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OKYO Pharma
Announces
OK-101
Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of
Dry Eye Disease
including
Ocular Pain
Relief in its First-in-Human Phase 2 Trial of
OK-101
2024-03-22
·
BioSpace
临床结果
临床2期
Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial. Conjunctival Staining improved as early as day 29 with a durable benefit throughout the trial. Tear Film Break-up Time showed statistically significant improvement as early as day 15 with the benefit durable for the remainder of the trial. Burning/Stinging, and Blurred Vision improved as early as day 15 and the benefit remained durable throughout the trial. Significant improvements were observed across multiple symptoms as measured in a daily symptom diary including
pain
,
burning/stinging
, eye dryness and
itching
within the first two weeks of treatment.
OK-101
exhibited exceptional drop comfort, comparable to that of artificial tear, with very good ocular tolerability along with a favorable adverse event pro no drug-related serious adverse events. These observed endpoints support the proposed mechanism-of-action of
OK-101
as demonstrated in preclinical animal models. LONDON and NEW YORK, March 22, 2024 (GLOBE NEWSWIRE) --
OKYO Pharma Limited
(NASDAQ:
OKYO
), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of
inflammatory dry eye disease (DED)
, a multi-billion-dollar market, and
anterior ocular segment diseases
including
neuropathic corneal pain (NCP)
, an ocular condition associated with
pain
but without an FDA approved therapy, announced today additional key findings from analyses of the clinical data set from the 240 patient Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with DED. These new findings include: a statistically significant and durable reduction in
ocular pain
statistically significant improvement in Tear Film Break-Up Time (TFBUT) throughout the study - a clinically important endpoint multiple symptomatic improvements as observed by both data obtained from patient clinic visits as well as data from patient daily symptom diaries These results complement the statistically significant effects reported earlier on sign and symptoms endpoints, enabling definitive Phase 3 development of
OK-101
; using FDA recognized endpoints per the
Dry Eye
: Developing Drugs for Treatment Guidance for Industry. . The Company previously reported statistically significant improvements in total conjunctival staining (a sign endpoint), as measured by the
Ora
Calibra© Staining Scale as early as Day 29 (p = 0.034) and
burning/stinging
and blurred vision (symptom endpoints) measured by a visual analogue scale (VAS) as early as Day 15 for
burning/stinging
(p=0.03), and at Day 29 (p = 0.01) for blurred vision. This Phase 2 trial was conducted by our CRO partner
Ora Inc.
In this press release, the Company is reporting additional
OK-101
data, including conjunctival staining measured at Day 85 (p=0.056) demonstrating durability in this sign endpoint. In addition, there were significant improvements in
burning/stinging
(p = 0.01, 0.006, 0.003 and 0.01 at Days 15, 29, 57 and 85, respectively) and in blurred vision (p = 0.09, 0.01, 0.03 and 0.06 at Days 15, 29, 57 and 85, respectively) which demonstrated sustained improvements throughout the trial. Additional data analyses also showed statistically significant improvement in
ocular pain
measured by VAS that was durable throughout the trial with p values = 0.03, 0.04 and 0.01 at Days 29, 57 and 85, respectively. Furthermore,
OK-101
improved TFBUT as early as Day 15 and the improvement lasted throughout the trial with p values = 0.01, 0.05, 0.02, and 0.03 at Days 15, 29, 57 and 85, respectively. Notably, it has been difficult to demonstrate statistical significance for the measurement of increase in TFBUT in clinical trials of DED treatments, due mainly to patient-to-patient variability. The positive results observed in this trial carry particular significance as
OK-101
’s proposed MOA involves the normalization of goblet cell density as well as generating a healthier conjunctiva, a reduction of
ocular pain
and decreased inflammatory activity. An increase in goblet cell density should be expected to lead to an increase in mucin production, playing a key role in the physiology of the corneal tear film. Importantly, data obtained from daily symptom diaries maintained by patients during the trial, commonly referred to as patient-reported outcome data, confirmed several of the
DED
symptoms also measured in the clinic, exhibiting significant improvements as early as Day 1 through Day 15 for
pain
,
burning/stinging
, eye dryness and
itching
, with p values of 0.01, 0.06, 0.005 and 0.009, respectively. This observation of statistically significant improvements in multiple
DED
symptoms as measured both from clinic visits and as reported by patients at home is striking. Lastly,
OK-101
was extremely well tolerated with a drop comfort score of 2.3 after 2 minutes post-instillation which is comparable to those of artificial tear results as measured by the
Ora
Calibra© Drop Comfort Scale1 of 0–10, with a value of 0 being most comfortable and 10 being least comfortable. Notably,
OK-101
exhibited placebo-like tolerability with a very low adverse event pro no drug-related serious adverse events. The number of treatment emergent adverse events (TEAEs) were observed to be similar to that of the placebo-treated group. And no severe drug related ocular TEAEs were seen. Possible drug-related TEAEs were observed in one patient in the
OK-101
0.05% treatment group (n=81) and 3 patients in the placebo-treated group (n=79), again highlighting the favorable safety pro
OK-101
. “The positive impact of
OK-101
, in its capacity to rapidly and durably improve tear film break up time, is particularly relevant for so many
dry eye
patients who have reduced blink rate associated with extensive screen time, reading and driving,” said Jay Pepose, M.D., Ph.D., Founder and Medical Director of
Pepose Vision Institute
and Professor of Clinical Ophthalmology at Washington University School of Medicine in St. Louis. “This improvement in tear film stability correlates well with the improvement of multiple
dry-eye
associated symptoms, such as blurred vision. A rapid tear film break-up time is observed in all forms of
dry eye disease
, including aqueous deficiency, evaporative and mixed.” “Our enthusiasm for the highly differentiated benefits of
OK-101
in treating
dry eye
patients continues to build,” said Dr. Gary S. Jacob, CEO of
OKYO
. “
OK-101
is the first investigational
DED
therapeutic, to our knowledge, to demonstrate statistically significant and durable improvements in both tear-film breakup time, and
ocular pain
. What is exciting to us is the totality of the data that we are seeing, including the improvement in conjunctival integrity, positive increase in tear-film breakup time, and improvements in the symptom endpoints of burning and stinging and blurry vision, all supporting the proposed MOA that we uncovered in preclinical animal models. Finally,
OK-101
also appears to act quickly, displaying rapid reduction of ocular DED symptoms. These clinical benefits combined with
OK-101
’s exceptional tolerability pro
OK-101
a novel and promising therapeutic agent with the potential for a market leading position in
DED
.” The company will be hosting a Key Opinion Leader event featuring Jay Pepose, MD, PhD, and Anat Galor, MD, MSPH, who will discuss these significant findings in depth. Event Details: April 9th, 2024, 12:00 PM ET Link to Register: 1 Torkildsen et al. Clinical Ophthalmology 2017:11 1883–1889
OK-101
Phase 2 Trial in
DED
Patients The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with
DED
dosed twice-daily (BID). Patients were randomly divided into 3 cohorts, with one of the cohorts dosed with 0.05%
OK-101
(n=81), a second with 0.1%
OK-101
(n=80), and the third cohort with vehicle (n=79). The duration of a patient’s treatment was 14 weeks, including a 2-week run-in period on placebo, to exclude placebo responders from the study, followed by 12 weeks in the randomized portion of the study. About
OK-101
OK-101
is a lipid conjugated
chemerin peptide
agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response.
OK-101
was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating
dry eye disease
.
OK-101
has been shown to produce anti-inflammatory and pain-reducing efficacy signals in mouse models of
dry eye disease
and
corneal neuropathic pain (NCP)
, respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to enhance the residence time of
OK-101
within the ocular environment.
OK-101
recently showed statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled trial of
OK-101
to treat
DED
. About
OKYO
OKYO Pharma Limited
(NASDAQ:
OKYO
) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of
DED
and NCP, with ordinary shares listed for trading on the NASDAQ Capital Market.
OKYO
is focused on the discovery and development of novel molecules to treat
inflammatory DED
and
ocular pain
. In addition to the recently completed Phase 2 DED trial,
OKYO
also has plans underway for the opening of a Phase 2 trial for
OK-101
to treat NCP in patients with this debilitating condition. For further information, please visit . About
Ora, Inc.
Ora
is a world-leading full-service ophthalmic drug and device development firm with offices in North America, South America, Europe, and Asia. For over 45 years, the company has helped clients earn more than 85 product approvals.
Ora
’s pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. The company brings together the world’s most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives. For more information, please visit and follow us on LinkedIn. Forward-Looking Statements Certain statements made in this announcement are forward-looking statements, including with respect to the anticipated timing of completion of enrolment of the Company’s Phase 2 trial of topical ocular
OK-101
to treat
DED
and the release of top-line data therefrom. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. Enquiries:
OKYO Pharma Limited
Gary S. Jacob, Chief Executive Officer 917-497-7560 Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379
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机构
OKYO Pharma Ltd.
Ora, Inc.
Pepose Vision Institute
适应症
干眼综合征
眼睛疼痛
疼痛
[+6]
靶点
Chemerin receptors
药物
OK-101
标准版
¥
16800
元/账号/年
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