Global Roundup: Abivax Eyes Phase III Following Positive UC Data
27 May 2021
First in ClassVaccineSmall molecular drugEmergency Use Authorization
France’s Abivax SA posted positive Phase IIb data from an ulcerative colitis trial assessing ABX464, a small molecule for once-daily administration with a first-in-class mechanism of action. In the study, 254 patients with moderate to severe ulcerative colitis (UC) were treated with ABX464.
Top-line data showed significant clinical efficacy in the overall patient population on primary and key secondary endpoints and a good safety profile of ABX464, the company said. After 48 weeks of maintenance treatment with ABX464, preliminary data from the first 51 patients showed further increased and durable clinical and endoscopic efficacy. Based on these results, a Phase III study is expected to begin by the end of the year.
“The Phase IIb results demonstrate the potential of ABX464 to become a game changer for the treatment of ulcerative colitis patients in need of new therapeutic management options. Based on these data, we are now moving forward as quickly as possible with our phase 3 plan in ulcerative colitis as well as Phase IIb/III in Crohn’s disease to bring ABX464 to the many patients suffering from inflammatory bowel disease,” Hartmut J. Ehrlich, M.D., chief executive officer of Abivax said in a statement.
Elsewhere around the globe:
Elicera Therapeutics – Sweden-based Elicera raised SEK 52 million from a new share issue ahead of its planned listing on Nasdaq First North Growth Market.
CanSino Biologics – China’s CanSino announced its Recombinant Novel Coronavirus Vaccine, (Adenovirus Type 5 Vector), which is under the trade name Convidecia, has been granted a Good Manufacturing Practice certificate by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI). The EU GMP certification is required to import COVID-19 vaccines into the European Union and is regarded as a recognition of leading industry standards by many authorities outside of the EU. This certification signifies CanSinoBIO’s readiness to enter more markets in Europe and globally, the company said. CanSinoBIO opened a new vaccine production site in Tianjin, China, with the expectation to produce over 200 million doses of Convidecia annually. In March, CanSinoBIO initiated a Phase I clinical trial of an inhaled version of Convidecia immediately after receiving the approval from the National Medical Products Administration of China.
RDIF – The Russian Direct Investment Fund and Panacea Biotec, a leading vaccine and pharmaceutical producer in India, announced the launch of production of the Russian Sputnik V vaccine against coronavirus. The first batch produced at Panacea Biotech’s facilities at Baddi will be shipped to the Gamaleya Center in Moscow for quality control. Full-scale production of the vaccine is due to start this summer. Sputnik V was registered in India under the emergency use authorization procedure on April 12. RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V.
MaaT Pharma – France’s Maat Pharma announced final results from the Phase I/II ODYSSEE clinical trial have been published in the journal, Nature Communications. The data demonstrated that the company’s initial product candidate, MaaT011, an autologous fecal microbiota transfer treatment, was safe and effective in fully restoring the gut microbiota in the 20 per-protocol analyses set of acute myeloid leukemia (AML) patients. The MaaT011 treatment showed short- and long-term signs of positive clinical outcomes including the reduction of both intestinal inflammation and gut carriage of antibiotic resistance genes, the company said. Follow-up results from the trial also showed that only 17% of the AML patients who received the MaaT011 intervention and allogeneic hematopoietic stem cell transplantation developed gastrointestinal- graft -versus-host disease. The overall survival rate in the trial was 92% at six months and 72% at two years.
Vetter – Germany-based Vetter, a contract development and manufacturing organization (CDMO), has won the Axia Best Managed Companies Award for the second year in a row. The company was selected for its “clear vision, innovative approaches, sustainable management culture and sound financial management.”
Adocia – France’s Adocia filed patents filed for the treatment of metabolic diseases including obesity, NASH (Non-Alcoholic Steato-Hepatitis), type 2 diabetes and neurodegenerative disorders. These patents relate to combinations of short-acting hormones administered via pump. First preclinical results obtained in obese mice population by a combination of glucagon-exenatide (BioChaperone® GluExe) show a weight loss of 25% versus 15% with exenatide alone after 14 days of treatment1. A second combination of pramlintide and exenatide (PramExe), currently in development, also presents promising properties. The pumps used are those already marketed for insulin therapy, and in particular patch-pumps, which are easy to use and suitable for this purpose. The user can adjust the maximal tolerable dose and therefore optimize the benefit/risk balance, the company said.
Medtronic plc – Ireland-based Medtronic announced it secured a CE Mark for expanded functionality of the company's InPen smart2 insulin pen for multiple daily injections (MDI). The company also announced CE Mark for its Guardian 4 sensor3, which requires no fingersticks1 for calibration or diabetes treatment decisions. The CE Mark allows this next-generation sensor to be integrated with either the MiniMed 780G insulin pump system or InPen, or for stand-alone continuous glucose monitoring (CGM) use.
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