Palatin Technologies Announces Positive Results From its Phase 2 Study of PL9643 in Patients With Dry Eye Disease

Statistically Significant Improvement in Moderate-to-Severe Patients for Multiple Sign and Symptom Measures

Phase 2/3 Clinical Trial Currently Planned for Mid-2021

Conference Call and Webcast Today at 8:00 a.m. ET

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Dec 15, 2020, 07:00 ET

CRANBURY, N.J., Dec. 15, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, today announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease (DED). Statistically significant improvement in multiple signs and symptoms was achieved in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit. There were no safety signals identified and PL9643 had excellent ocular tolerability. However, statistical significance for the primary endpoints was not reached in the overall enrolled population that included mild, moderate, and severe patients, as measured at the 12-week primary evaluation visit.

"This was our first study evaluating a melanocortin agonist in an ocular disease and we are pleased that the key goals of this study were met, which was providing significant clinical evidence of efficacy, safety, and tolerability in a meaningful patient population - patients suffering from moderate to severe DED," stated Carl Spana, Ph.D., President and CEO of Palatin. "Importantly, we have a clear development and regulatory path forward. With approximately 20 million adults in the United States currently suffering from DED, the majority being moderate to severe patients, and up to 50% discontinuing treatment due to slow onset, lack of efficacy or intolerance, PL9643's potentially quick onset of efficacy and excellent tolerability profile are differentiating factors to current approved therapies."

In the sub-population of moderate to severe patients (N=61), PL9643 achieved statistical significance (P value <0.05 vs. vehicle) at week 2 and week 12 for multiple signs, including inferior (the primary sign endpoint), superior, and total corneal staining, temporal, nasal and total conjunctival staining, tear film break-up time, and multiple ocular symptoms, including ocular discomfort. Additionally, multiple sign and symptom measures trended towards significance (P value <0.1 vs. vehicle). Based on these positive trial results, Palatin plans to initiate a Phase 2/3 trial in the United States in mid calendar year 2021.

"This work, utilizing the melanocortin pathway, is an excitingly novel departure from all other dry eye therapeutic strategies," said Kenneth Kenyon, M.D., Principal Investigator for the study, cornea specialist at New England Eye Center and Professor of Ophthalmology, Tufts University School of Medicine. "The demonstrated consistency of improved outcomes across multiple sign and symptom time points is most impressive. Significant improvement in both corneal and conjunctival staining is highly relevant, as it affects both vision and irritative symptoms, especially so in these more advanced dry eye patients. The emerging profile of PL9643, with its rapid therapeutic onset and excellent tolerability profile, is a potentially distinct advance in dry eye therapy."

"The Phase 2 study of PL9643 has provided guidance on the clinical and regulatory pathway forward for this program. The results identify the most appropriate patient population, endpoints, and timepoints for the next study. We look forward to working with Palatin to confirm the therapeutic potential of PL9643 in treating the signs and symptoms of dry eye" said George Ousler, Senior Vice President, Anterior Segment at Ora, Inc.

This Phase 2 study was a multi-center, randomized, double-masked and vehicle-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to vehicle for the treatment of the signs and symptoms of dry eye. The study enrolled 160 participants randomized in a 1:1 ratio into two arms, PL9643 or vehicle, at four sites in the United States. Patients underwent 12 weeks of daily treatment. The intent to treat (ITT) population included all patients with mild-moderate-severe DED. The two prespecified primary endpoints were improvement in inferior corneal staining (sign) and ocular discomfort (symptom) as measured at the 12-week primary evaluation visit. There were multiple secondary sign and symptom outcome measures as well.

Trial results demonstrated an excellent safety and tolerability profile. There were no serious adverse events associated with study treatment observed. Three patients on placebo and one patient on PL9643 (not deemed to be drug related) discontinued from the study. Importantly, there were no ocular, drug-related adverse events in the PL9643 subjects.

Detailed study results are anticipated to be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on December 15, 2020 at 8:00 a.m. Eastern Time to discuss its Phase 2 study of PL9643 in greater detail. Individuals interested in listening to the conference call live can dial 1-800-367-2403 (US/Canada) or 1-334-777-6978 (international), conference ID 2038353. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin's website at http://www.palatin.com. A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 2038353. The webcast and telephone replay will be available through December 22, 2020.

About Dry Eye Disease (DED)

Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.

About Ora, Inc.

Ora is the world's leading full-service ophthalmic CRO and product development firm with offices in the United States, the United Kingdom and Japan. Over the past 40 years, Ora has helped clients earn 45 product approvals. Ora supports a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects. For more information about Ora, please go to www.oraclinical.com.

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 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 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 be 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, results of clinical trials, 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.

SOURCE Palatin Technologies, Inc.