PBF-680 / Palobiofarma, Xoma - LARVOL DELTA

New advances in the treatment of COPD (Navarre Television) - P2a | N=174 | Respire (NCT05262218) | Sponsor: Palobiofarma SL | "Palobiofarma, a Navarrese company with investment from Inveready and SODENA, announced this Monday 'positive' results of a phase 2 trial of the new oral drug PBF-680 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). According to the company, the clinical study 'met its primary endpoint, with PBF-680 10 mg once daily demonstrating a statistically significant reduction in blood eosinophil count (BEC) from baseline to week 4 compared to placebo when added to standard of care'...'We are currently seeking partners to continue the clinical development of PBF-680 towards marketing approval,'..."

P2 data • Chronic Obstructive Pulmonary Disease

PBF-680, an oral A1 adenosine receptor antagonist, increases trough forced expiratory volume in 1 second (FEV1) in mild-to-moderate asthma: a Phase-II trial (ERS 2024) - "A 15-day course of 10-mg PBF-680 increases trough FEV1 in mild-to-moderate asthmatics, with an excellent safety profile. Remarkably, PBF-680 significantly reduces circulating eosinophils. These data support the potential of PBF-680 as a promising oral anti-inflammatory asthma therapy."

P2 data • Asthma • Immunology • Inflammation • Musculoskeletal Pain • Respiratory Diseases

Respire: Therapeutic Effect of PBF-680 in Patients With COPD (clinicaltrials.gov) - P2 | N=174 | Completed | Sponsor: Palobiofarma SL | Active, not recruiting ➔ Completed | N=102 ➔ 174 | Trial completion date: Aug 2024 ➔ Apr 2024

Enrollment change • Trial completion • Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Palobiofarma Secures €7 Million Investment: Paving the Way for Transformative Treatments (BNN Breaking) - "The Spain-based company, specializing in new drug discovery through adenosine receptors modulation, recently announced a €7 million investment round led by Inveready, Sodena, and the company's founders....This significant financial boost will enable Palobiofarma to complete three Phase II clinical trials for their promising products PBF-680, PBF-999...These innovative therapies target chronic obstructive pulmonary disease (COPD), Prader-Willi syndrome...conditions that currently affect millions worldwide....The funds will also support the company's mission to ink new licensing agreements for its advanced-stage assets."

Financing • Chronic Obstructive Pulmonary Disease • Prader–Willi syndrome

Respire: Therapeutic Effect of PBF-680 in Patients With COPD (clinicaltrials.gov) - P2 | N=102 | Active, not recruiting | Sponsor: Palobiofarma SL | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Respire: Therapeutic Effect of PBF-680 in Patients With COPD (clinicaltrials.gov) - P2a | N=102 | Recruiting | Sponsor: Palobiofarma SL

New P2a trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A clinical trial to assess the effect of PBF-680 in patients with moderate to severe Chronic Obstructive Pulmonar Disease on top of standard medication. Ensayo clínico para evaluar el efecto del PBF-680 en pacientes con Enfermedad Pulmonar Obstructiva Crónica de moderada a severa, conjuntamente con la medicación habitual. (clinicaltrialsregister.eu) - P2; N=102; Ongoing; Sponsor: Palobiofarma, S.L

Clinical • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • CRP • TNFA

ADENOASMA: Study to Investigate the Effect of PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Asthmatic Patients (clinicaltrials.gov) - P2; N=107; Completed; Sponsor: Palobiofarma SL; Recruiting ➔ Completed; N=78 ➔ 107; Trial completion date: Feb 2021 ➔ Mar 2020; Trial primary completion date: Dec 2020 ➔ Feb 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Asthma • Respiratory Diseases

[VIRTUAL] PBF-680, an oral A1 adenosine receptor antagonist, inhibits the late allergic response (LAR) in mild-to-moderate atopic asthmatics: a Phase-IIa trial (ERS 2020) - "In mild-to-moderate asthmatics, PBF-680 abrogated the LAR, and reduced the EAR, FeNO, and, remarkably, blood eosinophils, with correct safety profile. The data position the adenosine modulator PBF-680 as a promising oral asthma therapy."

P2a data • Allergy • Asthma • Respiratory Diseases

[VIRTUAL] PBF-680, an oral A1 adenosine receptor antagonist, inhibits adenosine monophosphate (AMP) airway hyperresponsiveness (AHR) in mild-to-moderate asthma: a Phase-IIa proof-of-concept trial (ERS 2020) - "A single 5 or 20-mg PBF-680 dose reduces AMP AHR in mild-to-moderate asthmatics, providing first-time-in-human demonstration of the role of A1 adenosine receptors in bronchoconstriction, and PBF-680 20 mg increases FEV1 at 8h post-dose, with a correct safety profile. Funding: Palobiofarma S.L., Spain"

P2a data • Asthma • Immunology • Pain • Respiratory Diseases

A Study to Assess the Efficacy of a 5-day, 10- mg PBF-680 Oral Administration on Late Asthmatic Responses (LAR) in Mild to Moderate Asthmatic Patients. (clinicaltrials.gov) - P2; N=8; Completed; Sponsor: Palobiofarma SL; Recruiting ➔ Completed; N=16 ➔ 8

Clinical • Enrollment change • Monotherapy • Trial completion • Asthma • Respiratory Diseases

ADENOASMA: Study to Investigate the Effect of PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Asthmatic Patients (clinicaltrials.gov) - P2; N=78; Recruiting; Sponsor: Palobiofarma SL

New P2 trial • Asthma • Biosimilar • Immunology • Respiratory Diseases