Synaptogenix, Inc. te anonse jodi a ke li te fini enskri sib li a nan 100 pasyan pou Enstiti Nasyonal Sante ("NIH") kontinyèl li yo patwone Faz 2b esè klinik Bryostatin-1 pou pasyan ki soufri maladi alzayme avanse ak modere grav ("AD". "). Konpayi an espere anonse premye done etid la pandan katriyèm mwatye 2022.

Synaptogenix rapòte tou ke Komisyon Konsèy Siveyans Sekirite Done endepandan ("DSMB") ki sipèvize esè a te konfime absans nenpòt pwoblèm sekirite negatif ki gen rapò ak dwòg.

Bryostatin-1 te lakòz amelyorasyon koyitif trè enpòtan (sòt sikometrik 4.0 SIB pi wo pase liy debaz) pou pasyan yo pre-espesifye ki te resevwa Bryostatin-1 nan absans Namenda nan de anvan, konsolide 3-mwa esè pilòt nou yo, ki te pibliye dènyèman nan yon kamarad-. revize atik (JAD, 2022) - pandan ke pasyan yo trete plasebo pa montre okenn benefis enpòtan. Tretman Bryostatin-1 kounye a te pwolonje pou genyen ladan yo doub kantite dòz (N = 14) nan 6 mwa aktyèl, jijman plasebo-kontwole, nan ki enskripsyon owaza yo te ak anpil atansyon kontwole pou ekilibre debaz nan tretman an ak kowòt plasebo. Pasyan yo pral obsève pandan twa mwa apre tout sispansyon dòz la, yo bay pèsistans benefis nan pou omwen 30 jou apre dòz ki te deja obsève.

“Nou ankouraje nou ke done pi gwo yo dwe nan 4yèm trimès la, 2022, pral reflete menm benefis oswa pi gwo deja obsève pou pasyan ki nan kowòt ki idantik, ki te deja trete pre-espesifye nan esè pilòt Faz 2a anvan nou yo. Absans nenpòt evènman negatif ki gen rapò ak dwòg, jan yo te obsève ak kèk lòt estrateji terapetik ki rive jwenn apwobasyon limite Food and Drug Administration ("FDA") pou AD, ta dwe fasilite etap ki vin apre nou yo nan direksyon sèvis piblik nan klinik. Benefis ki genyen nan omwen 4.0 nòt SIB, pi wo pase nivo debaz, gen anpil chans pou yo klinikman sans, epi kidonk gen potansyèl pou trete maladi ki kache a epi pou bay soulajman sentòm yo,” te deklare Daniel Alkon, MD, Prezidan ak Ofisye Syantifik anchèf konpayi an. .

Alan Tuchman MD, Direktè Egzekitif Konpayi an, te deklare, “Prèv yo ap grandi e yo kontinye sipòte Bryostatin-1 kòm yon tretman potansyèl pou maladi alzayme a. Nou kontan jodi a pou nou anonse fini enskripsyon Faz 2b nou an epi n ap tann li nan pi gwo done nou yo nan fen ane sa a avèk enpasyans.”

KISA POU RETIRE NAN ATIK SA A:

“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.