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Palatin Announces Results of PL9643 MELODY-1 Pivotal Phase 3 Clinical Trial in Patients with Dry Eye Disease (DED)

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Palatin Technologies, Inc. (PTN) announces positive results from its PL9643 MELODY-1 pivotal Phase 3 clinical trial for dry eye disease. The trial met co-primary symptom endpoint with statistical significance. PL9643 showed superiority over vehicle in multiple symptom endpoints and demonstrated excellent safety. Future discussions with FDA are planned.
Positive
  • Positive results from PL9643 MELODY-1 trial for dry eye disease
  • Co-primary symptom endpoint met with statistical significance
  • Superiority of PL9643 over vehicle in multiple symptom endpoints
  • Excellent safety and tolerability profile of PL9643
  • Future discussions with FDA planned for regulatory approval
Negative
  • None.

The results from the MELODY-1 pivotal Phase 3 clinical trial for PL9643 in treating dry eye disease (DED) are significant for Palatin Technologies and the broader medical community. The trial's achievement of its co-primary symptom endpoint, specifically in pain reduction, is a noteworthy accomplishment. Clinical trials in the DED space often struggle to demonstrate efficacy due to the subjective nature of pain measurement and the high placebo effect often observed in DED studies. The statistical significance (p<0.025) indicates a low probability that the observed effects are due to chance, which bolsters the credibility of the results.

However, the inability to meet the co-primary sign endpoint and secondary sign endpoints suggests that while symptoms may be alleviated, objective clinical signs may not be as responsive to PL9643 treatment. This discrepancy could influence the perception of the drug's overall efficacy and may impact regulatory approval discussions with the FDA. The safety profile, with fewer adverse events and study discontinuations in the PL9643 arm, is encouraging and will likely be a key factor in the FDA's assessment of the drug's risk-benefit profile.

From a market perspective, the successful trial outcomes for PL9643 could position Palatin Technologies as a contender in the DED market, which is a significant segment given the estimated 38 million Americans affected. DED is a chronic condition that often requires ongoing management, thus presenting a substantial market opportunity for effective treatment options. The company's intention to seek a collaboration partner for the DED program could potentially accelerate commercialization efforts and mitigate financial risks associated with bringing a new drug to market.

Investors will likely monitor the upcoming discussions with the FDA closely, as the design of the next pivotal Phase 3 clinical trial will be crucial for the drug's approval pathway. The overall positive safety and efficacy data could be a catalyst for investor confidence, although the missed endpoints will require careful communication to manage stakeholder expectations.

Financially, the trial results for PL9643 have implications for Palatin Technologies' valuation and stock performance. Positive clinical trial outcomes can lead to increases in stock prices due to anticipated future revenue streams. However, the mixed results—success in symptom endpoints but not in sign endpoints—may lead to cautious optimism among investors. The company's next steps, including the strategy for regulatory approval and potential partnership discussions, will be critical in determining the financial trajectory.

Investors should consider the costs associated with additional trials, potential market size and the competitive landscape. The DED market already includes approved treatments and PL9643's value proposition will hinge on demonstrating differentiated benefits or improved safety profiles over existing therapies. The long-term financial impact will also depend on the drug's pricing strategy, reimbursement rates and market penetration.

  • On an Intent-to-Treat Analysis, Co-Primary Symptom Endpoint Met, Statistical Significance (P<0.025)
    • Multiple Secondary Symptom Endpoints Met, Statistical Significance (P<0.025)
  • On an Intent-to-Treat Analysis, Co-Primary Sign Endpoint and Secondary Sign Endpoints Not Met
    • PL9643 Demonstrated Superiority Over Vehicle in Multiple Sign Endpoints
  • Excellent Safety and Tolerability Profile
  • Future Discussions Planned with FDA Regarding Regulatory Approval Path
  • Company to Host Conference Call at 8:30 a.m. ET Today

CRANBURY, N.J., Feb. 28, 2024 /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 receptor system, today announced results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED).

MELODY-1 had two co-primary efficacy endpoints: one clinical symptom (pain) and one clinical sign (conjunctival lissamine green staining), as well as multiple other symptom and sign secondary endpoints of DED. Duration of treatment was 12 weeks with a 4-week run-in period. Analysis of the data indicated that both age and sex needed to be accounted for in the primary statistical analysis, (60% of the subjects were over age 60; 68% of the subjects were female). After adjusting the Intent-to-Treat (ITT) analysis for age and gender, PL9643 treatment demonstrated clinically meaningful (visual analog score reduction of >10 points from baseline) and statistically significant results for the co-primary symptom endpoint of pain (p<0.025) and multiple other symptom endpoints. PL9643 treatment for the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the ITT population but did not achieve statistical significance. In the unadjusted planned analyses, the co-primary endpoints and secondary endpoints did not reach statistical significance.

"Even with a high vehicle response, PL9643 treatment was clinically meaningful and statistically significantly effective on an ITT basis in reducing patient symptoms for the co-primary pain endpoint and multiple other symptom endpoints," said Carl Spana, Ph.D., President and CEO of Palatin. "We are pleased that PL9643 treatment demonstrated excellent safety and tolerability data, including superior efficacy results compared to vehicle across multiple sign endpoints."

"It is important to note that it is rare for one clinical study in DED to show efficacy for both a sign and a symptom. While additional analyses are ongoing, the initial results reinforce the potential of PL9643 as a treatment to address both symptoms and signs of DED," continued Dr. Spana. "Our comprehensive data analysis is ongoing, and upon completion, we plan to meet with the FDA to discuss and get feedback on the design of the next pivotal Phase 3 clinical trial. Furthermore, we will continue with our efforts for a collaboration partner for our DED program."

Safety analysis indicated PL9643 was well-tolerated. There were fewer ocular treatment related adverse events in the PL9643 arm (5.6%, N=16/288) compared to vehicle (6.3%, N=18/287), and fewer study discontinuations in the PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%, N=32/287).

PL9643 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This shows the significant unmet medical need for an effective treatment that also has an excellent safety and tolerability profile.1

The data from the pivotal Phase 3 MELODY-1 trial was a multi-center, randomized, double–masked and vehicle–controlled study that enrolled 575 patients at sites in the U.S. The trial evaluated the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED, for multiple sign and symptom endpoints, after treatment for 12 weeks. The study design was based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-Phase 2 meeting with the FDA on key elements of the pivotal Phase 3 clinical program.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on February 28, 2024, at 8:30 a.m. Eastern Time to discuss the PL9643 Phase 3 clinical study results in greater detail. Individuals interested in listening to the conference call live can dial 1-888-506-0062 (US) or 1-973-528-0011 (International), Participant Access Code: 295124. 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 or by clicking here. A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), Replay Passcode 50021. The webcast and telephone replay will be available through March 13, 2024.

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. DED affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. 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 DED is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.

References
1.  Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.

About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MCR1 through MCR5. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin 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. To learn more about Palatin, please visit us on www.Palatin.com and follow us on Twitter at @PalatinTech.

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 Palatin products in development, including PL9643, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates 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 agencies 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 events that occur after the date of this press release.

Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-announces-results-of-pl9643-melody-1-pivotal-phase-3-clinical-trial-in-patients-with-dry-eye-disease-ded-302073599.html

SOURCE Palatin Technologies, Inc.

The trial met the co-primary symptom endpoint with statistical significance and demonstrated superiority of PL9643 over vehicle in multiple symptom endpoints.

PL9643 showed excellent safety and tolerability, with fewer ocular treatment related adverse events and study discontinuations compared to the vehicle.

Dry eye disease affects an estimated 38 million people in the U.S.

Palatin Technologies plans to have discussions with the FDA for regulatory approval and seek a collaboration partner for their DED program.
Palatin Technologies Inc.

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About PTN

palatin technologies, inc., a specialized biopharmaceutical company, develops targeted receptor-specific therapeutics for the treatment of various diseases in the united states. the company's lead product is vyleesi, a melanocortin receptor agonist for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder. it is also developing oral pl8177, a selective melanocortin receptor (mcr) 1 agonist peptide that has completed phase i clinical trial for the treatment of inflammatory bowel diseases; and systemic pl8177, which has completed phase i clinical trial for treating non-infectious uveitis and covid-19. in addition, the company engages in the development of pl9643, a peptide melanocortin agonist active at multiple mcrs, including mc1r and mc5r for anti-inflammatory ocular indications, such as dry eye disease; and melanocortin peptides for diabetic retinopathy. further, it is developing pl3994, a natriuretic peptide receptor (npr)-a agonist and sy