With the first-ever human data on the efficacy and safety of aldehyde-trapping in hand from a phase IIa trial against allergic conjunctivitis (AC), Aldeyra Therapeutics Inc. said it will wait to consult U.S. regulators until the next quarter when outcomes from another study testing the same compound, NS2, in non-infectious anterior uveitis (AU) become available.
It's too early to say whether Cara Therapeutics Inc.'s delay of its phase III adaptive pivotal trial with intravenous (I.V.) CR845 for postoperative pain will provide an edge for competitor Trevena Inc. with oliceridine (TRV130), but the FDA's protocol hold was triggered by a pre-specified, conservative measure of previously seen sodium levels and could be dispatched within a few months.
So far, the data with allogeneic chimeric antigen receptor (CAR) T-cell therapies say, "liquid tumors yes, solid tumors not yet," Precision Bioscience Inc.'s Chief Scientific Officer Derek Jantz told BioWorld Today, but his genome-editing firm looks to make "significant improvements to the status quo" in the potential $1.6 billion-plus, six-target cancer deal with Baxalta Inc. for allogeneic therapies.
Impressively partnered Rani Therapeutics Inc.'s latest round of "more than $50 million" brings to greater than $70 million the amount of cash raised thus far by the firm, which "could be in the clinic in the second half of next year with a molecule that we might develop on our own," CEO Mir Imran told BioWorld Today.
The candidate that may become not only the first-ever topical nitric-oxide (NO) macromolecule approved but also the first new chemical entity for acne in 20 years took one more step toward potential marketing as Novan Inc. kicked off its phase III program with topical gel SB204.
Chimerix Inc. CEO Michelle Berrey assured investors of "some ways for us to skin this cat a little more quickly," as the company probes the intriguing efficacy of brincidofovir – often shorthanded to "brinci" – against BK virus, although Wall Street meanwhile clipped shares on word that two phase III trials with the oral nucleotide analog in kidney transplant are stopping.
The principal investigator for the original proof-of-concept study with just-approved epilepsy drug Briviact (brivaracetam) told BioWorld Today she's campaigning to get the FDA to cut the "add-on" description for such therapies, because there is "no indication that a drug that works as an add-on would not work by itself," and the tag is confusing to everyone – including payers.
Spinning a company out of big pharma is "easier said than done," Corvidia Therapeutics Inc. CEO and co-founder Michael Davidson told BioWorld Today. The project needs a worthy asset, the right investors and researchers familiar with the drug. "In this case, we got all three aligned, but it took a while – over a year – to make it happen," he said.
Echoing last year's hoopla surrounding Inotek Pharmaceuticals Corp.'s progress with trabodenoson, Wall Street cheered the FDA blessing on Ocular Therapeutix Inc.'s phase III plan with OTX-TP (travoprost), a sustained-release punctal plug for glaucoma and ocular hypertension – a program minus any timolol comparator arm.
