It’s been a busy week for biotech updates, and there’s plenty to discuss (look forward to) throughout the remainder of 2016. Here are a few of the update highlights, and a look at what impact they might have on the companies in question.
Aclaris Therapeutics Inc (NASDAQ:ACRS)
First up, Aclaris. Aclaris has a primary focus on dermatology, and its lead candidate is A-101. The company is investigating it in two separate indications, seborrheic keratosis and common warts. For those not familiar with the former indication, it’s a pretty common non-cancerous growth that forms on the skin, with a waxy, brown appearance. The treatment is a topical gel formulation of hydrogen peroxide, intended for clinician issue but designed for domestic administration. Aclaris reported its 2015 FY and 4Q financials at market close on Wednesday, and alongside the report, gave us an update as to the progress of both drugs along the clinical development pathway.
The common wart indication is farther along than the SK – currently in a phase III – and is expected to complete during the third quarter of this year. In line with this completion, topline (also set to be released during 3Q) is a near term milestone and potential upside catalyst. We’re looking at an identical timeframe for the SR indication, but this time in a phase II trial, scheduled for completion mid 3Q and topline across the same three-month period.
Inotek Pharmaceuticals Corp (NASDAQ:ITEK)
Inotek also just gave us an update detailing its FY 2015 and Q4 financials, and alongside the numbers, offered up a timeframe on its lead clinical candidate, Trabodenoson. The drug is an open-angle glaucoma indication, and is currently under investigation as part of a phase III that Inotek kicked off in October last year. The drug is designed to treat the intraocular pressure associated with glaucoma, while avoiding the current safety and tolerability issues that are come as part of the currently available SOC, which is a topical formulation of an old, established compound.
Top line is scheduled for release during the fourth quarter of 2016, and if previous data is anything to go by, Inotek has a decent chance of getting this one through to an NDA submission. The company has had a pretty rough start to the year (not necessarily attributable to its own performance – more likely as a result of wider market weakness), and market s will be looking to the topline release from this glaucoma trial as a potential reversal catalyst. Keep an eye out for a mid stage update, likely set for the beginning of the third quarter.
Otonomy Inc (NASDAQ:OTIC)
Finally. Otonomy. We’ve covered this company a few times before at Market Exclusive, so some readers might already be familiar with its pipeline. For those not yet so, its primary focus is an inner ear disorder called Ménière’s disease. It primarily affects men and women aged 45 and over, and involves symptoms that include vertigo, dizziness and – eventually – hearing loss. Otonomy just updated us as to the state of development of its lead candidate in the Ménière’s indication, reporting the initiation of two concurrent phase IIIs in numerous centers across the US. If the company can replicate phase II data in these expanded trials, it could get an NDA with the FDA before the end of next year. Before then, however, we’ve got two major milestones that could potentially inject some upside momentum into Otonomy’s market capitalization. First, an interim data dump that should hit before the end of this year. The data will offer mid-stage insight into how the company’s candidate – OTO-104 – is performing in the pivotals. Post interim, topline is scheduled for mid to late 2017.
Just as with Inotek, Otonomy has had a pretty rough start to 2016. The company is down 50% on its 2016 open, and shareholders will be looking to the aforementioned releases to offer up some reprieve going forward. One to watch.