Aridis Phar­ma­ceu­ti­cals’ mon­o­clon­al an­ti­body missed the bar in a Phase III test in ven­ti­la­tor-as­so­ci­at­ed pneu­mo­nia caused by the gram-pos­i­tive bac­te­ria S. au­reus, the com­pa­ny an­nounced Wednes­day. 

But Aridis is plan­ning for a sec­ond Phase III study any­way once it dis­cuss­es the find­ings with the FDA and the Eu­ro­pean Med­i­cines Agency. Ex­ecs blamed re­cruit­ment chal­lenges stem­ming from Covid-19 and Rus­sia’s in­va­sion of Ukraine for the miss, cut­ting their en­roll­ment tar­get in half.

“De­spite the lim­i­ta­tions of sam­ple size and lack of sta­tis­ti­cal sig­nif­i­cance in the pri­ma­ry end­point, we are pleased to see the clin­i­cal ben­e­fit trends across the study pop­u­la­tion,” Hasan Jafri, Aridis’ CMO, said in a state­ment.

Aridis’ an­ti­body, AR-301, com­bined with an­tibi­otics, failed to meet the pri­ma­ry end­point on in­creas­ing the clin­i­cal cure rate at day 21 com­pared to an­tibi­otics alone. The clin­i­cal cure rate at day 21 was 68.9% (42 of 61 pa­tients) for AR-301 plus an­tibi­otics ver­sus 57.6% (34 of 59) with just an­tibi­otics. The end­point was reach­ing a 10% or more im­prove­ment com­pared to the con­trol arm. While there was an 11.3% dif­fer­ence be­tween the arms, the re­sult was not sta­tis­ti­cal­ly sig­nif­i­cant (p=0.23).

Zoom­ing in­to sub­groups gives a brighter pic­ture — but still not in a sta­tis­ti­cal­ly sig­nif­i­cant way. In adults 65 years and old­er, Aridis notes an ab­solute ef­fi­ca­cy on day 21 of 34% (p=0.057) which in­creased to 38% on day 28 (p=0.025), large­ly be­cause an­tibi­otics are less ef­fec­tive for this group of pa­tients. A sim­i­lar find­ing was re­port­ed for me­thi­cillin-re­sis­tant S. au­reus (MR­SA) pa­tients — the ab­solute ef­fi­ca­cy was 28% high­er than an­tibi­otics alone due to the low­er ef­fi­ca­cy of an­tibi­otics in MR­SA pa­tients (p=0.774).

How­ev­er, Aridis claims bet­ter da­ta on sec­ondary end­points, in­clud­ing “trends in re­duc­tion” for du­ra­tion of hos­pi­tal­iza­tion, amount of time in the ICU and days on ven­ti­la­tion.

There were no se­ri­ous ad­verse events linked to the drug and none of the deaths in the study were deemed drug-re­lat­ed, the com­pa­ny says. The study en­rolled 120 pa­tients who had S. au­reus as the pre­dom­i­nant cause of pneu­mo­nia, down from the orig­i­nal goal of 240. Shares $ARDS tum­bled more than 30% to $0.84.

AR-301 tar­gets S. au­reus al­pha-tox­in, which is se­cret­ed by the bac­te­ria, with the hope of adding an ad­di­tion­al lay­er of de­fense.

This is not the on­ly one of Aridis’ an­ti­bod­ies for pneu­mo­nia to strug­gle. In 2019, the an­ti­body AR-105 failed to beat out a place­bo in treat­ing ven­ti­la­tor-as­so­ci­at­ed pneu­mo­nia caused by gram-neg­a­tive Pseudomonas aerug­i­nosa. And there was an im­bal­ance in deaths and se­ri­ous ad­verse events that left the ther­a­py with a worse safe­ty pro­file.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.