OKYO Pharma Moves Forward with Groundbreaking Pain Treatment Trial

OKYO Pharma's Advancements in Neuropathic Corneal Pain Treatment

OKYO Pharma Limited (NASDAQ: OKYO), an innovative biopharmaceutical company, has embarked on a promising journey to tackle neuropathic corneal pain (NCP). This ocular condition can inflict chronic and severe pain with no FDA-approved treatment options currently available. In an exciting announcement, OKYO revealed its intentions to initiate a multi-center clinical trial involving 100 patients that will significantly progress the development of their lead drug candidate, urcosimod.

Promising Results from Phase 2 Clinical Trial

The recent developments follow an encouraging Phase 2 proof-of-concept trial. Conducted at Tufts Medical Center, the trial assessed the efficacy of urcosimod in 17 patients suffering from NCP. Led by Dr. Pedram Hamrah, a renowned expert in the field, the trial's findings showcased a remarkable 75% of participants experiencing a substantial reduction of over 80% in pain levels after a 12-week treatment period with a 0.05% urcosimod dosage.

Progressing to the Multi-Ascending Dose Trial

Building on this success, OKYO is preparing for a multiple-ascending-dose (MAD) trial aimed at refining the registration pathway for urcosimod. This trial is set to recruit approximately 100 NCP patients across multiple clinical sites in the U.S. to gather critical information necessary for future Phase 3 studies. The trial will focus on:

• Establishing the optimal dose for FDA registration of urcosimod.
• Enhancing the understanding of the drug’s unique micellar characteristics.
• Providing data essential for drawing conclusions regarding the efficacy of urcosimod.

Regulatory Engagement and Future Steps

As part of its registration strategy, OKYO is actively engaging with the U.S. Food and Drug Administration (FDA) to clarify the requirements for securing approval for NCP treatment. Urcosimod has been granted Fast-Track designation by the FDA, expediting the regulatory process. This designation is pivotal in enhancing the speed of discussions with the FDA regarding the primary endpoint required for drug registration.

CEO Commentary on Trial Outcomes

Gary S. Jacob, Ph.D., the CEO of OKYO Pharma, expressed optimism regarding their recent Phase 2 trial results, noting, "The encouraging outcomes indicate substantial pain relief for a significant percentage of patients. This advancement represents a crucial step toward delivering effective treatment options for those suffering from NCP, who often struggle to find relief." He also highlighted the urgency to commence the upcoming MAD trial, emphasizing an efficient pathway to deliver much-needed therapy to patients.

NCP: A Significant Unmet Medical Need

Neuropathic corneal pain is a debilitating condition characterized by intense pain and sensitivity in the eyes, face, or head, often stemming from nerve damage and inflammation. Currently, patients rely on off-label treatments, resulting in limited relief, underscoring the pressing need for effective therapies. Without FDA-approved options, the situation is dire and demands immediate attention from biopharmaceutical innovators like OKYO.

Urcosimod and Its Mechanism

Urcosimod is a specially developed lipid-conjugated chemerin peptide, designed to interact with ChemR23 receptors—integral to inflammatory responses within the ocular system. This unique formulation allows for a prolonged therapeutic effect, making urcosimod a promising candidate for combating ocular diseases. Prior studies have indicated its potential in alleviating both inflammation and pain, solidifying its role in treating conditions like dry eye disease and NCP.

Commitment to Innovation in Eye Health

OKYO Pharma is unwavering in its mission to pioneer innovative treatments for eye-related ailments. With ongoing research and clinical development phases underway, the company aims to transform the management of neuropathic corneal pain and dry eye disease significantly. The completion of the upcoming MAD trial will bring them one step closer to delivering effective, novel therapies to patients awaiting relief.

Frequently Asked Questions

What is urcosimod, and how does it work?

Urcosimod is a lipid-conjugated chemerin peptide that targets receptors in the eye responsible for inflammatory responses, designed to treat neuropathic corneal pain and dry eye disease.

What were the results of the Phase 2 trial?

In the Phase 2 trial, 75% of patients treated with 0.05% urcosimod experienced over 80% pain relief after 12 weeks, indicating its potential effectiveness.

Where will the upcoming clinical trial take place?

The next clinical trial will enroll around 100 patients across several clinical sites in the United States.

What distinguishes OKYO Pharma in the biopharmaceutical industry?

OKYO Pharma focuses on developing innovative therapies specifically for neurological and ocular conditions, meeting a vital need in the healthcare market.

What is the anticipated timeline for the upcoming trial results?

Topline data from the upcoming multiple-ascending-dose trial is expected to be released in 2026, depending on the trial's progress.

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