Clinical biopharmaceutical company Clearside Biomedical Inc. (CLSD:NASDAQ), which is focused on developing and providing treatments in order to restore and preserve vision for individuals with serious back of the eye diseases, today announced "positive safety results from Cohort 1 of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside's SCS Microinjector® in six patients (n=6) with neovascular age-related macular degeneration (wet AMD)."
The firm noted that the six subjects in Cohort 1, who were administered the initial lowest planned dose of 0.03 mg CLS-AX, successfully achieved all key primary endpoints in the study. Clearside advised that the drug was well tolerated in the trial and that patients in Cohort 1 demonstrated "no signs of inflammation, no vasculitis, no intraocular pressure (IOP) safety signals, no dispersion of drug into the vitreous or any other drug related adverse events."
The company stated that the OASIS' trial's Safety Monitoring Committee has looked closely at the results and has given the go ahead to proceed with Cohort 2. The firm mentioned that this subgroup would be given a stronger dosage of 0.1 mg CLS-AX starting in June 2021 and be studied for a period of four months.
Clearside Biomedical's Chief Medical Officer and Chief Development Officer Thomas A. Ciulla, M.D., MBA, commented, "We are very encouraged by the Cohort 1 results of the OASIS trial and we are immediately beginning Cohort 2 enrollment as planned…The initial data from Cohort 1 clearly achieved our safety and tolerability endpoints. While still early and recognizing there are a limited number of patients, we believe the Cohort 1 data supports our hypothesis that the combination of targeted and compartmentalized suprachoroidal delivery and the potent pan-VEGF attributes of axitinib may facilitate an effective treatment option for patients suffering from wet AMD."
The company indicated that the average age of the Cohort 1 patients was 82, all of whom were confirmed to have persistent active disease and had previously undergone numerous anti-VEGF injection treatments before participating in the trial.
Mark R. Barakat, M.D., director of research for Retinal Consultants of Arizona and clinical assistant professor at University of Arizona College of Medicine in Phoenix, remarked, "CLS-AX was well-tolerated and these initial results in this heavily treatment-experienced group of wet AMD patients are promising. I look forward to the continued clinical advancement of CLS-AX at the planned higher doses to further explore potential benefits in visual acuity, ocular anatomy and durability."
The company explained that the OASIS study is a Phase 1/2a single dose-escalation trial designed to evaluate the safety and tolerability of CLS-AX at increasing dosage levels in patients diagnosed with wet AMD. The firm noted that the drug is administered via suprachoroidal injection utilizing Clearside's SCS Microinjector®.
Clearside stated, "Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity and that it believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade."
Clearside is based in Alpharetta, Ga., and concentrates its efforts on the development of treatments that preserve and restore in those with serious back of the eye diseases. The firm stated that "its proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs."
Clearside Biomedical began the day with a market cap of around $173.9 million with approximately 57.6 million shares outstanding and a short interest of about 1.4%. CLSD shares opened more than 30% higher today at $3.999 (+$0.979, +32.42%) over yesterday's $3.02 closing price and reached a new 52-week high this morning of $4.70. The stock has traded today between $3.6167 and $4.80 per share and is currently trading at $4.16 (+$1.14, +37.78%).[NLINSERT]
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