Positive Data from the CARE CF 1 Clinical Study of Oral Lynovex in Cystic Fibrosis Exacerbations

NovaBiotics Ltd (“NovaBiotics”) announces that its oral therapy for cystic fibrosis (CF), Lynovex®, has met the study objectives of the CARE CF 1 clinical trial.

CARE CF 1 assessed the effects of two weeks of Lynovex treatment as an adjunct to standard of care therapy (SOCT) in CF, compared to placebo plus SOCT. This trial was designed to determine whether the inclusion of Lynovex capsules alongside SOCT lessened the clinical impact of exacerbations in adults with CF, as measured by symptom severity and levels of bacteria and inflammatory mediators in sputum and blood.  CARE CF 1 was a 6-arm study with the primary objectives of determining the optimal dose and regimen of Lynovex in patients with exacerbations of CF-associated lung disease and to further evaluate the safety and tolerability of Lynovex in exacerbating CF patients.  Continue reading Positive Data from the CARE CF 1 Clinical Study of Oral Lynovex in Cystic Fibrosis Exacerbations

Potential Therapy for Infections in CF Gets Patent

AB569Arch Biopartners’ treatment candidate for bacterial infections in patients with cystic fibrosis, chronic obstructive pulmonary disease (COPD), and other respiratory conditions, has received a U.S. patent.

The U.S. Patent and Trademark Office issued patent 9,925,206 to the University of Cincinnati, which granted Arch Biopartners an exclusive commercial license on all patents related to AB569. The inventor is Daniel Hassett, PhD, a principal scientist at Arch and professor at the University of Cincinnati College Of Medicine.

“This patent issuance, which protects the composition of AB569, gives Arch a stronger commercial position to pursue treating not just CF patients, but also the millions of other patients that have chronic antibiotic resistant lung infections including those with COPD,” Richard Muruve, CEO of Arch, said in a press release. “It also opens the door for Arch to develop treatments for many other indications where antibiotic resistance is a problem, such as urinary tract infections and wound care.”

Bacterial infections in the lungs are a serious problem in patients with CF, COPD, or ventilator-associated pneumonia. Cystic fibrosis patients are susceptible to bacterial respiratory infections as a result of abnormal mucus production in the lungs and airways.

In particular, the bacterium Pseudomonas aeruginosa (P. aeruginosa) affects most adult CF patients and 40 percent of CF children ages 6 to 10. The mucoid form of P. aeruginosa is highly resistant to conventional antibiotics and immune-mediated killing. It causes a rapid decline in lung function and a poor overall clinical prognosis.

Antibiotic use in the treatment of CF and COPD patients with chronic bacterial respiratory infections is increasing, which correlates with a higher prevalence of antibiotic-resistant strains.

AB569 is a non-antibiotic therapy made of sodium nitrite and ethylenediaminetetraacetic acid (EDTA), two compounds approved by the U.S. Food and Drug Administration (FDA) for human use. The treatment has a different mechanism of action from antibiotics that may increase effectiveness, Arch believes.

“AB569 has two active ingredients that produce a dramatic and synergistic effect at killing many antibiotic resistant bacteria including Pseudomonas aeruginosa (P. aeruginosa), which commonly causes severe chronic infections in the lungs of cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) patients,” Hassett said. “AB569 has the potential to make a significant medical impact on treating infection where traditional antibiotics fail.”

In preclinical experiments, the therapy showed significant ability to kill several types of Gram-negative and Gram-positive bacteria.

The safety and pharmacokinetics of a single administration of nebulized AB569 are now being evaluated in a Phase 1 clinical trial with up to 25 healthy volunteers at the Cincinnati Veterans Affairs Medical Center (CVAMC). Pharmacokinetics refers to how a drug is absorbed, distributed, metabolized, and expelled by the body. Enrollment of volunteers started in February.

If the Phase 1 study provides positive results, the company plans to start a Phase 2 trial to test the effectiveness of AB569 in the treatment of chronic lung infections caused by P. aeruginosa and other bacterial pathogens in CF and/or COPD patients.

AB569 previously received orphan drug status from the FDA for the treatment of CF patients infected with P. aeruginosa, and orphan medicinal product designation from the European Medicines Agency.

For original article, click here.

Phase 1b Trial of QR-010

https://globenewswire.com/news-release/2017/08/29/1101646/0/en/ProQR-Completes-Dosing-of-Cystic-Fibrosis-Patients-in-QR-010-Phase-1b-Trial.html

ProQR Completes Dosing of Cystic Fibrosis Patients in QR-010 Phase 1b Trial

Key Updates
• Last patient received their final dose in the PQ-010-001 Phase 1b clinical trial of QR-010 in CF patients with the F508del mutation.
Top-line trial data are expected to be issued in a press release Continue reading Phase 1b Trial of QR-010