OKYO Pharma to Complete Enrollment of Neuropathic Corneal Pain Trial by End of Second Quarter
OKYO Pharma provided updates on its clinical trials and financial results for the six months ended September 30, 2024. The company expects to complete enrollment of 48 patients in its Phase 2a trial of OK-101 for Neuropathic Corneal Pain (NCP) by Q2 2025, with top-line data expected in Q4 2025.
Earlier in January 2024, OKYO reported positive top-line data from its Phase 2b trial of OK-101 for Dry Eye Disease (DED). The drug showed statistically significant benefits in total conjunctival staining by Day 29 and improved symptoms like burning/stinging and blurred vision. The safety profile was favorable, with TEAEs similar to placebo.
Financially, OKYO reported total assets of $2.8 million as of September 2024, including $1.0 million in cash, with an additional $1.8 million received post-period. The company's comprehensive loss decreased to $3.1 million compared to $8.5 million in the same period last year.
OKYO Pharma ha fornito aggiornamenti sui suoi trial clinici e risultati finanziari per i sei mesi terminati il 30 settembre 2024. La società prevede di completare l'arruolamento di 48 pazienti nel suo trial di Fase 2a di OK-101 per il dolore corneale neuropatico (NCP) entro il secondo trimestre del 2025, con dati provvisori attesi nel quarto trimestre del 2025.
All'inizio di gennaio 2024, OKYO ha riportato dati provvisori positivi dal suo trial di Fase 2b di OK-101 per la sindrome dell'occhio secco (DED). Il farmaco ha mostrato benefici statisticamente significativi nella colorazione congiuntivale totale entro il giorno 29 e ha migliorato sintomi come bruciore/pungente e visione offuscata. Il profilo di sicurezza è stato favorevole, con eventi avversi trattati simili al gruppo placebo.
Dal punto di vista finanziario, OKYO ha riportato un totale attivo di 2,8 milioni di dollari al 30 settembre 2024, inclusi 1,0 milione di dollari in contante, con ulteriori 1,8 milioni di dollari ricevuti dopo il periodo. La perdita complessiva della società è diminuita a 3,1 milioni di dollari rispetto agli 8,5 milioni di dollari nello stesso periodo dell'anno scorso.
OKYO Pharma proporcionó actualizaciones sobre sus ensayos clínicos y resultados financieros para los seis meses finalizados el 30 de septiembre de 2024. La compañía espera completar la inclusión de 48 pacientes en su ensayo de Fase 2a de OK-101 para el dolor corneal neuropático (NCP) para el segundo trimestre de 2025, con datos preliminares esperados en el cuarto trimestre de 2025.
A principios de enero de 2024, OKYO informó datos preliminares positivos de su ensayo de Fase 2b de OK-101 para la enfermedad del ojo seco (DED). El fármaco mostró beneficios estadísticamente significativos en la coloración conjuntival total para el día 29 y mejoró síntomas como ardor/punzada y visión borrosa. El perfil de seguridad fue favorable, con eventos adversos tratados (TEAE) similares al placebo.
Desde el punto de vista financiero, OKYO reportó activos totales de 2.8 millones de dólares al 30 de septiembre de 2024, incluidos 1.0 millón de dólares en efectivo, con 1.8 millones de dólares adicionales recibidos después del periodo. La pérdida integral de la compañía se redujo a 3.1 millones de dólares en comparación con los 8.5 millones de dólares del mismo periodo del año pasado.
OKYO Pharma는 2024년 9월 30일 종료된 6개월 동안의 임상 시험 및 재무 결과에 대한 업데이트를 제공했습니다. 이 회사는 신경병성 각막 통증(NCP)에 대한 OK-101의 2a 상 시험에서 48명의 환자 등록을 2025년 2분기까지 완료할 것으로 예상하며, 2025년 4분기에 주요 데이터가 발표될 것으로 기대하고 있습니다.
2024년 1월 초, OKYO는 건성 안구 질환(DED)에 대한 OK-101의 2b 상 시험에서 긍정적인 주요 데이터를 보고했습니다. 이 약물은 29일째에 총 결막 착색에서 통계적으로 유의미한 이점을 보였으며, 따가움/쑤심 및 흐릿한 시력과 같은 증상을 개선했습니다. 안전성 프로필은 긍정적이었으며, 치료 관련 부작용(TEAE)은 위약 그룹과 유사했습니다.
재무적으로, OKYO는 2024년 9월 30일 기준 총 자산 280만 달러를 보고했으며, 그 중 100만 달러가 현금으로 포함되어 있고, 이후 기간에 180만 달러가 추가로 수령되었습니다. 회사의 종합 손실은 지난해 같은 기간에 비해 850만 달러에서 310만 달러로 감소했습니다.
OKYO Pharma a fourni des mises à jour concernant ses essais cliniques et ses résultats financiers pour les six mois se terminant le 30 septembre 2024. La société prévoit de compléter l'inscription de 48 patients dans son essai de Phase 2a de OK-101 pour la douleur cornéenne neuropathique (NCP) d'ici le deuxième trimestre 2025, avec des données préliminaires attendues au quatrième trimestre 2025.
Au début de janvier 2024, OKYO a signalé des données préliminaires positives de son essai de Phase 2b de OK-101 pour la maladie de l'œil sec (DED). Le médicament a montré des avantages statistiquement significatifs dans la coloration conjonctivale totale d'ici le jour 29 et a amélioré des symptômes tels que la brûlure/pique et la vision floue. Le profil de sécurité était favorable, avec des événements indésirables traités (TEAE) similaires à ceux du placebo.
Sur le plan financier, OKYO a rapporté des actifs totaux de 2,8 millions de dollars au 30 septembre 2024, dont 1,0 million de dollars en espèces, avec 1,8 million de dollars supplémentaires reçus après la période. La perte globale de la société a diminué à 3,1 millions de dollars contre 8,5 millions de dollars au cours de la même période de l'année dernière.
OKYO Pharma hat Updates zu seinen klinischen Studien und finanziellen Ergebnissen für die sechs Monate zum 30. September 2024 bereitgestellt. Das Unternehmen erwartet den Abschluss der Rekrutierung von 48 Patienten in seiner Phase 2a-Studie zu OK-101 für neuropathische Hornhautentzündung (NCP) bis zum 2. Quartal 2025, wobei die Hauptdaten im 4. Quartal 2025 erwartet werden.
Anfang Januar 2024 berichtete OKYO über positive Hauptdaten aus seiner Phase 2b-Studie zu OK-101 für sichere Augenkrankheit (DED). Das Medikament zeigte statistisch signifikante Vorteile in der gesamten Bindehautfärbung bis Tag 29 und verbesserte Symptome wie Brennen/Piksen und verschwommenes Sehen. Das Sicherheitsprofil war günstig, mit ähnlichen unerwünschten Ereignissen (TEAE) wie bei Placebo.
Finanziell berichtete OKYO über Gesamtaktiva von 2,8 Millionen Dollar zum 30. September 2024, darunter 1,0 Millionen Dollar in bar, wobei nach dem Zeitraum weitere 1,8 Millionen Dollar empfangen wurden. Der Gesamtschaden des Unternehmens verringerte sich auf 3,1 Millionen Dollar im Vergleich zu 8,5 Millionen Dollar im selben Zeitraum des Vorjahres.
- Received first FDA IND clearance to clinically evaluate a drug specifically for NCP treatment
- Phase 2b trial for DED showed statistically significant benefits in multiple endpoints
- Favorable safety profile in DED trial with TEAEs similar to placebo
- Reduced comprehensive loss from $8.5M to $3.1M year-over-year
- Increased total assets from $1.5M to $2.8M since March 2024
- Operating with cash reserves of $1.0M as of September 2024
- Continued financial losses of $3.1M in the six-month period
Insights
OKYO Pharma's clinical developments represent a potentially transformative opportunity in the ophthalmology space. The company's OK-101 program is pursuing two significant market opportunities: neuropathic corneal pain (NCP), an untapped market with no FDA-approved treatments and dry eye disease (DED), a multi-billion-dollar market.
The NCP trial's progression is particularly significant for three key reasons:
- First-mover advantage: OKYO secured the first-ever FDA IND clearance for NCP treatment, establishing a pioneering position in this unmet medical need
- Trial design optimization: The involvement of Dr. Hamrah, a leading NCP expert, strengthens the trial's credibility and potential for success
- Clear timeline visibility: Expected completion of enrollment by Q2 2025 and top-line data in Q4 2025 provides concrete catalysts
The recently completed Phase 2b DED trial delivered compelling results, with statistically significant improvements in both signs and symptoms:
- Demonstrated efficacy as early as Day 15 for key symptoms
- Favorable safety profile with fewer drug-related adverse events than placebo
- Multiple endpoint achievements strengthen the potential for Phase 3 success
However, investors should note the company's financial position requires attention. With
LONDON and NEW YORK, Jan. 29, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, today announces a clinical update and its interim results for the six months ended 30 September 2024.
Clinical Updates:
OK-101
Neuropathic Corneal Pain (NCP)
The Company anticipates completing enrollment of the 48-patient trial by the end of 2Q 2025 and releasing top-line data on the Phase 2a trial in 4Q 2025. Results from this trial are anticipated to be a major binary event for the Company.
During the past six months of 2024 the OKYO Pharma’s primary focus has been centered on preparations for and the initiation of the first clinical trial of a drug to treat NCP, with the announcement on 23 October, 2024 of the opening of a Phase 2a trial of OK-101 to treat NCP. The Phase 2a study is designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients. A total of 48 patients are planned to be enrolled in the trial, with NCP disease confirmed via confocal microscopy, patient symptoms and medical histories.
OK-101, a novel, non-opioid therapeutic candidate, is designed to target and alleviate the debilitating pain associated with corneal nerve damage, a condition for which there are currently no U.S. Food and Drug Administration (FDA) approved treatments. Neuropathic corneal pain, often resulting from conditions like dry eye disease, surgery, or infections, can severely impact a patient’s quality of life, with current management options limited to pain relief strategies that offer only partial or temporary respite.
Earlier in the year, in February 2024, the Company announced that it was the first company to receive an investigational new drug (IND) application clearance by FDA to clinically evaluate a drug specifically to treat NCP with the clearance of the IND for OK-101.
The OK-101 trial is designed as a single-center trial and is being led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator. Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, and Director of the Center for Translational Ocular Immunology at Tufts Medical Center. He is one of the world’s foremost experts on NCP and treats patients with ocular pain from across the United States and worldwide. His previous research has demonstrated safety and efficacy of various topical and systemic treatments for ocular pain and has led to the development of new diagnostic markers for ocular pain by in vivo confocal microscopy. In addition to his work on OK-101, of which he is a co-inventor and member of OKYO’s Scientific Advisory Board, Dr. Hamrah is also conducting studies on developing new corneal nerve function tests and is a consultant to the company covering non-clinical studies of OK-101 to evaluate its mechanism of action.
Dry Eye Disease (DED)
In January of 2024, OKYO reported positive top line data from the Phase 2b trial of OK-101 to treat DED patients. This OK-101 first-in-human Phase 2b trial established a clear clinical path for potential further clinical development via a Phase 3 study design using FDA-recognized endpoints. OK-101 demonstrated statistically significant benefit in a “sign” endpoint, namely “total conjunctival staining” as measured by the Ora Calibra© Staining Scale as early as Day 29 (p = 0.034). OK-101 also improved at least two “symptom” endpoints of DED, including “burning/stinging” as measured by the Ora Calibra© 4-symptom questionnaire, and as measured by a visual analog scale as early as Day 15 (p = 0.04 and p=0.03, respectively), as well as “blurred vision”, with statistically significant improvement in blurred vision occurring by Day 29 (p = 0.01).
Of the 240 patients treated in the trial, treatment emergent adverse events (TEAEs) were observed to be similar to the placebo-treated group. No severe drug related ocular TEAEs were seen. Possible drug-related TEAEs were observed in one patient in the OK-101
OKYO is planning to engage with the FDA on the next clinical plans for OK-101 to treat DED.
Financial Highlights:
- Total assets of
$2.8 million (31 March 2024:$1.5million ) - Cash on hand of
$1.0 million (31 March 2024:$0.8 million ); post period end the Company received additional cash of$1.8 million . - During the financial period under review, the Company reported a total comprehensive loss of
$3.1 million (compared to total comprehensive loss of$8.5 million for the six months ending September 30 2023)
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of NCP and DED, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat NCP and inflammatory DED. In addition to the completed Phase 2 trial of OK-101 to treat DED patients, OKYO is also currently evaluating OK-101 to treat NCP patients in a Phase 2 trial.
Enquiries:
| OKYO Pharma Limited | Gary S. Jacob, Chief Executive Officer | U.S. 917-497-7560 |
| Business Development & Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |
FAQ
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