Just a bit of info!
$Matinas BioPharma(MTNB.US$ Key Program Updates MAT2203 (Oral Amphotericin B) Program Phase 3 ORALTO Registration Trial ● Matinas reached alignment with the FDA on the design of a single Phase 3 registration trial of oral MAT2203 in patients with invasive aspergillosis who have limited treatment options. This is a serious and life-threatening invasive fungal infection that occurs primarily in severely immunocompromised patients, including those with hematological malignancies and in transplant recipients. In 2022, the World Health Organization released its Fungal Priority Pathogen List that designated the most common invasive aspergillosis, Aspergillus fumigatus, to be in the Critical Priority group, which is designated as the highest perceived public health threat. Aspergillus fumigatus is also included in the FDA qualified designation list of pathogens that pose a serious and life-threatening risk. ● The Phase 3 randomized, multicenter, open-label, adjudicator-blinded ORALTO trial will evaluate the efficacy and safety of MAT2203 as an oral step-down treatment following two days of treatment with AmBisome® (liposomal IV-amphotericin B) compared with the standard of care in patients with invasive aspergillosis who have limited treatment options. The primary efficacy endpoint in this non-inferiority study is all-cause mortality at study day 42. Key secondary objectives include demonstration of superiority for treatment-related toxicities leading to changes in treatment, long-term survival benefit of MAT2203 using all-cause mortality at study day 84 and the impact of MAT2203 on healthcare resource utilization and quality of life. ● The Phase 3 ORALTO trial is expected to include approximately 65 investigator sites in the U.S., Europe, South America, the Middle East and Asia Pacific. Enrollment is expected to include approximately 216 adults with recently diagnosed probable or proven invasive aspergillosis who are being treated with AmBisome due to their inability to receive an IV mold-active azole and with limited alternative treatment options. Following up to two days of treatment with AmBisome, eligible participants will be randomized 2:1 to receive either oral MAT2203 or continued AmBisome treatment followed by standard of care. All study participants will receive up to 12 weeks of treatment starting from the first day of treatment with AmBisome. All study participants are expected to be hospitalized during the initial AmBisome treatment period. After step-down to oral MAT2203, study participants may be discharged to continue treatment on an outpatient basis, as clinically appropriate. An independent Data Review Committee, which will be blinded to treatment, will adjudicate primary and secondary endpoints, including clinical, radiological, and mycological responses. ● Once approximately 75% of participants are enrolled, an independent Data Safety Monitoring Board will review the pooled all-cause mortality rate in a blinded fashion to ensure sample size assumptions are reasonable and the study is adequately powered. Should the pooled event differ substantially from expected levels, a sample size adjustment can be made to the trial. ● The Company is engaged in active dialogues with potential partners and is seeking to finalize a partnership as soon as possible in order to commence the Phase 3 ORALTO trial. MAT2203 Compassionate/Expanded Use Access Program ● A total of 19 patients with serious/life-threatening invasive fungal infections have been enrolled in the program to date, with others being evaluated. The infections treated include a variety of micro-organisms (including Aspergillus, Mucorales species, Candidiasis, Fusarium and suspected Coccidioides) at multiple sites of infection including brain, bladder/colon, bone, lung, sinus, and skin. The majority of enrolled patients are post-transplant or are undergoing treatment for underlying malignancies. ● Patients have been enrolled in the Program at prestigious institutions including the University of Michigan, Johns Hopkins, Nationwide Children’s Hospital, City of Hope, Vanderbilt University Medical Center, the National Institutes of Health, Children’s Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center and the University of California, San Diego School of Medicine. 2 ● Most patients were receiving AmBisome prior to enrollment but developed treatment-limiting nephrotoxicity, and most also required treatment for azole-resistant organisms or had failed azole therapy and had no other treatment options. All patients who transitioned to MAT2203 after developing renal toxicity following treatment with AmBisome experienced a reversal of renal impairment with a return to baseline renal function and no subsequent renal issues. In addition, most patients to date were able to be discharged from the hospital setting and effectively treated at home, supporting the potential significant pharmacoeconomic impact of MAT2203. ● Eight patients who completed the desired course of treatment with oral MAT2203 had complete clinical resolution of their infection and patients with ongoing treatment continue to experience significant clinical improvement
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Jaguar8 : We need this medication. Alert to shorters!
TrytosaveabitOP Jaguar8: Yes sir 100% correct! But you really think that most SS’s give two s*its! As long as they make a few bucks who cares if they have to bankrupt a company doing great things for so many in need! Sad but true my friend
Jaguar8 TrytosaveabitOP: I know and they will suffer the wrath of karma
TrytosaveabitOP Jaguar8: Yup