Pivotal, a European CRO based in Spain, will work with the biotech company Palobiofarma on a Ph II clinical trial for a new oral asthma treatment working on the Adenosine receptor: PBF-680.
A spokesperson from Pivotal told us, the company was selected by Palobiofarma through a bid process to conduct its clinical trial.
The trial will take place over nine sites with 78 patients. It will be a double-blind, randomized, parallel group to test the effects of the drug after 15 days. Results of a Forced Expiratory Volume in one second (FEV1), the primary efficacy variable, will be recorded eight hours post challenge in participants with mild to moderate asthma.
“Pivotal will manage investigational sites through an experienced clinical monitoring team,” said the spokesperson. The company further explained that the trial sites will be contacted frequently to support study performance and visits will be done periodically to ensure proper conduct.
According to the spokesperson, “At the end of the study, all data collected by Pivotal once verified and cleaned, are analyzed by the bio-statistical team to provide tables and analysis in order to generate the final clinical study report.”
The company stated that data management will be performed by Pivotal through a validated Oracle system (Oracle clinical) and statistical analysis will be performed with software as a service (SaaS) technology.
PBF-680 has completed a single dose escalation and treatment period Ph I trial in healthy volunteers as well as, a proof-of-concept Ph IIa trial in individuals with mild to moderate asthma. The Ph IIa trial showed “positive results,” according to the spokesperson.
PBF-680 works as an oral Adenosine A1 receptor antagonist. Adenosine is believed to be an important signaling molecule in Asthma patients. Research has shown that Adenosine has an effect on both bronchoconstrictor responses (the constricting of bronchioles causing limited airflow), as well as airway inflammation.
