CRANBURY, N.J., June 23, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced it 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."
Dr. Spana further commented, "The adaptive design of the Phase 2 clinical study will provide early and multiple looks at the results, allowing us to assess the effectiveness of PL8177 and possible study modifications for patient benefit."
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.
About Palatin Technologies, Inc. Palatin Technologies, Inc. is a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com.
Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about potential utility of candidate products in treatment of COVID-19, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements are subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.