WASHINGTON (dpa-AFX) - Biopharmaceutical company Palatin Technologies, Inc. (PTN) announced Tuesday that it is developing PL8177 as a treatment for patients with COVID-19, and having hypoxemic respiratory failure with or without acute respiratory distress syndrome (ARDS).
This decision was based on positive results in preclinical multiple inflammatory disease models and a lung injury model, which showed the ability of PL8177 to reduce inflammation, protect lung tissue and reduce lung fibrosis. PL8177 is a potent and selective melanocortin 1 receptor (MC1r) agonist.
Palatin submitted a preliminary proposal to the Biomedical Advanced Research and Development Authority (BARDA) on this program, received technical and strategic advice, and submitted a pre-Investigational New Drug (pre-IND) package to the Division of Pulmonary, Allergy, and Critical Care (DPACC) of the U.S. Food and Drug Administration (FDA).
Based on advice from DPACC, Palatin is planning to submit an IND in the third quarter of calendar year 2020 and planning a Phase 2 clinical trial initiation in the fourth quarter of calendar year 2020.
The primary objective of the phase 2 randomized controlled study will be to determine if the proportion of patients with moderate or severe illness that improve on the World Health Organization scale is significantly greater in the active arm compared to the placebo arm.
Palatin is also pursuing multiple sources for research and development grants to support PL8177 clinical development.
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