Aridis to Start Phase 1/2a Trial for Inhalable Antibacterial Therapy AR-501 in CF Patients
Aridis Pharmaceuticals is planning to launch a Phase 1/2a clinical trial in the beginning of 2019 to evaluate the potential of its investigational antibacterial compound AR-501 (gallium citrate) in patients with cystic fibrosis (CF).
This follows the approval of the Investigational New Drug application for AR-501 by the U.S. Food and Drug Administration (FDA).
The FDA has also granted Fast Track Designation and Qualified Infectious Disease Product Designation (QIDP) to AR-501. These are expected to support and expedite the therapy’s development and regulatory review.
“The Fast Track and QIDP product designations provide us the means to accelerate clinical development of AR-501 and could enable us to bring this innovative drug candidate to the CF patient population more quickly,” Vu Truong, PhD, CEO of Aridis Pharmaceuticals, said in a press release.
AR-501 is an inhaled form of gallium being developed to treat pulmonary bacterial infections. It works by starving bacteria of iron and inhibiting the iron-dependent metabolic processes necessary for the infection to progress, a mechanism very different from that of common antibiotics.
According to the company, AR-501 has been shown to have broad antibacterial activity with unique benefits compared to current standard-of-care antibiotics, working against antibiotic-resistant strains such as Pseudomonas aeruginosa and B. cepacia.
Results from a previous Phase 2 clinical trial (NCT02354859) demonstrated the safety and efficacy of intravenous gallium to improve lung function in CF patients.
“AR-501 has the potential to offer patients more convenient dosing (once per week) versus standard- of-care inhaled antibiotics (several times per day),” and with a “more effective delivery route than (IV) administered gallium,” Truong said.
In addition, it is a broad-spectrum antimicrobial agent “with a low propensity for developing drug resistance,” he said.
The new Phase 1/2a trial will be conducted with the support of the Cystic Fibrosis Foundation (CFF).
The CFF has increased the value of the grant previously agreed to with Aridis to up to $7.5 million, contingent on the achievement of AR-501 development milestones, the company announced.
“The additional funding will expedite clinical development and demonstrates the CF Foundation’s continued support for the clinical development of AR-501,” Truong said.