“The adjustments we have made to our studies reflect our foremost concern for the safety and well-being of study participants, clinical investigators and their site staffs, our employees and communities as we face this challenging and unpredictable operating environment,” said Warren Huff, Reata’s chief executive officer and president.
Numerous biopharma companies are faced with the difficult decision on whether to continue with clinical trials in light of the ongoing COVID-19 pandemic. Reata Pharmaceuticals, based in Plano, Texas, released an update on its clinical trials and business operations as a result.
After consulting with the trial’s Data Safety Monitoring Board (DSMB), Reata has halted the Phase III CATALYST trial of bardoxolone methyl in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH). These patients have compromised cardiopulmonary function often treated with immunosuppressants, putting them at high risk of infections. Reata decided that it was an unacceptable risk bringing these patients to clinics or in-person visits during the pandemic.
They emphasize there was no drug-related risk seen in the data, which to date has generally been well tolerated. However, although futility analyses haven’t been conducted, an initial review of the efficacy data available suggests the trial is unlikely to meet the primary endpoint. The company indicates it is also closing RANGER, the open-label extension study of bardoxolone in patients with PAH.
The company’s Phase III CARDINAL trial of bardoxolone in patients with chronic kidney disease (CKD) caused by Alport syndrome is completely enrolled and ongoing. The study is continuing. Reata has launched at-home visits to collect blood samples and assess safety as an alternative to in-clinic visits when necessary. It has also set up home delivery of the study drug to the patient. Currently the company doesn’t think the pandemic will have a significant impact on completing the trial or its planned New Drug Application (NDA) for CARDINAL. The patients in CARDINAL are also eligible to enroll in an open-label extension study, EAGLE, which will have similar procedural changes as CARDINAL.
Reata has temporarily paused enrollment of the Phase III FALCON trial of bardoxolone in patients with autosomal dominant polycystic kidney disease (ADPKD). Patients already enrolled will continue. Reata is implementing similar procedures to the CARDINAL trial to ensure safety monitoring and drug delivery. It expects to continue patient screening and enrollment as soon as it can do so safely.
The MOXIe Part 2 trial of omaveloxolone in patients with Friedreich’s ataxia (FA) completed before the COVID-19 pandemic gained momentum. The company doesn’t think the pandemic will significantly impact its planned NDA submission for this indication. Patients in Part 1 or 2 of the study were eligible to take part in an open-label extension. As with the other continuing trials, they are implementing safety and delivery procedures.
As with many biopharma companies, Reata is allowing work-from-home activities and more safety protocols and limiting the number of people working on site. It has also suspended all in-person meetings and international travel and limited domestic travel.
Reata also says its current inventory is sufficient to support the ongoing clinical trials for the year.
“The COVID-19 pandemic presents an unprecedented threat to public health,” said Warren Huff, Reata’s chief executive officer and president, “The adjustments we have made to our studies reflect our foremost concern for the safety and well-being of study participants, clinical investigators and their site staffs, our employees and communities as we face this challenging and unpredictable operating environment. We will continue to monitor and make adjustments, if needed, as we navigate this highly fluid landscape.”
