Glenmark Pharmaceuticals Limited (Glenmark) - k'hamphani ea lefats'e ea meriana - le k'hamphani ea meriana ea Canada SaNOtize Research & Development Corp., kajeno e phatlalalitse phatlalatso ea eona ea Nitric Oxide Nasal Spray tlasa lebitso la lebitso la FabiSpray® India bakeng sa kalafo ea bakuli ba baholo ba nang le COVID-19. ba nang le kotsi e kgolo ya ho tswela pele hoa lefu lena. Glenmark pejana e amohetse tumello ea ho etsa le ho bapatsa ho tsoa ho Molaoli Kakaretso oa Lithethefatsi oa India (DCGI) bakeng sa NONS e le karolo ea ts'ebetso e potlakileng ea tumello.
FabiSpray®, Nitric Oxide Nasal Spray, e etselitsoe ho bolaea kokoana-hloko ea COVID-19 litseleng tse ka holimo tsa moea. E na le thepa ea anti-microbial e netefalitsoeng e nang le phello e tobileng ea virucidal ho SARS-CoV-2. NONS ha e fafatsoa holim'a mucosa ea nko e sebetsa e le thibelo ea 'mele le ea lik'hemik'hale khahlanong le kokoana-hloko, e e thibelang ho mela le ho namela matšoafong.
Ha a bua ka bohlokoa ba nts'etsopele ena, Robert Crockart, Ofisiri e ka Sehloohong ea Khoebo, Glenmark Pharmaceuticals Ltd. o itse, "Joaloka sebapali se etelletseng pele sa meriana, ho bohlokoa hore re be karolo ea bohlokoa ea ntoa ea India khahlanong le seoa sa COVID-19. Re thabetse ho fumana tumello ea taolo ea Nitric Oxide Nasal Spray (FabiSpray®) le ho e qala ka kopanelo le SaNOtize. Sena se tiisa boitlamo ba rona ba ho fana ka kalafo e 'ngoe hape e bolokehileng le e sebetsang ea antiviral bakeng sa COVID-19, 'me re ts'epa hore e tla fa bakuli khetho ea kalafo e hlokahalang haholo le e nakong. ”
Liphello tsa Teko ea Meriana ea Mokhahlelo oa 3 oa India
• Teko ea bongaka ea Mokhahlelo oa 3 e entsoe ho bakuli ba batho ba baholo ba COVID-19 libakeng tse 20 tsa bongaka India. Boithuto bo bongata bo sa boneng, bo nang le letsoho le tšoanang, bo entsoeng ho bakuli ba 306 bo ile ba lekola katleho le polokeho ea Nitric Oxide Nasal Spray khahlano le setlolo se tloaelehileng sa nasal saline ho bakuli ba seng ba kena sepetlele. Bakuli bohle ba fumane tlhokomelo e tloaelehileng ea tšehetso thutong.
• Teko e ile ea hlahloba bakuli ba nang le kotsi ea tsoelo-pele ea lefu - bakuli ba sa entoeng, bakuli ba sehlopha sa batho ba lilemo tse bohareng le ba baholo le bakuli ba nang le mafu a kopanetsoeng.
• Qetello ea mantlha e ile ea fihleloa: Phokotso ea palo ea kokoana-hloko ea log sehlopheng sa NONS e ne e le ea bohlokoa ka lipalo-palo 'me e phahametse sehlopha sa taolo (placebo) (p <0.05).
• Nako e mahareng ea pheko ea kokoana-hloko e ne e le matsatsi a 4 ho sehlopha sa NONS le matsatsi a 8 sehlopheng sa placebo (p <0.05).
• Palo e phahameng haholo ea bakuli e bontšitse ntlafatso ea lintlha tsa 2 ho WHO Progression Scale (e leng sephetho se tiisitsoeng sa kliniki) sehlopheng sa NONS ha se bapisoa le sehlopha sa placebo (p <0.05).
• NONS e ne e bolokehile mme e mamelloa hantle ke bakuli. Ha ho bakuli ba bileng le Liketsahalo tse mpe tse itekanetseng, tse matla, tse tebileng (AE) kapa lefu thutong.
Dr. Monika Tandon, Senior VP & Head - Clinical Development, Glenmark Pharmaceuticals Ltd., o ile a fana ka maikutlo: "Liphetho tsa Mokhahlelo ona oa 3, teko e laoloang ke batho ba sa boneng habeli, ea placebo e ea khothatsa. Pontšo ea phokotso ea bongata ba kokoana-hloko e na le phello e ntle e ntle ho tloha ponong ea mokuli le ea sechaba. Boemong ba hajoale, ka mefuta e mecha e hlahang e bonts'ang phetisetso e phahameng, NONS e fana ka khetho e molemo ntoeng ea India khahlanong le COVID-19. "
Ka Hlakubele 2021, liteko tsa tleliniki tse tsoang ho moqapi oa eona, SaNOtize li bonts'itse NONS e ne e le kalafo e sireletsehileng le e sebetsang ea antiviral ea SARS CoV-2. Lihoreng tse 24 tsa pele, NONS e ile ea fokotsa sekhahla sa bongata ba vaerase ka hoo e ka bang 95%, 'me ea feta 99% nakong ea lihora tse 72. (Tekong ea India Phase 3, phokotso ea bongata ba kokoana-hloko ea 94% ka lihora tse 24 le 99% ka lihora tse 48 e ne e tšoana le phokotso e bonoang tekong ea UK NHS e entsoeng ke SaNOtize). NONS e kile ea lekoa ho baithaopi ba phetseng hantle le bakuli e le karolo ea liteko tsa bongaka tsa Canada le UK. SaNOtize e na le teko e tsoelang pele ea thibelo ea Mokhahlelo oa 3 lefatšeng ka bophara, e tla eketsa katleho ea eona. Joalo ka liphuputso tse entsoeng Univesithing ea Utah State USA, NONS e netefalitsoe hore e bolaea 99.9% ea vaerase ea SARS-Cov-2 ho kenyeletsoa mofuta oa Alpha, Beta, Gamma, Delta, le Epsilon nakong ea metsotso e 2.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- (In the India Phase 3 trial, a reduction of viral load of 94% in 24 hours and 99% in 48 hours was similar to reduction seen in the UK NHS trial conducted by SaNOtize).
- A significantly higher proportion of patients demonstrated a 2-point improvement on the WHO Progression Scale (a validated clinical endpoint) in the NONS group as compared to the placebo group (p <.
- , today announced launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray® in India for the treatment of adult patients with COVID-19 who have a high risk of progression of the disease.
