Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MHAA4549A · 2 trials · 2 indications
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.
The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.
| Arm | Type | Description |
|---|---|---|
| MHAA4549A 3600 milligrams (mg) | EXPERIMENTAL | Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration. |
| MHAA4549A 8400 mg | EXPERIMENTAL | Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive single-dose placebo by IV administration. |
| A: MHAA4549A 3600 mg + Oseltamivir | EXPERIMENTAL | Participants will receive a single low IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days. |
| B: MHAA4549A 8400 mg + Oseltamivir | EXPERIMENTAL | Participants will receive a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days. |
| C: Placebo + Oseltamivir | PLACEBO_COMPARATOR | Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy (75 or 150 mg BID) for minimum of 5 days. |
| Name | Type | Description |
|---|---|---|
| MHAA4549A | DRUG | MHAA4549A will be administered as a single dose by IV administration. |
| Placebo | DRUG | Placebo will be administered as a single dose by IV administration. |
| Oseltamivir | DRUG | Participants will receive oseltamivir capsule either 75 mg or 150 mg BID orally for minimum of 5 days. Dosage and administration should follow local prescribing information for oseltamivir. |
Inclusion Criteria: * Otherwise healthy participants * Positive test for influenza A infection * No more than 72 hours elapsed between onset of influenza-like illness and start of study drug * Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chill...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
MHAA4549A is an investigational therapy being studied for the treatment of influenza, including influenza A. It has been evaluated in clinical trials for acute uncomplicated seasonal influenza A in otherwise healthy adults and for severe influenza A infection in combination with oseltamivir. It is not approved for any indication.
MHAA4549A is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the clinical trials evaluating the drug in influenza A.
MHAA4549A is in Phase 2 clinical development. It has completed two Phase 2 trials, one as monotherapy for acute uncomplicated seasonal influenza A and one in combination with oseltamivir for severe influenza A infection. It is not FDA approved.
MHAA4549A has been studied in two completed Phase 2 trials: NCT02623322, which evaluated it as monotherapy for acute uncomplicated seasonal influenza A in otherwise healthy adults, and NCT02293863, which tested it in combination with oseltamivir versus oseltamivir alone in participants with severe influenza A infection.
No, MHAA4549A is not FDA approved. It remains an investigational drug that has completed Phase 2 clinical development for influenza A. No regulatory approval has been granted for any indication.