Interferon beta-1a
- Generic Name
- Interferon beta-1a
- Brand Names
- Avonex, Rebif
- Drug Type
- Biotech
- CAS Number
- 145258-61-3
- Unique Ingredient Identifier
- XRO4566Q4R
- Background
Human interferon beta (166 residues), glycosylated, MW=22.5kD. It is produced by mammalian cells (Chinese Hamster Ovary cells) into which the human interferon beta gene has been introduced. The amino acid sequence is identical to that of natural human interferon beta.
- Indication
For treatment of relapsing/remitting multiple sclerosis, also for condyloma acuminatum
- Associated Conditions
- Relapsing Multiple Sclerosis (RMS)
NLS Pharmaceutics Secures $28 Million in Financing to Advance Merger with Kadimastem and Cell Therapy Pipeline
• NLS Pharmaceutics has closed a $2 million equity financing at a 10% premium to market price, with potential for an additional $1 million, alongside a $25 million committed equity facility to support its planned merger with Kadimastem.
• The funding will enable the merged company to advance Kadimastem's AstroRx® Phase IIa clinical trial for Amyotrophic Lateral Sclerosis (ALS) and IsletRx Phase I trial for type 1 diabetes following the merger completion.
• The strategic merger aims to create a leading regenerative medicine company combining NLS's CNS expertise with Kadimastem's cell therapy platform for neurodegenerative diseases and diabetes.
Merck's Enpatoran Shows Promise for Lupus Rash in Phase 2 Trial Despite Mixed Results
• Merck's oral TLR7/8 inhibitor enpatoran demonstrated clinically meaningful reduction in disease activity for patients with cutaneous lupus erythematosus and systemic lupus erythematosus with active lupus rash in the Phase 2 WILLOW study.
• The drug met its primary endpoint in Cohort A with up to 91.3% of patients achieving CLASI-50 response at Week 24, though it failed to meet the primary endpoint in the systemic lupus erythematosus cohort (Cohort B).
• As a potential first-in-class oral therapy targeting the TLR7/8 pathway, enpatoran could address significant unmet needs for lupus patients, with Merck now in discussions with health authorities regarding a global Phase 3 program.
Faron's Traumakine for ARDS Receives UK's Promising Innovative Medicines Status
• Faron Pharmaceuticals' lead product Traumakine, an intravenous interferon beta treatment for Acute Respiratory Distress Syndrome, has been granted PIM designation by UK authorities.
• The designation follows FDA's encouragement to proceed with filing upon positive Phase 3 results, potentially accelerating market access for the first approved ARDS treatment.
• ARDS, affecting over 300,000 patients annually in Europe and US with a 30-45% mortality rate, currently has no approved pharmaceutical treatments.
Synairgen Advances to Phase 3 Trial of Inhaled COVID-19 Treatment SNG001
Synairgen has initiated a phase 3 trial for SNG001, an inhaled interferon beta-1a treatment for hospitalized COVID-19 patients requiring oxygen. Following promising phase 2 results, the trial aims to enroll 610 patients across 20 countries, with emergency approvals potentially available by autumn. The treatment, already used in injectable form for multiple sclerosis, targets low interferon beta levels in the lungs of severely ill COVID-19 patients.
Synairgen Secures £18 Million to Advance Phase 2 Trial of SNG001 in Mechanically Ventilated Patients
• Synairgen has secured £18 million to fund a Phase 2 trial of SNG001, an inhaled interferon beta treatment, in mechanically ventilated patients with respiratory viral infections.
• The trial aims to evaluate SNG001's ability to reduce mortality rates, which currently range from 25% to 45% in this high-risk patient population.
• TFG Asset Management is providing the funding, which will cover trial costs up to interim analysis, drug manufacturing, and stability testing.
• The Phase 2 trial, expected to commence in early 2025, will enroll 450 patients to assess the efficacy of SNG001 in boosting the lungs' antiviral responses.
Kadimastem and iTolerance Seek FDA Input for Novel Type 1 Diabetes Therapy, iTOL102
• Kadimastem and iTolerance have submitted a request for a Pre-IND meeting with the FDA for iTOL102, a novel treatment for Type 1 Diabetes.
• iTOL102 combines allogeneic stem cell-derived pancreatic islets with an immunomodulator to potentially cure Type 1 Diabetes.
• Preclinical studies of iTOL102 at the Diabetes Research Institute showed functional insulin release and disease reversal in animal models.
• NLS Pharmaceutics anticipates its merger with Kadimastem will enhance its pipeline with valuable assets, pending shareholder approval.
Ocrevus Shows Long-Term Benefits as First-Line Treatment for Early Relapsing MS
• Early use of Ocrevus in relapsing MS significantly delays disease progression compared to starting with less effective treatments and switching later.
• After nine years, nearly half of early MS patients treated with Ocrevus achieved no evidence of disease activity (NEDA-3), almost twice the rate of those initially on Rebif.
• Starting Ocrevus early leads to sustained benefits, including lower relapse rates and reduced brain volume loss, highlighting the importance of early intervention.
• The safety profile of Ocrevus remained consistent over nine years, reinforcing its favorable benefit-risk profile as a first-line therapy for early relapsing MS.
Synairgen's SNG001 Shows Promise in Reducing COVID-19 Severity
• Synairgen's SNG001, an inhaled interferon beta formulation, significantly improved recovery rates in COVID-19 patients compared to placebo, showing a major breakthrough.
• Patients receiving SNG001 were 79% less likely to develop severe COVID-19, highlighting the drug's potential to mitigate disease progression.
• The discovery that individuals with asthma and chronic lung disease lack interferon beta led to SNG001's development, aiming to bolster the body's antiviral defenses.
• Due to the successful trial, production of SNG001 has been scaled up to over a million doses in preparation for potential future waves of the virus.
EMA Recommends Approval for Biogen's Leqembi with Patient Limitations
• The European Medicines Agency (EMA) has reversed its previous decision and now recommends approval for Biogen's Leqembi, an Alzheimer's drug, in Europe.
• The approval is limited to specific patient populations based on genetic markers, potentially impacting around 30% of the drug's global sales.
• Despite the positive EMA decision, Biogen faces challenges including pricing, reimbursement, logistical issues, and the need to expand its product pipeline.
• Leqembi demonstrated significant slowing of cognitive decline in specific patient groups, supporting potential for increased market adoption and revenue generation.
UCB and Biogen's Dapirolizumab Pegol Shows Promise in Phase 3 Lupus Trial
• UCB and Biogen's dapirolizumab pegol met the primary endpoint in a Phase 3 trial for moderate-to-severe systemic lupus erythematosus (SLE).
• The drug demonstrated significant clinical improvement in disease activity compared to placebo when added to standard of care.
• A second Phase 3 trial, PHOENYCS FLY, is planned to further evaluate the efficacy and safety of dapirolizumab pegol in SLE patients.
• Dapirolizumab pegol targets the CD40L pathway, offering a novel approach to reduce B cell activation and autoantibody production in SLE.
Ozanimod Shows Sustained Reduction in Brain Atrophy in Relapsing Multiple Sclerosis
• Long-term data from the DAYBREAK trial shows ozanimod treatment resulted in sustained reductions in brain volume loss (BVL) for up to 5 years in relapsing MS patients.
• Patients on continuous ozanimod demonstrated stable and low rates of whole brain volume loss compared to those who switched from interferon-beta-1a.
• Switching to ozanimod from interferon-beta-1a reduced rates of whole brain volume loss and reversed cortical grey matter volume loss trends.
• After 72 months, ozanimod treatment showed a low adjusted annualized relapse rate, with a majority of patients remaining relapse-free.
Roche's Ocrevus to Match Novartis's Gilenya Pricing in UK MS Market
• Roche announces pricing strategy for Ocrevus in the UK multiple sclerosis market, aligning costs with Novartis's Gilenya at approximately £19,169 per patient annually.
• Ocrevus becomes the first approved treatment for primary progressive MS (PPMS), though NICE approval for this indication may face longer review timelines.
• The drug has demonstrated strong efficacy in relapsing MS with no direct links to PML, positioning it favorably against competitors like Biogen's Tysabri and Tecfidera.
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