QLT Inc. (QLTI) provided an update on its synthetic oral retinoid program. Apart from the update, the biotechnology company announced that it was reviewing its strategic options to increase efficiencies. Investors reacted positively to the news.
QLT, based in Canada, announced that it has started recruiting patients for enrollment in a phase IIa proof-of-concept study on its pipeline candidate QLT091001 in patients (aged above 60 years) with impaired dark adaptation (IDA), an eye disorder that worsens with age. The multi-center, placebo-controlled study intends to evaluate the safety and efficacy of QLT091001 on IDA time, glare recovery time and impaired low luminance low contrast best corrected visual acuity. QLT intends to begin dosing patients in the study by Mar 31, 2014.
QLT further announced that it is close to finalizing the protocol for a pivotal study on QLT091001 for treating inherited retinal disease such as leber congenital amaurosis (:LCA) and retinitis pigmentosa (RP) due to mutations in the LRAT and RPE65 genes. This follows discussions with the U.S. Food and Drug Administration (:FDA) and the European Medicines Agency (:EMA). QLT intends to provide a final guidance on the development plan of the candidate in both the above orphan indications before Mar 31, 2014 after receiving final feedback from the EMA.
Furthermore, the biotechnology company said that it has initiated a compassionate use program for QLT091001. The program is designed to make QLT091001 available to patients evaluated in the phase Ib study on the candidate for treating LCA and RP. Moreover, the company announced that it intends to launch a patient registry along with advancing the orphan program in LCA and RP into pivotal trials. The patient registry is aimed mainly for identification of patient status besides following progression of the disease to arrive at its natural history.
QLT also said that it intends to complete final analysis of the data from the retreatment study on QLT091001 in the LCA and RP indications by the first quarter of 2014. QLT has completed dosing patients in the study, initiated in 2012. Follow-up of subjects is underway. The study, involving patients in the completed phase Ib study on the candidate, is evaluating the safety, efficacy and tolerability of repeat dosing cycles of the candidate administered over a week.
QLT carries a Zacks Rank #3 (Hold). Stocks such as Vanda Pharmaceuticals, Inc. (VNDA), Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals (JAZZ) appear to be more attractive with a Zacks Rank #1 (Strong Buy).
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