthy volunteers, the developer plans a 2024 study to evaluate RLYB212 in pregnant women at increased risk of FNAIT.

For a description and commentary about this topic/issue, download this Innovation Brief.

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Posted: September 14, 2023

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