Codagenix pursues RSV vaccine development amid unexpected challenges
30 Aug 2023
VaccinePhase 1Fast TrackDrug ApprovalPhase 2
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Source: Pharmaceutical Technology
Akosua Mireku
@AkosuaMireku1
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Source: Pharmaceutical Technology
The reason for the trial delay was related to an issue with finding seropositive older toddlers due to the isolation of this age group during the pandemic. Credit: graphixchon via Getty Images.
Free Buyers GuideCodagenix pursues RSV vaccine development amid unexpected challengesThe document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision.
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Source: Pharmaceutical Technology
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In an interview with Pharmaceutical Technology, chief business officer Jeffrey Fu said the New York-headquartered company has faced unexpected challenges in a Phase I study of the vaccine causing a one-year alteration in its clinical development timeline.
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The Phase I study (NCT04919109) began dosing in the US in May 2023, but Fu says that as the RSV season approaches in the US the study will shift to sites in South Africa.
He said: “We want to work in a time when there’s less likelihood of natural RSV circulating in the environment because that will confound the study.”
In the US, RSV season typically starts during autumn and peaks in winter.
Fu says that the trial is progressing at a slower pace than was initially expected with new estimates for the release of topline data landing in the second half of 2024. These results will comprise safety and immunogenicity data for the vaccine.
The reason for the trial delay was related to an issue with finding seropositive older toddlers due to the isolation of this age group during the Covid-19 pandemic. In the Phase I trial, the company is first dosing seropositive children who have been previously infected by RSV before moving on to the seronegative population.
This has been an eventful time for RSV vaccines after years of inactivity. In May 2023, the US Food and Drug Administration (FDA) approved GSK’s Arexvy as the first RSV vaccine available in the US. The vaccine was developed for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Following this, Pfizer secured the first FDA approval for an RSV vaccine for pregnant individuals, with its Abrysvo vaccine.
The Phase I results would inform planning for a Phase II trial dose escalation study. Fu predicts that this trial will begin in 2025. Codagenix is using financing from its $25m Series B funding extension to push the development of its RSV clinical programme.
Codagenix is also developing the vaccine for an adult patient population. In November 2022, the FDA granted the company fast track designation to expedite the development and review of the vaccine.
Free Buyers GuideTop Guide for Clinical Trials and Development ServicesThe document includes detailed information on the manufacturers and suppliers and their products, along with contact details, to inform your purchasing decision.
Thank you.Your download email will arrive shortly.While you wait why not take a look at other free recommend buyer’s guides
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Algeria (+213)
Andorra (+376)
Angola (+244)
Anguilla (+1264)
Antigua & Barbuda (+1268)
Argentina (+54)
Armenia (+374)
Aruba (+297)
Australia (+61)
Austria (+43)
Azerbaijan (+994)
Bahamas (+1242)
Bahrain (+973)
Bangladesh (+880)
Barbados (+1246)
Belarus (+375)
Belgium (+32)
Belize (+501)
Benin (+229)
Bermuda (+1441)
Bhutan (+975)
Bolivia (+591)
Bosnia Herzegovina (+387)
Botswana (+267)
Brazil (+55)
Brunei (+673)
Bulgaria (+359)
Burkina Faso (+226)
Burundi (+257)
Cambodia (+855)
Cameroon (+237)
Canada (+1)
Cape Verde Islands (+238)
Cayman Islands (+1345)
Central African Republic (+236)
Chile (+56)
China (+86)
Colombia (+57)
Comoros (+269)
Congo (+242)
Cook Islands (+682)
Costa Rica (+506)
Croatia (+385)
Cuba (+53)
Cyprus North (+90392)
Cyprus South (+357)
Czech Republic (+42)
Denmark (+45)
Djibouti (+253)
Dominica (+1809)
Dominican Republic (+1809)
Ecuador (+593)
Egypt (+20)
El Salvador (+503)
Equatorial Guinea (+240)
Eritrea (+291)
Estonia (+372)
Ethiopia (+251)
Falkland Islands (+500)
Faroe Islands (+298)
Fiji (+679)
Finland (+358)
France (+33)
French Guiana (+594)
French Polynesia (+689)
Gabon (+241)
Gambia (+220)
Georgia (+7880)
Germany (+49)
Ghana (+233)
Gibraltar (+350)
Greece (+30)
Greenland (+299)
Grenada (+1473)
Guadeloupe (+590)
Guam (+671)
Guatemala (+502)
Guinea (+224)
Guinea - Bissau (+245)
Guyana (+592)
Haiti (+509)
Honduras (+504)
Hong Kong (+852)
Hungary (+36)
Iceland (+354)
India (+91)
Indonesia (+62)
Iran (+98)
Iraq (+964)
Ireland (+353)
Israel (+972)
Italy (+39)
Jamaica (+1876)
Japan (+81)
Jordan (+962)
Kazakhstan (+7)
Kenya (+254)
Kiribati (+686)
Korea North (+850)
Korea South (+82)
Kuwait (+965)
Kyrgyzstan (+996)
Laos (+856)
Latvia (+371)
Lebanon (+961)
Lesotho (+266)
Liberia (+231)
Libya (+218)
Liechtenstein (+417)
Lithuania (+370)
Luxembourg (+352)
Macao (+853)
Macedonia (+389)
Madagascar (+261)
Malawi (+265)
Malaysia (+60)
Maldives (+960)
Mali (+223)
Malta (+356)
Marshall Islands (+692)
Martinique (+596)
Mauritania (+222)
Mayotte (+269)
Mexico (+52)
Micronesia (+691)
Moldova (+373)
Monaco (+377)
Mongolia (+976)
Montserrat (+1664)
Morocco (+212)
Mozambique (+258)
Myanmar (+95)
Namibia (+264)
Nauru (+674)
Nepal (+977)
Netherlands (+31)
New Caledonia (+687)
New Zealand (+64)
Nicaragua (+505)
Niger (+227)
Nigeria (+234)
Niue (+683)
Norfolk Islands (+672)
Northern Marianas (+670)
Norway (+47)
Oman (+968)
Palau (+680)
Panama (+507)
Papua New Guinea (+675)
Paraguay (+595)
Peru (+51)
Philippines (+63)
Poland (+48)
Portugal (+351)
Puerto Rico (+1787)
Qatar (+974)
Reunion (+262)
Romania (+40)
Russia (+7)
Rwanda (+250)
San Marino (+378)
Sao Tome & Principe (+239)
Saudi Arabia (+966)
Senegal (+221)
Serbia (+381)
Seychelles (+248)
Sierra Leone (+232)
Singapore (+65)
Slovak Republic (+421)
Slovenia (+386)
Solomon Islands (+677)
Somalia (+252)
South Africa (+27)
Spain (+34)
Sri Lanka (+94)
St. Helena (+290)
St. Kitts (+1869)
St. Lucia (+1758)
Sudan (+249)
Suriname (+597)
Swaziland (+268)
Sweden (+46)
Switzerland (+41)
Syria (+963)
Taiwan (+886)
Tajikstan (+7)
Thailand (+66)
Togo (+228)
Tonga (+676)
Trinidad & Tobago (+1868)
Tunisia (+216)
Turkey (+90)
Turkmenistan (+7)
Turkmenistan (+993)
Turks & Caicos Islands (+1649)
Tuvalu (+688)
Uganda (+256)
UK (+44) -->
Ukraine (+380)
United Arab Emirates (+971)
Uruguay (+598)
USA (+1) -->
Uzbekistan (+7)
Vanuatu (+678)
Vatican City (+379)
Venezuela (+58)
Vietnam (+84)
Virgin Islands - British (+1284)
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Wallis & Futuna (+681)
Yemen (North)(+969)
Yemen (South)(+967)
Zambia (+260)
Zimbabwe (+263)
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Cambodia
Cameroon
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Cape Verde
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Central African Republic
Chad
Chile
China
Christmas Island
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Congo
Democratic Republic of
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Cook Islands
Costa Rica
Côte d"Ivoire
Croatia
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Iraq
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Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kuwait
Kyrgyzstan
Lao
Latvia
Lebanon
Lesotho
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Libyan Arab Jamahiriya
Liechtenstein
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Macedonia, The Former
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New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
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Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and The South
Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
British Virgin Islands
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Kosovo
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