Synaptogenix, Inc. lero yalengeza kuti yatsiriza kulembetsa cholinga chake cha odwala 100 chifukwa cha kuyesa kwachipatala kwa Phase 2b kwa Bryostatin-1 kwa odwala omwe akudwala Alzheimer's ("AD"). ”). Kampani ikuyembekeza kulengeza zam'tsogolo za kafukufukuyu mchaka chachinayi cha 2022.
Synaptogenix inanenanso kuti bungwe lodziimira pawokha la Data Safety Monitoring Board ("DSMB") lomwe likuyang'anira kuyesako latsimikizira kusakhalapo kwa zovuta zilizonse zokhudzana ndi chitetezo chamankhwala.
Bryostatin-1 idapangitsa kupititsa patsogolo chidziwitso (4.0 SIB psychometric score pamwambapa) kwa odwala omwe adanenedwa kale omwe adalandira Bryostatin-1 kulibe Namenda m'mayesero athu awiri am'mbuyomu, ophatikizidwa amiyezi 3, omwe adasindikizidwa posachedwa ndi anzawo. nkhani yowunikiridwa (JAD, 2022) - pomwe odwala omwe adalandira chithandizo cha Placebo sanawonetse phindu lililonse. Chithandizo cha Bryostatin-1 tsopano chakulitsidwa kuti chiphatikizepo kuwirikiza kawiri kuchuluka kwa Mlingo (N = 14) m'miyezi 6 yamakono, kuyesa koyendetsedwa ndi placebo, komwe kulembetsa mwachisawawa kumayendetsedwa mosamalitsa pazoyambira zokhazikika pazamankhwala ndi magulu a placebo. Odwala akhala akuwonedwa kwa miyezi itatu mutatha kumwa mankhwalawa, chifukwa cha kulimbikira kwa phindu kwa masiku osachepera 30 mutatha kumwa mankhwalawa.
"Ndife olimbikitsidwa kuti zomwe zidapezeka mu kota ya 4, 2022, ziwonetsa phindu lomwelo kapena lalikulu lomwe lawonedwa kale kwa odwala omwe ali m'magulu omwe adanenedwa kale m'mayesero athu am'mbuyomu a Phase 2a. Kusapezeka kwa zovuta zilizonse zokhudzana ndi mankhwala, monga tawonera ndi njira zina zochiritsira zomwe zidafikira kuvomerezedwa ndi Food and Drug Administration ("FDA") ku AD, kuyenera kutithandizira zomwe titha kuchita pazachipatala. Phindu la osachepera 4.0 SIB scores, pamwamba pa zoyambira, atha kukhala atanthauzo, motero ali ndi kuthekera kochiza matenda omwe ayambitsa matendawa komanso kupereka mpumulo wazizindikiro," adatero Daniel Alkon, MD, Purezidenti wa Company ndi Chief Scientific Officer. .
Alan Tuchman MD, Chief Executive Officer wa Kampani, adati, "Umboni ukukula ndipo ukupitilizabe kuthandizira Bryostatin-1 ngati chithandizo chotheka ku matenda a Alzheimer's. Ndife okondwa lero kulengeza kumalizidwa kwa olembetsa athu a Phase 2b ndipo tikuyembekezera mwachidwi kuti ziwerengero zathu zapamwamba kumapeto kwa chaka chino. ”
ZOMWE MUNGACHITE PA NKHANIYI:
- “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.
