Enanta Pharmaceuticals

Robust Pipeline of 55+ Therapies Advancing Toward Potential Functional Cure for Chronic Hepatitis B

a month ago

• Over 50 pharmaceutical companies are actively developing 55+ pipeline therapies for chronic hepatitis B virus (HBV) infection, signaling a robust research landscape aimed at achieving functional cures beyond current suppressive treatments. • Promising candidates include Pradefovir (Ligand Pharmaceuticals) in Phase III and RG6346 (Dicerna/Roche) in Phase II, with the latter demonstrating over 99.9% reduction in circulating HBsAg in preclinical models. • GlaxoSmithKline and Vir Biotechnology are pioneering combination approaches, with GSK evaluating sequential therapy of ASO compound (GSK3228836) and CHB-TI (GSK3528869A) to potentially enhance efficacy over monotherapy in chronic HBV patients.

RSV Treatment Landscape Expands with New Vaccines and Clinical Trials in 2024-2025

3 months ago

• Moderna's mRESVIA vaccine received MHRA approval in February 2025 for adults aged 60 and older, joining GSK's Arexvy and Pfizer's Abrysvo in the expanding RSV vaccine market. • The FDA has mandated new safety warnings for RSV vaccines regarding Guillain-Barré Syndrome risk, highlighting ongoing safety monitoring efforts in early 2025. • Multiple pharmaceutical companies including Sanofi, GSK, and Pfizer are conducting advanced clinical trials in 2024, focusing on various patient populations and novel therapeutic approaches.

Shionogi's Oral Antiviral S-337395 Shows Promise in Phase 2 RSV Human Challenge Trial

4 months ago

• Shionogi's investigational oral antiviral S-337395 significantly reduced viral load in a Phase 2 human challenge trial for Respiratory Syncytial Virus (RSV). • The highest dose group of S-337395 demonstrated an 88.94% reduction in viral load compared to the placebo group (P<0.0001), along with improved clinical symptom scores. • S-337395 was generally safe and well-tolerated, with no serious adverse events reported during the randomized, double-blind, placebo-controlled study. • The drug, which has received FDA Fast Track designation, inhibits the RSV L protein, essential for viral replication, offering a potential new treatment approach.

Enanta Pharmaceuticals' Zelicapavir Shows Promise in Pediatric RSV Trial

5 months ago

• Enanta Pharmaceuticals' zelicapavir achieved a significant 0.7 log reduction in peak viral load on Day 9 in a Phase 2 trial for pediatric RSV patients. • The RSVPEDs study included both hospitalized and non-hospitalized children aged 28 days to 36 months, with consistent results across age groups. • H.C. Wainwright revised its model for Enanta, reducing the price target to $18.00 while maintaining a Buy rating based on the RSVPEDs study data. • Enanta is appealing a court decision that ruled against them in a patent infringement lawsuit with Pfizer over Paxlovid, impacting the company's financial outlook.

Blue Lake Biotech's Intranasal RSV Vaccine Shows Promise in Pediatric Trial

5 months ago

• Blue Lake Biotechnology's BLB201, an intranasal RSV vaccine, demonstrated an 80% reduction in symptomatic RSV infections in infants and young children compared to placebo. • The Phase 1/2a trial (NCT05655182) reported no vaccine-related medically-attended adverse events or serious adverse events, highlighting the vaccine's safety profile. • BLB201 elicits mucosal and cellular immune responses, suggesting a distinct mechanism of protection compared to traditional injectable RSV vaccines. • The ongoing study is set to enroll up to 137 participants, with continued monitoring for safety, tolerability, immunogenicity, and symptomatic RSV infection rates.

Enanta's Zelicapavir Shows Promise in Phase 2 Pediatric RSV Trial

6 months ago

• Enanta Pharmaceuticals reported positive topline results from its Phase 2 trial of zelicapavir for respiratory syncytial virus (RSV) in pediatric patients. • The study, named RSVPEDs, enrolled both hospitalized and non-hospitalized children aged 28 days to 36 months. • Zelicapavir demonstrated a rapid antiviral response, with a 1.2 log decline in viral load in a subset of patients treated early. • The drug was well-tolerated, exhibiting a favorable safety profile compared to placebo in the study population.

Urticaria Clinical Trial Pipeline Heats Up with Novel Therapies in Development

7 months ago

• The urticaria treatment landscape is evolving, with over 20 companies developing more than 25 novel therapies to address unmet patient needs. • Regeneron and Sanofi's Dupixent demonstrated positive Phase III results for chronic spontaneous urticaria, showing promise for biologic-naive patients. • Evommune initiated a Phase II trial of EVO756 for chronic inducible urticaria, while Celldex Therapeutics reported positive Phase II data for barzolvolimab in chronic spontaneous urticaria. • Emerging therapies target various mechanisms, including IgE, mast cells, and kinases, offering diverse approaches to urticaria management.

RSV Therapeutic Pipeline Shows Promise with Novel Therapies and Clinical Advancements

7 months ago

• Over 50 companies are actively developing more than 50 therapeutic options for Respiratory Syncytial Virus (RSV) treatment, indicating a robust pipeline. • GSK's Arexvy vaccine demonstrated encouraging Phase III results, preventing lower respiratory tract disease (LRTD) in older adults across three RSV seasons. • Merck's clesrovimab showed positive topline results in a Phase IIb/III trial as a preventive treatment for RSV in infants, highlighting potential for vulnerable populations.

Enanta Pharmaceuticals' EDP-323 Shows Promise as First Antiviral Treatment for RSV

7 months ago

• Enanta Pharmaceuticals' EDP-323, an investigational RSV inhibitor, demonstrates promising Phase 2a trial results, potentially becoming the first antiviral treatment for RSV infections. • In a human challenge study, EDP-323 significantly reduced viral load (85-87%) and infectious viral load (97-98%) in healthy adults, along with a 66-78% reduction in symptoms compared to placebo. • The oral, once-daily dosing of EDP-323 achieved blood levels significantly exceeding the EC90, indicating potent viral inhibition, and the drug was well-tolerated with no serious adverse events. • With a high unmet need for RSV treatments, especially in vulnerable populations, EDP-323 represents a crucial advancement, complementing existing preventative measures like vaccines.

Enanta Pharmaceuticals Gains Buy Ratings Amid RSV Drug Development Progress

7 months ago

• Enanta Pharmaceuticals receives reiterated Buy ratings from JMP Securities and Robert W. Baird, citing promising RSV drug trial results and reduced competition. • Pfizer's discontinuation of sisunatovir reduces competition for Enanta's RSV therapeutics, potentially benefiting their market position. • Positive results from the pediatric trial of zelicapavir and EDP-323, an oral small-molecule RSV-polymerase inhibitor, drive optimism for Enanta's pipeline. • Enanta's EDP-323 demonstrated a robust impact on viral loads and symptoms in a recent challenge trial, reinforcing confidence in its potential.

Enanta Pharmaceuticals Awaits Phase II Zelicapavir Data for RSV

8 months ago

• Enanta Pharmaceuticals' Zelicapavir (EDP 938) is in Phase II trials (RSVPEDs and RSVHR) targeting RSV in pediatric and high-risk adult populations. • RSVPEDs, a Phase II trial in RSV-infected children aged 28 days to 3 years, has completed enrollment, with topline data expected in Q4 2024. • EDP-323, another RSV drug candidate from Enanta, showed statistically significant reductions in viral load and clinical symptoms in a Phase IIa human challenge study. • Enanta's financial stability is supported by $272.6 million in cash, cash equivalents, and marketable securities as of June 30, 2024, along with royalties from AbbVie's MAVYRET/MAVIRET.

Talvey Shows Promise in Myeloma; FDA Panel Questions PD-1 Use in Gastric Cancers

8 months ago

• Johnson & Johnson's Talvey, combined with Darzalex, demonstrated an 82% response rate in relapsed or refractory multiple myeloma patients, showcasing potential in treating the disease. • An FDA advisory committee raised concerns about the use of PD-1 inhibitors like Keytruda and Opdivo in gastric and esophageal cancers with low PD-L1 levels. • AbbVie's tavapadon, acquired through Cerevel Therapeutics, showed positive Phase 3 results for Parkinson's disease, strengthening its potential as a monotherapy. • Roche's Gazyva met the primary endpoint in a Phase 3 trial for lupus nephritis, demonstrating a higher rate of complete renal response compared to standard therapy alone.

Enanta's EDP-323 Shows Strong Efficacy in RSV Human Challenge Trial

8 months ago

• Enanta Pharmaceuticals' EDP-323 demonstrated significant viral load reduction in a Phase 2a human challenge trial for Respiratory Syncytial Virus (RSV). • The study showed an 85-87% reduction in viral load and a 97-98% reduction in infectious viral load compared to placebo. • EDP-323 also significantly reduced total clinical symptoms by 66-78% and was generally safe and well-tolerated in healthy adults. • These results support EDP-323's potential as a once-daily oral treatment for RSV, with further data to be presented at a future conference.