A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition such as high blood pressure, type 2 diabetes or high cholesterol. Tirzepatide has been branded Zepbound for the new indication and will be used in addition to diet and exercise. Phase III data from the Surmount-2 trial, reported in May, showed overweight and obese type 2 diabetes patients receiving the highest dose of tirzepatide lost up to 34.4 pounds.
US FTC delivers on Orange Book threat
Carrying through on a policy it adopted a few months ago to crack down on “improper” FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice this week that it’s challenging several of their listed patents through the FDA’s regulatory dispute process. But it may not stop there, the FTC said. Altogether, the agency is challenging more than 100 patents, including many related to the device component of combination products. Yet industry experts say device patents should be listed, as they help generic companies assess the litigation risks they may face in developing a copy of a combination product.
Durect drops on mixed phase IIb data in alcohol-associated hepatitis
Shares of Durect Corp. (NASDAQ:DRXX) were down 75% at midday on a phase IIb readout for larsucosterol in patients with severe alcohol-associated hepatitis. While the study missed the primary endpoint, failing to show a statistically significant numerical improvement of mortality or transplant at 90 days, Durect pointed to “compelling” results on reduction of mortality in 90 days, a key secondary endpoint, and announced plans to consult the U.S. FDA for a potentially registrational phase III study.
Lumos phase II PK/PD data promising in pediatric growth hormone deficiency
Lumos Pharma Inc. disclosed that top-line data from the Oragrowth210 dose-finding trial and the Oragrowth212 pharmacokinetic/pharmacodynamic (PK/PD) trial, both phase II, testing LUM-201 in pediatric growth hormone deficiency, show that they met all primary and secondary endpoints. Shares of the Austin, Texas-based firm (NASDAQ:LUMO) were trading midday at $4.09, up 45 cents, or 12%. The compound is an oral growth hormone-stimulating small molecule.
Getting its bear-ings: Orsobio raises a $60M series A
Orsobio Inc., already in the clinic with three candidates, has completed its $60 million series A financing. The company has now raised $97 million in capital. Orsobio’s four-program pipeline is focused on obesity and associated metabolic disorders. The severe disorders include type 2 diabetes, nonalcoholic steatohepatitis and severe dyslipidemias. The series A financing was co-led by Longitude Capital and Enavate Sciences. Eli Lilly and Co. is a new investor. Its existing investors include Samsara Biocapital and Nuevabio, an affiliate of the founders. Orsobio was founded in 2020. The company name was inspired by the metabolic adaptability of bears, which is orso in Italian, that allows them to avoid serious sequelae despite living in extreme weather conditions.
GC Biopharma files for approval of first homegrown anthrax vaccine
South Korea may soon gain its first domestically developed anthrax vaccine by GC Biopharma Corp., with the Korean biotech having filed Nov. 1 with the MFDS for approval of its novel recombinant protein anthrax vaccine called GC-1109. If approved, GC-1109 would become the world’s first recombinant anthrax vaccine, the Yonging, Gyeonggi-do-based plasma protein and vaccine manufacturer said. “In order to prepare against potential bioterrorism and consequent national crisis, GC Biopharma, under the research project supported by [the Korea Disease Control and Prevention Agency] KDCA, has been working on developing a recombinant vaccine for anthrax since 2002,” the company wrote in a statement.
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