New data from two phase II studies from two companies showed progress in their respective Parkinson’s disease (PD) programs. Sage Therapeutics Inc.’s open-label phase II study of Sage-718, an oral, positive allosteric modulator of the NMDA receptor, demonstrated improved performance in cognitive tests of executive functioning, learning and memory in those with mild cognitive impairment due to PD. Anavex Life Sciences Corp.’s phase II study of ANAVEX2-73 (blarcamesine), an oral sigma-1 receptor activator, showed clinically meaningful, dose-dependent and statistically significant cognitive improvements in its participants. The data for both therapies were presented on opening day, March 15, at the AD/PD 2022 Advances in Science & Therapy International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, being held in Barcelona until March 20.

KOLs talk up Tiziana’s intranasal MS therapy; second patient authorized

During a conference call with key opinion leaders, Tiziana Life Sciences Inc. provided details on stock-boosting news disclosed March 10 with foralumab, a fully human anti-CD3 monoclonal antibody given intranasally for secondary progressive multiple sclerosis. Microglial activation was inhibited, as shown by a positron emission tomography scan, and pro-inflammatory cytokines were down-regulated. Based on the findings at Harvard Medical School’s Brigham and Women’s Hospital, the FDA has allowed a second patient to get the drug under a single-patient expanded access IND.

Hansoh wins China’s first approval for an anti-CD19 antibody to treat neuromyelitis optica spectrum disorders

Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.

Big pharma puts clinical trials on hold in Russia and Ukraine as war continues

Big pharma sponsors of clinical trials in Ukraine are putting studies on hold in Russia, Ukraine and Belarus as the conflict continues into its third week. Pharma firms Merck & Co. Inc., Astrazeneca plc, Roche Holding AG, Johnson & Johnson, Bristol Myers Squibb Co., Pfizer and Eli Lilly and Co. all have reported trials that have been affected.

Beigene gets first reimbursement in Australia for Brukinsa in mantle cell lymphoma

Australians with mantle cell lymphoma (MCL) will now have subsidized access to Beigene Ltd.’s BTK inhibitor, Brukinsa (zanubrutinib), as of March 1, marking the company’s first drug to be listed on Australia’s Prescription Benefits Scheme (PBS). Australia’s Pharmaceutical Benefit Advisory Committee (PBAC) recommended Brukinsa for reimbursement in MCL and it was listed on the PBS in March 2022. Although Beigene submitted a second application for Waldenstrom’s macroglobulinemia (WM) at the same time, the PBAC did not recommend it for approval for the WM indication. For WM, the company received “the nicest no that we could have received,” Arthur Alston, Beigene’s Asia Pacific head of medical affairs, told BioWorld. PBAC Chair Andrew Wilson told the company that the value proposition needed improvement.

Everest Medical expands IgAN deal with Calliditas to include South Korea

Everest Medicines Ltd. has acquired rights to develop and commercialize Nefecon (budesonide) for the treatment of primary IgA nephropathy (IgAN) in South Korea from Calliditas Therapeutics AB. Everest paid $3 million up front to Calliditas at the signing of the agreement. The companies did not disclose further financial details. “Nefecon could potentially follow Trodelvy (sacituzumab govitecan) to become our company’s second commercialized product in South Korea,” Kerry Blanchard, CEO at Everest Medicines, told BioWorld.

Activating activators is strategy against apoptosis defectors

By combining an activator of the pro-apoptotic protein BAX with an inhibitor of the anti-apoptotic protein BCL-XL, researchers at Albert Einstein College of Medicine have been able to overcome resistance to apoptosis in both a wide range of cell lines and animal studies. The team reported its findings in the March 7, 2022, issue of Nature Communications.

HELP looks to the future with PREVENT bill

The bipartisan PREVENT Pandemics Act, which seeks to put into U.S. law many of the lessons learned from the COVID-19 pandemic, marked its first milestone today, with the Senate Health, Education, Labor and Pensions (HELP) Committee sending it to the full Senate with a do-pass recommendation on a 20-2 vote. “People are getting back to their lives, but we all know how long of a road it took to get here,” HELP Chair Patty Murray (D-Wash.) said in opening the markup of the package that’s intended to ensure the U.S. is better prepared for the next pandemic when it comes to testing, personal protective equipment, medical equipment, drugs and vaccines. A lot of that preparation will come down to access to and sharing of better data.

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Abbvie, Agile, Allarity, Almirall, Alzecure, Anaptysbio, Anavex Life Sciences, APR Applied Pharma Research, Araclon, Arrowhead, Ascentage, Ascletis, Astellas, Beigene, Biogen, Biomed X Institute, Blackstone Life Sciences, Coherus, Eclipsebio, Eisai, ENA Respiratory, Enochian, Epizyme, Exelixis, Eyenovia, Gadeta, Gain, GTP Bioways, Iaso, Ideaya, Immunomic, Impact, Imugene, Incyte, Innovation, Inversago, Junshi, Kahr, Kairos, Krystal, Kukbo, Linkinvax, Maia, Medison, Merck, Merck KGaA, Myrtelle, Nervgen, Nosopharm, Nova Mentis, Orasis, Ovid, Passage, PDS, Pepgen, Periphagen, Pharmajet, Qualigen, Quoin, Quralis, Redhill, Relief, Revelation, Reveragen, Sage, Sanofi, Santhera, Sunshine, Tevogen, Trevi, Virpax, Wesana Health, Windtree, Wugen