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ADMA Biologics possesses a patent portfolio that targets strep pneumonia and other respiratory pathogens.
900,000 cases annually 40,000 deaths from pneumococcal infections per year within the United States*
In the US, all-cause pneumonia is the #1 cause of vaccine preventable illness and death. Vaccines typically are ineffective in immune compromised patients
*Brooks, L. R. K. & Mias, G. I. Streptococcus pneumoniae's Virulence and Host Immunity: Aging, Diagnostics, and Prevention. Front Immunol 9, 1366, doi:10.3389/fimmu.2018.01366 (2018).
RSV is a common virus that ordinarily leads to mild, cold-like symptoms in healthy adults and children. In high-risk groups, such as the PI population and the other immunocompromised populations, RSV can lead to a more serious infection and may even cause death.
Most recently, data was presented at ID Week in October of 2019 by The Mayo Clinic on 2 cases of RSV patients treated with RI-002.1 In immunocompromised children, RI-002 was used for compassionate treatment in RSV LRTI in stem cell transplant patients. It was concluded that Rl-002 may be useful in the treatment of severe RSV LRTI and may be useful in preventing RSV infection or its progression to severe LRTI.1
We previously conducted a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate RI-001, RI-002’s predecessor product candidate, in immunocompromised, RSV-infected patients. This trial was conducted with 21 patients in the United States, Canada, Australia, and New Zealand. The Phase II dose-ranging trial demonstrated a statistically significant improvement in the change from baseline RSV titers to day 18 in the high-dose and low-dose treatment groups when compared with placebo (P=0.0043 and P=0.0268, respectively). The mean fold increase in anti-RSV neutralizing antibody in the high dose group was 9.24 (95% CI 4.07, 21.02) and the observed mean fold increase in the low dose group was 4.85 (95% CI 2.22, 10.59). The mean fold change for placebo treated patients was 1.42 (95% CI 0.64, 3.17). In addition, more patients in the high dose (85.7%) and low dose (42.9%) groups experienced greater than a 4-fold increase from baseline to day 18 in RSV titer levels compared to placebo (0%). There were no serious drug-related adverse events reported during the trial.2,3
From April 2009 to February 2011, RI-001 was also administered to 15 compassionate use patients where physicians requested access to the product for treating their patients with documented lower respiratory tract RSV infections due to the fact that these patients had failed conventional therapeutic interventions. Serum samples were obtained from 13 patients. Samples showed that patients demonstrated a 4-fold or greater rise in RSV antibody titers from baseline. Serum samples were not obtained from 2 patients that received palivizumab. All patients (11) who received RI-001 within 4.2 days after the onset of the diagnosis of RSV survived.4 The drug was well-tolerated in all 15 patients and there were no reports of serious adverse events attributable to RI-001. Data from our Phase II trial,2,3 compassionate use experience,4 and data obtained from the evaluation of RI-002 in the infected cotton rat animal model5 have been presented at various conferences during 2014, 2015, and 2016. In fact, in 2019 we presented data at ID week on 2 cases of RSV patients treated with RI-002.1 In immunocompromised children, RI-002 demonstrated high levels of neutralizing antibodies to RSV.1
Based on these results, we look forward to working with the FDA and the immunology and infectious disease community on developing a clinical investigation to evaluate use of ASCENIV™ in immune-compromised patients infected with or at-risk for RSV infection.
1. Levy, E. R., et al. (IDWeek 2019 Poster). “Treatment of RSV Lower Respiratory Tract Infection in Two Immunocompromised Children with Polyclonal Immunoglobulin Containing Standardized Levels of Neutralizing Anti-RSV Antibody.”
2. Data on File ADMA Biologics.
3. ADMA Biologics. (2010). RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness. (Clinicaltrials.gov Identifier NCT00632463). Retrieved from https://clinicaltrials.gov/ct2/show/NCT00632463.
4. Falsey, A. R., et al. (2017). "Compassionate use experience with high-titer respiratory syncytial virus (RSV) immunoglobulin in RSV-infected immunocompromised persons." Transpl Infect Dis 19(2).
5. Boukhvalova M, Blanco JC, Falsey AR, Mond J. Treatment with novel RSV Ig RI-002 controls viral replication and reduces pulmonary damage in immunocompromised Sigmodon hispidus. Bone marrow transplantation. 2016;51(1):119-26. Epub 2015/09/15. doi: 10.1038/bmt.2015.212.