Clinical Trials

Date: 2013-05-20

Type of information: Results

phase: 1

Announcement: results

Company: Destiny Pharma (UK)

Product: XF-73 - exeporfinium chloride

Action mechanism:

• XF-73 is a novel dicationic porphyrin with rapid bactericidal activity against Gram-positive bacteria including Staphylococcus aureus (methicillin sensitive and multi-drug resistant strains including MRSA). XF-73 was developed by Destiny Pharma, Ltd., a pharmaceutical company based in Brighton, United Kingdom. Previously, it was tested in three early-stage trials in Europe and showed promising safety, tolerability and efficacy results.

Disease: Staphylococcus aureus

Therapeutic area: Infectious diseases

Country: USA

Trial details:

• This Phase I, single-center, clinical study of XF-73 evaluates the local (nasal) safety and tolerability of a modified, thinner lower viscosity formulation of intranasal XF-73 in healthy male and female subjects. In addition, the potential for systemic absorption of XF-73 in the modified, thinner lower viscosity and the previously investigated thicker, higher viscosity formulations and their decolonization efficacy in comparison to placebo will be evaluated. Both parts of the study will be double-blinded and Part 2 will also be placebo-controlled.
• The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, and was conducted at the NIAID Clinical Trials Unit at Case Western Reserve University in Cleveland and at Anaheim Clinical Trials in California. (NCT01592214)

Latest news:

• •On September 5, 2016, Destiny Pharma announced the results of a US clinical trial of the novel preventive anti-bacterial drug exeporfinium chloride (XF-73). The two-stage clinical trial studied the safety, tolerability, and efficacy of intra-nasally applied exeporfinium chloride gels. Part 1 yielded safety data in eight volunteers and allowed progression to Part 2 in 48 healthy volunteers with colonized nasal Staphylococcus aureus (SA) bacteria. Part 2 was double-blinded, placebo controlled, and investigated two exeporfinium chloride concentration gels (0.5 & 2.0mg/g) and two viscosities (2 and 4 percent) applied into the nostrils for 5 days. Both concentrations were deemed safe and well-tolerated, and no drug was detected in the bloodstream. There was a similar safety profile observed in exeporfinium chloride and placebo-treated subjects, which is important because the product will be used in a preventive manner. In general, exeporfinium chloride demonstrated a rapid, anti-staphylococcal effect after 1 day, with the 2.0mg/g gel showing a statistical difference against placebo, which was sustained throughout dosing.• On May 20, 2013,  Destiny Pharma has announced the further progression of the Phase I US clinical trial of its lead drug XF-73 to Part 2 of the trial. Part 1 investigated XF-73\'s safety, tolerability and distribution, while the forthcoming Part 2 will additionally investigate the efficacy of the drug for nasal decolonization of Staphylococcus aureus (SA) in modified gel formulations when applied for several days under conditions akin to those experienced in hospitals. The clinical trial is studying Staphylococcus aureus (SA) decolonization (i.e. the clearance of SA from the nostrils of carriers) as well as safety and tolerability in more than fifty subjects who are treated with XF-73 or placebo.
• • On October 17, 2012, an early-stage clinical trial of a novel topical antimicrobial compound known as XF-73 has been launched at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland. This compound is administered nasally and has shown promise for eliminating Staphylococcus aureus bacteria in the nose, a therapeutic approach that reduces the risk of staph infections. The study is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is taking place at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland.
• Previously, XF-73 was tested in three early-stage trials in Europe and showed promising safety, tolerability and efficacy results. In the new NIAID-funded trial, currently enrolling healthy men and women ages 18 to 45, scientists will assess the safety and tolerability of a modified, thinner gel version of the formula tested in Europe. They will also compare participants’ systemic absorption of the XF-73 compound from the modified gel, the previously tested gel and placebo and the ability of each treatment to eliminate S. aureus bacteria.
• • On March 26, 2012, Destiny Pharma has announced that its lead drug for the prevention of post-surgical Staphylococcal infections, XF-73 has progressed through the FDA to an open Investigational New Drug (IND) status and Phase I clinical evaluation is being initiated in the US. The clinical trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This latest evaluation follows three successful XF-73 clinical trials in the UK. The clinical trial will study Staphylococcus aureus (SA) decolonisation as well as safety and tolerability in more than fifty subjects who are treated with XF-73 or placebo. The study will go beyond the UK trials by more accurately simulating patient SA decolonisation, important in mitigating the risk of subsequent SA infection. Studies to date have shown XF-73 is rapidly bactericidal and has unique abilities to prevent bacterial resistance.

Is general: Yes