Synaptogenix, Inc. nhasi yakazivisa kuti yapedza kunyoresa chinangwa chayo chevarwere ve100 nekuda kwekuenderera kwayo National Institutes of Health ("NIH") yakatsigira Phase 2b yekiriniki yekuedza yeBryostatin-1 kune varwere vane chirwere cheAlzheimer's chepamusoro uye chine mwero ("AD). ”). Kambani inotarisira kuzivisa data repamusoro kubva muchidzidzo mukati mechikamu chechina cha2022.
Synaptogenix inoshumawo kuti yakazvimirira Data Safety Monitoring Board (“DSMB”) inotarisira kutongwa yakasimbisa kusavapo kwechero nyaya dzine chekuita nezvinodhaka.
Bryostatin-1 yakakonzera kuwedzeredza kwakakosha kwekuziva (4.0 SIB psychometric mamakisi pamusoro pekutanga) kune varwere vakambotaurwa vakagamuchira Bryostatin-1 mukushayikwa kwaNamenda mune yedu miviri yapfuura, yakabatanidza 3-mwedzi miyedzo yekutyaira, ichangobva kuburitswa mune vezera- yakaongororwa chinyorwa (JAD, 2022) - nepo varwere vakarapwa nePlacebo vakaratidza kusakosha kwakakosha. Bryostatin-1 kurapwa ikozvino yakawedzerwa kuti ibatanidze kaviri nhamba yedosi (N = 14) mumwedzi we6 ikozvino, muedzo unodzorwa ne placebo, umo kunyoreswa kwakasarudzika kwakanyatso kudzorwa kune yakaenzana yekutanga mukurapa uye placebo cohorts. Varwere vachange vachicherechedzwa kwenguva yakareba semwedzi mitatu mushure mekumira kwese dosing, vachipihwa kushingirira kwekubatsira kwemazuva makumi matatu mushure mekutora kwaimboonekwa.
"Tinokurudzirwa kuti data repamusoro rakafanirwa muchikamu chechina, 4, richaratidza rubatsiro rwakafanana kana rwakakura rwakatoonekwa kune varwere vakafanana, vakamborapwa macohorts ekare muyedzo yedu yapfuura Phase 2022a. Kusavapo kwechero zviitiko zvine chekuita nezvinodhaka, sezvakacherechedzwa nedzimwe nzira shoma dzekurapa dzinosvika kubvumidzwa kweChikafu neDrug Administration ("FDA") yeAD, kunofanirwa kufambisa nhanho dzedu dzinotevera dzekushandisa kukiriniki. Mabhenefiti angangoita 2 SIB zvibodzwa, pamusoro pekutanga, anogona kunge ane zvazvinoreva muchipatara, uye nekudaro ane mukana wekurapa chirwere chiri pasi uye nekupa zororo rezviratidzo, "akadaro Daniel Alkon, MD, Mutungamiriri weKambani uye Chief Sainzi Officer. .
Alan Tuchman MD, Chief Executive Officer weKambani, akati, "Uchapupu huri kukura uye huri kuramba huchitsigira Bryostatin-1 semushonga unogona kurapa chirwere cheAlzheimer. Tinofara nhasi kuzivisa kupera kwekunyoresa kwedu Phase 2b uye takamirira nechido kuverengwa kwedata redu repamusoro gare gare gore rino. "
ZVOKUBVA MUNYAYA INO:
- “We are encouraged that the top line data due in the 4th quarter, 2022, will reflect the same or greater benefit already observed for patients in identical, previously treated pre-specified cohorts in our previous Phase 2a pilot trials.
- Bryostatin-1 treatment has now been extended to include double the number of doses (N = 14) in the current 6-month, placebo-controlled trial, in which randomized enrollment has been carefully controlled for balanced baselines in the treatment and placebo cohorts.
- 0 SIB psychometric score above baseline) for the pre-specified patients who received Bryostatin-1 in the absence of Namenda in our two previous, consolidated 3-month pilot trials, recently published in a peer-reviewed article (JAD, 2022) – while the Placebo-treated patients showed no significant benefit.
