Beskrivning
| Land | Norge |
|---|---|
| Lista | Euronext Growth Oslo |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
2022-04-28 13:15:53
SoftOx Solutions AS (SoftOx), a clinical-stage biopharmaceutical company based
in Norway, announces that the final patient in the fourth and last single-dose
cohort of the SBE-01 clinical study has been treated today. This completes the
first part (SAD* phase Ia) of SBE-01 and allows the study to advance to the last
phase (MAD** phase Ib). SBE-01 (EudraCT no. 2021-000314-42) is the first-in-man
(phase I) study with the SoftOx' lead wound care product, SBE (SoftOx Biofilm
Eradicator), designed to treat infected chronic wounds. The study will establish
a tolerable dose and treatment schedule for SBE to be able to develop it into an
effective infection-treatment solution in problematic, non-healing wounds.
"Besides the satisfactory uptake of patients in the recent weeks, the study
progression is also a result of no safety concerns that have impacted the
activity of the study. Although still early in the study, it is encouraging to
observe that our solutions are well tolerated in chronic wounds and confirm what
was documented in previous animal wound models", says Glenn Gundersen, Chief
Medical Officer in SoftOx Solutions.
With the upcoming final decision from the Safety Monitoring Committee, the MAD
phase (Ib) will be activated. In this part of the SBE-01 study we will test the
tolerable SBE-products once or multiple times daily over 5 days. This will
document even further on safety, tolerability, and efficacy when SBE is
administered on a more intense and clinically relevant treatment schedule.
* SAD: single ascending dose, **MAD: Multiple ascending dose
For further information, please contact:
Geir Almås, CEO of SoftOx Solutions AS, or
Glenn Gundersen, CMO of SoftOx Solutions AS
Mail: ir@soft-ox.com
Phone: Front Desk: (+47) 948-59-599
About SoftOx Solutions AS
SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian
biotech/medtech company based in Oslo with the aim of helping to combat major
threats to human health, namely the emergence of antimicrobial resistance (AMR),
biofilm infections in chronic wounds and the spread of viruses. For more
information on SoftOx, visit www.soft-ox.com