I-Synaptogenix, Inc. namhlanje ibhengeze ukuba igqibile ukubhalisa i-target yayo yezigulane ze-100 kwi-National Institutes of Health eqhubekayo ("NIH") exhaswayo kwiSigaba se-2b solingo lwezonyango lwe-Bryostatin-1 kwizigulane ezinesifo se-Alzheimer esiphakamileyo kunye nesimo esibi kakhulu ("AD ”). Inkampani ilindele ukubhengeza idatha ephezulu evela kuphononongo ngekota yesine ka-2022.
I-Synaptogenix iphinda ibike ukuba iBhodi yoKhuseleko lweDatha ezimeleyo ("i-DSMB") ejongene nolingo iqinisekisile ukungabikho kwayo nayiphi na imiba yokhuseleko olubi olunxulumene neziyobisi.
I-Bryostatin-1 ibangele uphuculo olubaluleke kakhulu lwengqondo (i-4.0 SIB inqaku le-psychometric ngasentla kwesiseko) kwizigulana ezichazwe kwangaphambili ezifumene i-Bryostatin-1 ngokungabikho kwe-Namenda kulingo lwethu lwangaphambili, oludityanisiweyo lweenyanga ezi-3, olupapashwe kutshanje kwintanga- inqaku elihlaziyiweyo (i-JAD, i-2022) - ngelixa izigulane eziphathwe nge-Placebo zibonise ukuba akukho nzuzo ebalulekileyo. Unyango lwe-Bryostatin-1 ngoku luye lwandiswa ukuba lubandakanye kabini inani leedosi (N = 14) kwinyanga yangoku ye-6, isilingo esilawulwa yi-placebo, apho ukubhaliswa okungahleliwe kuye kwalawulwa ngokucophelela kwiziseko ezilinganayo kunyango kunye neqela le-placebo. Izigulana ziya kube ziqwalaselwe ixesha elide kangangeenyanga ezintathu emva kokuyekwa kwayo yonke idosi, kunikwe ukuzingisa kwenzuzo ubuncinci beentsuku ezingama-30 emva kokudosa obekubonwe ngaphambili.
“Siyakhuthazwa ukuba eyona datha iphezulu efunekayo kwikota yesi-4, ka-2022, izakubonisa inzuzo efanayo okanye enkulu esele ibonwe kwizigulana ezikumaqela afanayo, asele enyangwe ngaphambili kulingo lwethu lwangaphambili lweSigaba sesi-2a. Ukungabikho kwazo naziphi na iziganeko ezibi ezinxulumene nechiza, njengoko kuye kwaphawulwa kunye nezinye iindlela ezimbalwa zonyango ezifikelela kwimvume yoLawulo lokuTya kunye neDrugs (“FDA”) ye-AD, kufuneka iququzelele amanyathelo ethu alandelayo ngokubhekiselele kuncedo lwezonyango. Izibonelelo zobuncinci ze-4.0 SIB amanqaku, ngaphezulu kwesiseko, anokuba nentsingiselo ekliniki, kwaye ke ngoko abenakho ukunyanga isifo esisisiseko kunye nokubonelela ngesiqabu seempawu, utshilo uDaniel Alkon, MD, uMongameli weNkampani kunye neGosa eliyiNtloko lezeNzululwazi. .
U-Alan Tuchman MD, uMphathi oyiNtloko weNkampani, wathi, "Ubungqina bukhula kwaye buyaqhubeka nokuxhasa i-Bryostatin-1 njengonyango olunokubakho kwi-Alzheimer's disease. Sinochulumanco namhlanje ukubhengeza ukugqitywa kobhaliso lwethu lweSigaba 2b kwaye silindele ngolangazelelo ukufundwa kwedatha yethu ephezulu ekupheleni kwalo nyaka. "
INTO ONOKUYITHATHA KWELI NQAKU:
- “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.
