The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir). Litfulo, a once-daily oral JAK3 kinase inhibitor and TEC kinase family inhibitor, is the first and only treatment for adolescents aged 12 years and over, according to Pfizer, so could capture the “nearly 20%” of people who are diagnosed before the age of 18. By contrast, Eli Lilly and Co.’s once-daily JAK inhibitor pill Olumiant (baricitinib), which was approved in June 2022, only addresses the adult form of the condition, as does late-stage competitor CTP-543 (deuruxolitinib, Concert Pharmaceuticals Inc.).
Avalo falls on phase II miss in asthma
Shares of Avalo Therapeutics Inc. (NASDAQ:AVTX) were down 86% at midday on news that its phase II Peak study testing AVTX-002 in patients with poorly controlled non-eosinophilic asthma missed its primary endpoint, as measured by the reduction of asthma-related events. The company, however, pointed to a positive trend seen in a subpopulation of patients with elevated baseline levels of LIGHT, an immunoregulatory cytokine. AVTX-002, or quisovalimab, is a monoclonal antibody targeting LIGHT that has also been tested in acute respiratory distress syndrome in COVID-19 patients and in Crohn’s disease.
Menin inhibitor from Biomea yields phase I/II results at ADA meeting
Biomea Fusion Inc. rolled out new clinical data from the first two cohorts of patients with type 2 diabetes (T2D) enrolled in the phase II portion of its ongoing phase I/II study called Covalent-111 of BMF-219, the company’s oral covalent menin inhibitor. The 100-mg cohort 3 turned up a 90% response rate and 70% maintained or improved time in normal glucose range while off treatment. Redwood City, Calif.-based Biomea offered the findings during the American Diabetes Association scientific sessions in San Diego. Menin is a scaffold protein with multiple interaction partners, and BMF-219 is in development in oncology as well as T2D. Shares (NASDAQ:BMEA) were trading midday at $25.23, down $5.44, or 17.8%.
Three is not a charm: Fibrogen fails again
A tough spring has settled into a cruel summer for Fibrogen Inc. as the company has stumbled for the third time in three months. The newest problem is top-line results showing the phase III study of pamrevlumab for treating idiopathic pulmonary fibrosis missed its primary endpoint. In the last two months, phase III failures include pamrevlumab for non-ambulatory patients with Duchenne muscular dystrophy and roxadustat for anemia caused by myelodysplastic syndromes. A phase III readout of pamrevlumab for pancreatic cancer is expected in the next year. The bottom fell out of the company’s stock (NASDAQ:FGEN) at midday, with shares down 82% to about $2.80 each.
US FTC no longer alone in trying to stop Amgen-Horizon deal
The U.S. FTC gained six allies in its unprecedented effort to stop Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. The attorneys general for California, Illinois, Minnesota, New York, Washington and Wisconsin joined the FTC in signing onto an amended complaint filed under seal last week in the U.S. District Court for the Northern District of Illinois. When the FTC announced the original suit last month, it acknowledged there was no commercial overlap between the two companies and that its suit was breaking new ground in biopharma antitrust challenges. California Attorney General Rob Bonta welcomed the FTC’s new direction, saying his office has called on the federal government for years to enforce competition laws more aggressively.
Shionogi to acquire Qpex for $140M to expand antimicrobial pipeline
Shionogi & Co. Ltd.’s U.S. subsidiary Shinogi Inc. will acquire San Diego-based Qpex Biopharma Inc. in a deal worth up to $140 million that expands Shionogi’s pipeline of infectious disease agents and also adds to Brii Biosciences Ltd.’s pipeline. Under terms of the deal, Shionogi, of Osaka, Japan, will pay Qpex $100 million up front, and up to an additional $40 million in regulatory and development milestones. Following the close of the acquisition, Qpex will become part of Shionogi, and the two companies will work together to address life-threatening bacterial infections.
Savvy at in-licensings, biopharma Edding Group files for Hong Kong IPO
Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market. Nominal share value was listed at US$0.00002 per share, according to the regulatory filing, although the number of shares was not disclosed. Initial authorized share capital was $50,000, divided into 500 million shares with a par value of $0.0001, the firm said. Edding Group – founded in 2001 by CEO Ni Xin – grew to prominence in China’s biopharma market after striking key licensing agreements with multinational companies and obtaining marketing authorization holder rights for original drugs like Vancocin (vancomycin) and Ceclor (cefaclor), both from Eli Lilly and Co.
2023 clinical data compare similarly to last year
Clinical data in the first five months of 2023 is remarkably consistent to last year. BioWorld reported on 1,449 drugs in phase I-III this year, compared to 1,452 in the same time period in 2022. Numbers are down 12.13% from 1,649 in 2021, but up from 2020’s 1,419 and 2019’s 1,173. By phase, clinical data so far in 2023 consist of: 590 items involving phase I data; 490 covering phase II; and 369 for phase III. Based on indication, therapeutic updates for cancer lead by far, at about twice as many as the next highest indication.