QLT Inc. Announces Results from its Multi-Center, Phase 2a Clinical Trial of Repeated Treatments of Oral QLT091001
Dec 5 14
QLT Inc. announced results from its multi-center, Phase 2a clinical trial of repeated treatments of oral QLT091001 in adult subjects with early age-related macular degeneration (AMD) and impaired dark adaptation and/or impaired low luminance vision. The Company previously announced positive results from its Phase 1b clinical trials for QLT091001 in subjects with the rare inherited retinal degenerative diseases, Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP). In this Phase 2a trial, oral doses of QLT091001 dosed once per week for 3 consecutive weeks with one additional dose the day after the third dose, showed trends in improvement in dark adaptation rate and in glare recovery time relative to placebo. QLT091001 treatment had an acceptable safety profile and was well-tolerated. This multicenter Phase 2a, randomized, placebo-controlled, single-masked, parallel-design, safety/proof-of-concept study included 43 subjects, 60 to 90 years of age, with early AMD and impaired dark adaptation and/or impaired low luminance low contrast best corrected visual acuity (LLLC BCVA) in at least 1 eye, and with no other known ophthalmic pathologies to explain their condition. Subjects were randomized to receive placebo (11 subjects), 10 mg/m(2) (16 subjects), or 40 mg/m(2) (16 subjects) oral doses of QLT091001 on Day 0, Day 7, Day 14 and Day 15. Dark adaptation rates, glare recovery times, and LLLC BCVA were assessed at baseline, prior to dosing at visits on Day 7, Day 14, and Day 15, and at follow-up visits on Day 17, Day 28, and Day 42. Safety assessments included high luminance high contrast (HLHC) BCVA, ophthalmic examination, vital signs, electrocardiogram, laboratory testing and adverse events. Dark adaptation rates were assessed by determining the rod-cone break (RCB) times and glare recovery times in subjects after light exposure. A total of 14 subjects were defined as having impaired dark adaptation at baseline (defined as a RCB time of 9.0 minutes or longer). Analysis of the median change from baseline in RCB time showed that subjects treated with QLT091001 (n=10 for the 10 mg/m(2) and 40 mg/m(2) groups combined) had improved (shorter) RCB times at all 6 assessments compared to baseline (per protocol analysis). In comparison, impaired subjects treated with placebo (n=4) showed mixed results across assessments, with improvement in RCB time noted at only one assessment (per protocol analysis). For glare recovery, subjects treated with QLT091001 (10 mg/m(2) and 40 mg/m(2) combined; n=20) showed improved glare recovery times (median change from baseline) at 5 of 6 assessments while those treated with placebo (n=7) showed mixed results across assessments (per protocol analysis). Treatment with QLT091001 did not produce a clear treatment effect on LLLC BCVA using the protocol and procedures of this study. Treatment with QLT091001 demonstrated an acceptable safety profile and was well tolerated. The most common treatment-related adverse drug reaction was headache which was observed in the 40 mg/m(2) treatment group only (5 of 16 subjects). Two subjects withdrew from the study -- one due to a treatment-related adverse event (headache) and one due to SAEs that were not related to treatment. This randomized, single-masked, parallel-design, safety/proof-of-concept study was designed to include approximately 40 subjects with early AMD and impaired dark adaptation and/or impaired LLLC BCVA in at least 1 eye and with no other known ophthalmic pathologies to explain their condition. Subjects who met the eligibility criteria were randomized to receive one of the following oral doses of QLT091001 at Day 0, Day 7, Day 14 and Day 15: 0 (placebo), 10, or 40 mg/m(2) in a 2:3:3 randomization ratio. Dark adaptation rates, glare recovery times, and LLLC BCVA were assessed at screening and repeated prior to dosing on Day 0, Day 7, Day 14, and Day 15 and at follow up visits on Day 17, Day 28 and Day 42 to evaluate efficacy. Safety assessments (HLHC BCVA, ophthalmic examinations, vital signs, adverse events, concomitant medications) were conducted before the initial dose and at all study visits. Clinical chemistry, hematology, and urinalysis samples were collected at screening, prior to dosing on Day 7 and at follow-up visits on Day 17 and Day 42. The subset of subjects with impaired dark adaptation was identified as subjects having a RCB time of 9.0 minutes or longer at baseline. Subjects with an improvement in dark adaptation were those demonstrating a decrease in RCB time, corresponding to a faster adjustment time to see in dark environments. Improvement in a subject's glare recovery time was defined as an improvement in time taken to recover the ability to read a LLLC ETDRS vision chart after receiving a full-field glare source as compared to baseline. Subjects having impaired LLLC BCVA were defined as those having an LLLC BCVA that was at least 25 letters (about 5 lines) below their high luminance high contrast (HLHC) BCVA. The trial employed new clinical study endpoints that have not been commonly used in previous pharmaceutical trials. The placebo group was slightly younger on average (mean, 71.0 years) than the QLT091001 10 mg/m(2) (mean, 75.6 years) and 40 mg/m(2) (mean, 74.4 years) groups. All placebo subjects received all study treatments. Fifteen of 16 subjects (93.8%) in the 10 mg/m(2) group and 14 of 16 subjects (87.5%) in the 40 mg/m(2) group received all study treatments.
QLT Inc. Announces Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014
Oct 28 14
QLT Inc. announced earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported net loss of $4.9 million or $0.10 per share, compared with a loss of $7.3 million or $0.14 per share in the same period last year. The operating loss was $5.4 million compared to $7.5 million for the same period in 2013. The net $2.1 million decrease in operating losses is primarily due to lower R&D and restructuring expenses. Basic and diluted net loss per share from continuing operations was $0.10 compared to $0.15 in the same period in 2013. The decrease in loss per share is due to the same factors described above, as well as a $0.4 million income tax recovery recorded in connection with a decrease in the provision for uncertain tax positions due to the expiration of the statute of limitations. Loss from continuing operations before income taxes was $5,358,000 compared to $7,383,000 a year ago. Loss from continuing operations was $4,927,000 compared to $7,492,000 a year ago.
For the nine months, the company reported operating loss of $21,750,000 compared to $21,847,000 a year ago. Loss from continuing operations before income taxes was $20,163,000 compared to $19,704,000 a year ago. Loss from continuing operations was $19,969,000 compared to $20,138,000 a year ago. Net loss and comprehensive loss was $20,032,000 compared to $20,022,000 a year ago. Basic and diluted net loss per common share continuing operations was $0.39 compare to $0.40 a year ago. Net loss per common share was $0.39 compared to $0.39 a year ago.