Don’t throw the baby out with the bath water. The entire report is always worth reading. While it’s not de-risking by any means, there is still potential.
“As this was a Phase 1 trial, the design was not optimized for assessing efficacy with respectto scar improvement. Indeed, the inclusion and exclusion scar criteria were deliberately broad tofacilitate recruitment focused on demonstrating safety and identifying adverse events. Thisresulted in many participants having normotrophic, flat and pliable scars at baseline, as well assignificant differences in the baseline characteristics of the placebo and PXS-6302 treatmentgroups that may limit the ability to observe scar improvements as a result of PXS-6302 treatment.Patient and observer POSAS scores were conflicting, highlighting the challenges associated withusing subjective scar scales to provide accurate clinical assessments of scar, and the continuedneed for objective measures, such as OCT, to assist in the development of therapeutics toameliorate scarring. In contrast, the objective measures applied in this study strongly suggestlysyl oxidase inhibition is an effective mechanism by which to improve scars and warrants a phase2 efficacy study.”
”A Phase 2 study will requirerecruitment of participants with hypertrophic scars, restricted to those with a high POSAS scoreto better ascertain if the molecular changes that result from lysyl oxidase inhibition improvespatient perception and appearance of their scars”.
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