Opthea (ASX: OPT) shares have more than doubled this morning after announcing its Phase IIb clinical trial was a success.
The 366-patient study tested its OPT-302 drug, which battles wet (neovascular) age-related macular degeneration (AMD) against Lucentis monotherapy. Patients that received OPT gained 14.2 letters of vision, over 30 per cent of the baseline set (10.8).
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Opthea boss Megan Baldwin told a conference call the results were exciting.
“Today’s announcement is a tremendous outcome for Opthea and provides a new hope of a new approach for patients with AMD,” she declared.
“The team is delighted to report it met the primary end points of demonstrating statistically significant gains. These results position it well ahead in the competitive landscape of companies developing other treatments.”
Optometrist Pravin Dugel joined the call and said it was the first study he knew that improved the efficacy of eyes with AMD. He noted the lift in letters read could make all the difference between being able to do things such as read, drive and distinguish faces.
“(If) you’re looking for a drug that can provide better vision, we have something we can give you that can help you,” he said. “From my perspective that’s a fantastic success, it’s a monumental achievement.
“Would I use that? Certainly I would.”
This is the third clinical study OPT-302 has passed and now Opthea wants to take it forward. Baldwin told Stockhead: “We’re encouraged to move it [OPT-302] forward for the benefit of patients.”
However the next step was Phase III studies.
“We’re designing [Phase III] with the input of US regulators, but we can move forward knowing we have good solid data…and sufficient capital to be undertaking these activities,” she said.
Opthea shares have increased by over 100 per cent this morning.
In other ASX small cap news today…
Althea (ASX: AGH) has told shareholders this morning July was a record-breaking month. It treated 334 new patients at a rate of 14.5 per day and it has treated a total of 1,523. The company credited the result to broader activity in the cannabis market. It also announced it had entered an arrangement with private cannabis company Tetra to be its education and distribution partner in Australia. Shares jumped 8 per cent at market open.
Paradigm Biopharmaceuticals (ASX: PAR) has filed its first submission to the US FDA so it can begin trialling its anti-osteoarthritis drug Zilosul. The company anticipates among its patients former NFL players. It also expects to be in pre-IND meetings with its clinical trial drugs next quarter.
In capital raisings this morning Novita Healthcare (ASX: NHL) announced it will raise $2 million in a rights issue and Botanix Pharmaceuticals (ASX: BOT) declared it had raised $38.2 million of the $40 million it was targeting.