UK-based biotech Verona Phar­ma said Tues­day morn­ing that its drug, en­sifen­trine, passed its sec­ond late-stage tri­al for the com­mon lung dis­ease COPD.

In Au­gust, Verona re­port­ed the drug suc­ceed­ed in the first of its two Phase III tri­als. Now, Verona will pack­age to­geth­er the new tri­al da­ta in its ap­proval fil­ing to the FDA, which the biotech said will come in the first half of next year.

Verona’s stock $VR­NA opened around 30% above its last close, jump­ing from un­der $14 to near­ly $17.

The sec­ond tri­al’s de­sign is sim­i­lar to the first — 500 pa­tients got en­sifen­trine as their COPD main­te­nance treat­ment, 300 got place­bo and all were fol­lowed for 24 weeks — but in the sec­ond tri­al, 400 pa­tients were fol­lowed for an ad­di­tion­al 24 weeks for long-term safe­ty da­ta. As in the first tri­al, the ma­jor­i­ty of pa­tients en­rolled were al­ready re­ceiv­ing some form of COPD treat­ment; around two-thirds were on a long-act­ing in­haler as back­ground ther­a­py, while just over 20% got in­haled cor­ti­cos­teroids on top of that.

Pa­tients on Verona’s drug best­ed those on place­bo in a breath­ing test that mea­sures the abil­i­ty to force­ful­ly breathe out — the pri­ma­ry end­point of the study — at week 12, and those re­sults were con­sis­tent re­gard­less of back­ground med­ica­tion, Verona said.

Chris Mar­tin

The study al­so met a num­ber of sec­ondary end­points look­ing at lung func­tion, dai­ly COPD symp­toms and over­all qual­i­ty of life. The on­ly point on which en­sifen­trine nar­row­ly missed sta­tis­ti­cal sig­nif­i­cance was in re­duc­ing the rate of mod­er­ate to se­vere COPD ex­ac­er­ba­tions. Here, pa­tients in the treat­ment arm had a 36% re­duc­tion in rate of ex­ac­er­ba­tions over 24 weeks com­pared to place­bo, good for a p-val­ue of 0.0505.

Verona’s drug, if ap­proved, would in­tro­duce a new class of COPD ther­a­pies, and SVP of com­mer­cial Chris Mar­tin not­ed Verona be­lieves en­sifen­trine “has the po­ten­tial based on the da­ta to be priced at a pre­mi­um ver­sus the cur­rent neb­u­lised prod­ucts.” Verona is al­so test­ing the drug, which is its on­ly can­di­date, in mid-stage stud­ies in cys­tic fi­bro­sis and asth­ma.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.