Anavex Life Sciences said the FDA has cleared its investigational new drug application for blarcamesine in Fragile X syndrome, allowing a planned Phase 2a study to proceed in the United States. The randomised, double blind, placebo controlled, dose ranging study will enrol approximately 60 adult males and focus on safety, tolerability and pharmacokinetics, with behaviour and cognition measures as secondary endpoints. Fragile X is the most common inherited cause of intellectual disability and has no FDA approved treatment; blarcamesine already held orphan drug designation for the condition, and Anavex now has open INDs across its three core indications of Alzheimer’s disease, Rett syndrome and Fragile X. An IND clearance is permission to test, not evidence the drug works.
The Africa Centres for Disease Control and Prevention has reaffirmed its support for Kenya’s Ebola response, in a statement issued October 17, and called for stronger cross border surveillance across the region. Kenya’s confirmed Bundibugyo cases stand at seven, including one death, with the four newest cases all detected among people already in quarantine: 128 of 130 identified contacts have been traced, and the health ministry reports no evidence of community transmission. The case count itself was published in this site’s October 17 story, which has been updated with the Africa CDC statement; the new element is the continental agency’s formal backing and its push for regional information sharing while the Congo outbreak, the source of Kenya’s imported case, continues.
Referenced, not repeated: the Suffolk County jury verdict awarding David Sabatini 6 million dollars, the single_source flag in this run’s gap check, was published in full on October 17 as its own story and has not materially changed since. Also ahead this week, City Therapeutics’ upsized IPO is expected to close on Monday, October 19, completing the offering corrected in Saturday’s edition.