Diabetic Foot Ulcer Spray Fails Phase 3 Test

BioChaperone PDGF is equivalent to placebo

Disappointing results have been reported from a phase 3 trial of BioChaperone PDGF (BC PDGF, Adocia) in the treatment of diabetic foot ulcers. In the study, which was conducted in India, BC PDGF did not meet the primary endpoint of a statistically significant improvement over placebo in complete wound closure after 20 weeks of treatment.

The randomized, double-blind, multicenter, outpatient study enrolled 252 patients with chronic diabetic foot ulcers. In addition to standard of care, the patients were treated every two days for a maximum of 20 weeks with either a spray containing BC PDGF or a placebo spray consisting of saline solution.

Diabetic foot ulcers are chronic wounds in which secondary infection can lead to amputation. Treatment options remain limited. In many countries, including the United States, the only biologic product approved to treat the disorder is becaplermin (Regranex, Smith & Nephew), a platelet-derived growth factor (PDGF) gel for topical application.

In a previous phase 1/2 trial, the BC PDGF spray formulation showed wound-closure efficacy that was at least equivalent to that of becaplermin at one-third the weekly dosage and when applied half as often.

Adocia’s proprietary BioChaperone technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. The company customizes BioChaperone to each protein for a given application in order to address specific patient needs.

Adocia’s clinical pipeline includes four new insulin formulations for the treatment of diabetes: two ultra-rapid formulations of insulin analogs (BioChaperone Lispro U100 and U200); a rapid-acting formulation of human insulin (HinsBet U100); and a combination of insulin glargine and a rapid-acting insulin analog (BioChaperone Combo). Adocia is also developing an aqueous formulation of human glucagon (BioChaperone Glucagon) and a concentrated, rapid-acting formulation of human insulin (HinsBet U500); both are at the preclinical stage of development.

In December 2014, Adocia signed a partnership with Eli Lilly for the development and commercialization of the BioChaperone Lispro projects.

Source: Adocia; August 25, 2016.