Cor­bus Phar­ma­ceu­ti­cals’ plans to po­si­tion lenaba­sum as a pipeline-in-a-prod­uct aren’t go­ing so well.

Af­ter shelv­ing a pro­gram in scle­ro­der­ma, the Nor­wood, MA-based biotech has re­vealed that its lead can­di­date failed both the pri­ma­ry and sec­ondary end­points in an­oth­er Phase III tri­al.

Lenaba­sum failed to show a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in to­tal im­prove­ment com­pared with place­bo in treat­ing der­mato­myosi­tis, a rare dis­ease that caus­es mus­cle in­flam­ma­tion and skin rash, the com­pa­ny said Thurs­day. The news sent Cor­bus’ $CRBP stock spi­ral­ing around 30% ear­ly Thurs­day morn­ing.

Par­tic­i­pants in the study re­ceived one of two dos­es of lenaba­sum (20 mg or 5 mg) twice a day, or a place­bo, all in ad­di­tion to back­ground treat­ments. At week 28, those in the 20 mg group saw a mean to­tal im­prove­ment score (TIS) of 28.3, ver­sus 26.7 in the place­bo group. How­ev­er, the p-val­ue came in at 0.1965, which is far over the gold­en 0.05 num­ber of­ten used in drug tri­als to mea­sure sta­tis­ti­cal sig­nif­i­cance.

“We are dis­ap­point­ed that the tri­al did not meet the pri­ma­ry end­point of TIS at Week 28,” CMO and head of re­search Bar­bara White said in a state­ment.

Lenaba­sum is a small mol­e­cule that binds to and ac­ti­vates CB2, which is ex­pressed on ac­ti­vat­ed im­mune cells. The Phase III study, dubbed DE­TER­MINE, en­rolled pa­tients with two types of der­mato­myosi­tis: those who have both mus­cle weak­ness and skin in­volve­ment, and those with skin in­volve­ment but no sig­nif­i­cant mus­cle weak­ness.

In an at­tempt to look on the bright side, Cor­bus said high­er TIS scores were seen in par­tic­i­pants who had mus­cle weak­ness and were treat­ed with two 20 mg dos­es com­pared to place­bo, with a nom­i­nal p-val­ue of 0.0302. And pa­tients with skin symp­toms but no mus­cle weak­ness showed greater im­prove­ments on the Cu­ta­neous Der­mato­myosi­tis Ac­tiv­i­ty and Sever­i­ty In­dex (CDASI), which mea­sures in­flam­ma­to­ry skin in­volve­ment, with a nom­i­nal p-val­ue of 0.0166.

How­ev­er, the drug flopped on an­oth­er sec­ondary end­point: ef­fect on lung func­tion. No sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence was seen at week 28 com­pared to the con­trol group, ac­cord­ing to Cor­bus.

CEO Yu­val Co­hen told End­points News that the com­pa­ny will have a dis­cus­sion with reg­u­la­tors, and if the next step is to con­duct an­oth­er study, they’ll dis­cuss which pa­tients and which end­points to fo­cus on.

“While, again, we did not hit on the pri­ma­ry, it’s the sec­ond time that we’re see­ing signs of what we think is clear: clin­i­cal ac­tiv­i­ty,” he said. “What we’re al­so wait­ing for are the bio­mark­er da­ta from skin biop­sies. In our Phase II, the bio­mark­er da­ta was very en­cour­ag­ing.”

Lenaba­sum is the com­pa­ny’s on­ly clin­i­cal can­di­date, ac­cord­ing to their web­site. It has oth­er CB2 ag­o­nists in the works for sol­id tu­mors, as well as CB1 in­verse ag­o­nists for me­tab­o­lism dis­eases and two mon­o­clon­al an­ti­bod­ies for sol­id tu­mors and fi­bro­sis.

Cor­bus spent years build­ing up in­vestors’ hope in lenaba­sum. But back in Sep­tem­ber, the drug failed a Phase III study for a rare au­toim­mune con­di­tion called scle­ro­der­ma. The fol­low­ing month, it an­nounced it would shave its work­force by 54%. The com­pa­ny, which once had hopes for lenaba­sum as a pipeline in a prod­uct, said it would re­fo­cus on pro­grams in der­mato­myosi­tis and sys­temic lu­pus ery­the­mato­sus, and its pre­clin­i­cal can­di­dates.

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.