July 2,2020

Palatin Technologies is developing PL8177 as a treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus, 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.

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 the Company 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. Required preclinical and Phase 1 safety studies are complete and support the safe use of PL8177 in a Phase 2 clinical study. In addition, Palatin is pursuing multiple sources for research and development grants to support PL8177 clinical development.

"We are excited about PL8177's potential to be part of the solution to this unprecedented global public health crisis," said Carl Spana Ph.D., President and CEO of Palatin. "What is differentiating about PL8177 is its potential to reduce the inflammation associated with progressive COVID-19 disease and to reduce lung fibrosis, which can compromise patient lung function after recovering from the viral infection."

PL8177, a potent and selective melanocortin 1 receptor (MC1r) agonist, has demonstrated efficacy in multiple preclinical models of inflammatory disease and reduced lung tissue damage and fibrosis in a preclinical model of lung fibrosis.

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. PL8177 will be delivered as a sterile subcutaneous injection. The study will randomize patients (1:1) to a placebo plus standard of care control group or PL8177 plus standard of care treatment group. The study population will be hospitalized adult COVID-19 subjects with hypoxemic respiratory failure, with or without mild ARDS. The study will use an adaptive design with an independent Data Monitoring Committee examining the results when 25%, 50%, 75%, and 100% of the maximum sample size (176 patients, 88 per arm) has been enrolled and either completed the study or withdrawn prematurely.