Intriguing Science
This week, this article published on the 16 October 2024 in Nature by Thomas Hoeig-Gensen and other researchers caught our attention: they developed a glucose-sensitive insulin that adjusts it’s bioactivity to glycemia (Hoeg-Jensen, 2024). Are they paving the road for self-regulating insulin? We hope so for patients with diabetes.
Global News
Novavax announced that the FDA placed a clinical hold on its Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The hold follows a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single participant in the CIC Phase 2 trial. Novavax press release.
After several setbacks, Sage Therapeutics announced an additional reduction of its R+D team by 55% and other functions including senior management. Sage press release.
European Medicine Agency
The EMA’s Committee for Medicinal Products for Human Use (CHMP) held its monthly meeting from October 14-17, 2024. Here are the key takeaways:
- Alhemo (concizumab, Novo Nordisk) received a positive opinion for the treatment of bleeding in patients with hemophilia A or B.
- Fluad (surface antigen, inactivated, adjuvanted, CSL Seqirus) and Flucelvax (surface antigen, inactivated, prepared in cell cultures, CSL Seqirus) received positive opinions as flu vaccines for patients aged 50 and older, and for adults and children aged 2 and older, respectively.
- Korjuny (catumaxomab, Lindis Biotech) received a positive opinion from the CHMP for the intraperitoneal treatment of malignant ascites.
- Wainzua (eplontersen, AstraZeneca) was recommended for the treatment of adults with transthyretin-mediated amyloidosis, and stage 1 or 2 polyneuropathy.
- Buprenorphine Neuraxpharm (buprenorphine, Neuraxpharm Pharmaceuticals) received a positive opinion for the treatment of opioid dependence.
- Absimky (ustekinumab, Accord Healthcare) and Imuldosa (ustekinumab, Accord Healthcare) received positive opinions as biosimilars to Stelara (J&J), for treating paediatric plaque psoriasis, as well as adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease, or ulcerative colitis.
The following two compounds received negative opinions:
- Following the appeal, the CHMP confirmed their negative opinion to the conditional approval for Masitinib (AB Science) for the treatment of amyotrophic lateral sclerosis (ALS).
- Translarna (ataluren, PTC Therapeutics) received a negative opinion for the renewal of its conditional marketing authorisation for the treatment of Duchenne muscular dystrophy, the effectiveness of the product not being confirmed.
US Food and Drug Administration (FDA)
Vyloy (zolbetuximab-clzb, Astellas Pharma) was approved as a first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive. FDA press release.
Vyalev (foscarbidopa/foslevodopa, AbbVie) was approved for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). AbbVie press release.
New data from clinical trials (Phase 2, Phase 3)
Here are the recent updates on Phase 2 and Phase 3 clinical trials with published data between the 14th and 20th of October 2024:
Supernus Pharmaceuticals shared positive data from Phase 2a study of SPN-820 in adults with major depressive disorder. Supernus press release.
Noema Pharma announced that the Phase 2a study of NOE-105 (gemlapodect) in patients with Tourette syndrome (TS) met both its primary and all key secondary endpoints. Noema Pharma press release.
GSK reported positive results from two Phase 3 trials of depemokimab in patients with chronic rhinosinusitis with nasal polyps. GSK press release.
Wave Life Sciences shared positive data from the Phase 1b/2a study of WVE-006 in alpha-1 antitrypsin deficiency (AATD). Wave Life Sciences press release.
Merck reported positive results from the Phase 2b/3 trial of clesrovimab to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. Merck press release.
Roche presented positive data from the Phase 2 study of Evrysdi (risdiplam) in children with SMA who were treated pre-symptomatically as infants before six weeks of age. Roche press release.
Transgene announced that its therapeutic vaccine candidate TG4001 (tipapkinogene sovacivec) in recurrent or metastatic HPV16-positive cervical and anogenital cancers did not meet its primary endpoint in a Phase 2 study. Transgene press release [pdf].
Innovent Biologics reported that its Phase 2 trial of picankibart (IBI112) in Chinese patients with moderately to severely active ulcerative colitis met the primary endpoint. Innovent press release.
Amylyx Pharmaceuticals shared positive results from the Phase 2 trial of AMX0035 in adults with Wolfram syndrome. Amylyx press release.
Cited Articles
Hoeg-Jensen, T., Kruse, T., Brand, C.L. et al. Glucose-sensitive insulin with attenuation of hypoglycaemia. Nature (2024). https://doi.org/10.1038/s41586-024-08042-3
