Altavant Sciences presented its patient-centered approach to drug development, which informed the design of an ongoing Phase 2 study, at the Pulmonary Hypertension Association’s recent Annual PH Professional Network (PHPN) Symposium.
The effort was detailed in the poster “A Framework for Engaging PAH Patients in the Drug Development Process” given at the Washington, D.C., meeting.
Altavant is developing rodatristat ethyl (also known as RVT-1201), as a possible therapy for pulmonary arterial hypertension (PAH). Rodatristat ethyl works by lowering the levels of serotonin, a hormone known to send signals that raise blood pressure.
Preliminary studies in healthy volunteers showed a good safety profile.
Altavant recently launched a Phase 2 clinical trial (NCT03924154), called ELEVATE 1, testing rodatristat ethyl in PAH patients. The study is currently enrolling up to 36 patients at sites in the U.S. and Canada; information is available here.
According to the company, patients were at the forefront in developing ELEVATE 1’s protocol.
“We believe that patient involvement in the clinical trial design and implementation process is crucial in the development of new medicines,” William T. Symonds, PharmD, the chief executive officer at Altavant, said in a press release.
This trial design approach includes conducting interviews and surveys to gather information about patients’ actual experiences. It also provides relevant educational content so that patients can make better informed healthcare decisions.
The strategy goes beyond strictly health-related topics, noting the importance of trial participants. Each is sent a thank-you card to participants, and are referred to as “study volunteers” rather than “subjects.”
Altavant also partners with Greater Gift, donating a vaccine to a person in need in honor of each trial participant.
“Published literature suggests that trials designed with patient input enroll faster, potentially lowering development costs,” Symonds said. “In addition, patient feedback is more positive and retention is greater compared to industry standards.
“We look forward to implementing these patient-centric practices across our development programs, and evaluating their impact,” he added.
The company also plans to expand its patient-centered approach by engaging with PAH patients through social media, advisory boards, and advocacy organizations to have their input in future clinical development work.
“A framework for clinical trial patient engagement that takes patient needs and experiences into consideration, and guides interactions may ignite the PAH patient community interest in clinical research, and speed up development of new medicines,” researchers concluded in the poster.
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