Target to $1 from $6
Wednesday, June 8, 2022
Stealth: Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Model
Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today the presentation of new SBT-272 preclinical data demonstrating functional improvement in upper motor neurons with TDP-43 pathology, which plays a significant role in both amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The data were presented at the Keystone Neurodegeneration Symposium in Keystone, CO held June 5-9, 2022. A Phase 1 study to evaluate the safety and tolerability of SBT-272 in healthy volunteers is underway.
SBT-272 significantly improved mitochondrial structural integrity and motility in TDP-43 mutant (A315T)-expressing upper motor neurons. These enhancements in mitochondrial health were associated with improved axon outgrowth, a key indicator of improved neuronal health. The effect of SBT-272 on axon outgrowth was superior to edaravone (approved for the treatment of ALS) and AMX0035 (NDA under FDA review). Chronic in vivo administration of SBT-272 reduced upper motor neuron degeneration and neuroinflammation in the motor cortex of the prp‐hTDP‐43A315T‐UeGFP mouse model of ALS. Together, these data support further investigation of SBT-272 as a potential treatment for ALS with TDP-43 pathology.
https://finance.yahoo.com/news/stealth-biotherapeutics-presents-sbt-272-112000096.html
Lebrikizumab’s convenience edge emerges
It is a truth universally acknowledged that Lilly and Almirall’s IL-13 inhibitor lebrikizumab, if approved, will have a hard time going up against Sanofi and Regeneron’s Dupixent in atopic dermatitis. But at least the newcomers have a new weapon in their armoury: convenience. Data from the one-year maintenance periods of the pivotal Advocate-1 and 2 trials, toplined today, show lebri performing similarly when dosed every two or four weeks. Dupixent, meanwhile, is given every two weeks. The latest results build on 16-week data from the Advocate studies, which used the two-weekly dosing schedule – and showed lebri just about outdoing Dupixent. It will take a lot to get patients to switch from Dupixent, which is reflected in consensus forecasts from Evaluate Pharma: the sellside expects the Sanofi/Regeneron antibody to bring in $9.3bn in atopic dermatitis in 2028, versus lebri’s $1.5bn the same year. Still, Jefferies analysts reckon that, based on a physician survey, lebri could become the second most-prescribed biologic after Dupixent. But before the challengers can think about launch they will need to get the nod from regulators: Lilly and Almirall are planning filings in the US and Europe respectively later this year.
| Cross-trial comparison of lebrikizumab & Dupixent: proportion of previous responders maintaining EASI-75 at 1 year | |||
|---|---|---|---|
| Lebrikizumab | Q2W | Q4W | |
| Advocate-1 | 79% | 79% | |
| Advocate-2 | 77% | 85% | |
| Dupixent | Q1/2W | Q4W | Q8W |
| Solo-Continue | 72% | 58% | 55% |
| Source: Company release & JAMA Dermatology. https://www.evaluate.com/vantage/articles/news/trial-results-snippets/lebrikizumabs-convenience-edge-emerges | |||
ADA 2022 – Lilly’s triple-G is one to watch
Mounjaro might be the name on everyone’s lips following impressive recent results in obesity with the GIP/GLP-1, but a much earlier Lilly asset, LY3437943, is also worth keeping an eye on. The project is a so-called triple-G – an agonist of GIP, GLP-1 and glucagon receptors – and data from a phase 1 trial, presented at ADA yesterday, are encouraging. Though primarily a safety study of ascending weekly doses in a type 2 diabetes population, the study also measured blood sugar and weight. After three months’ treatment, mean HbA1c decreased from baseline in all groups, with higher doses of LY3437943 showing statistically significant placebo-adjusted decreases of up to 1.56%. The agent also prompted dose-dependent decreases in mean placebo-adjusted body weight of up to 8.96kg, and safety seemed acceptable, with the most common treatment-emergent adverse events being nausea and diarrhoea, which were mostly mild. The lack of a dose response on the HbA1c endpoint is perhaps puzzling, though patients numbers were small, with only nine to 12 subjects in each LY3437943 arm. Data from two larger phase 2 trials in diabetes and obesity could come this year, and might clarify the situation.
| Clinical trials of LY3437943 | |||
|---|---|---|---|
| Status | Details | Data | NCT ID |
| Phase 2 | Vs pbo in 494 patients w obesity/overweight | PCD May 2022 | NCT04881760 |
| Phase 2 | Vs Trulicity and pbo in 300 patients w type 2 diabetes | PCD Jul 2022 | NCT04867785 |
| Phase 1 | Vs pbo in 64 Japanese participants w type 2 diabetes | PCD Dec 2022 | NCT04823208 |
| Phase 1 | Vs Trulicity and pbo in 72 patients w type 2 diabetes | Hit at ADA 2022 | NCT04143802 |
| Phase 1 | Vs pbo in 45 healthy participants | Completed | NCT03841630 |
| PCD = primary completion date. Source: Evaluate Pharma. https://www.evaluate.com/vantage/articles/news/trial-results-snippets/ada-2022-lillys-triple-g-one-watch | |||
Asco 2022 – looking beyond Enhertu in Her2-low cancer
Enhertu continues to show that it can hit Her2-expressing cancer cells that other drugs cannot reach, priming the Daiichi Sankyo and Astrazeneca asset for dominance across the Her2 space. That means serious competition for players in what now must be called Her2 high. Roche has the most to lose here, although newer products will also suffer – the launch of Seagen’s Her2 kinase inhibitor Tukysa has already been stopped in its tracks after a mere two years by Enhertu’s arrival. In the newly defined Her2-low space there will also be repercussions. The impressive Destiny-Breast04 data likely consign Gilead’s Trodelvy to a last-resort option, given this ADC’s weaker showing in Tropics-02. What of others eyeing this niche? Not many active trials can be found on clinicaltrials.gov of agents specifically going after Her2 low. Most are ADCs – step forward again Seagen, which paid $200m up front for ex-Asia rights to Remegen’s Her2-targeted ADC, disitamab vedotin. Meanwhile, a trispecific from Sanofi and a radiotherapeutic from Bayer provide different mechanistic approaches to watch. Safety is Enhertu’s weak spot so there is room for improvement here; on efficacy, though, a high bar has been set.
Radius Expands Non-US Market Footprint for TYMLOS injectable
Globalization has been a key priority for the Company over the past two years
Three additional market agreements now signed and executed:
- Labatec Pharma SA: Switzerland, Middle East & North Africa (MENA) countries
- Pharmbio Korea Inc.: South Korea
- Biosidus: Colombia, South AmericaEconomics: upfront payments, regulatory & commercial milestones, and COGS margin
Adds 13 new countries to the current non-US countries of Japan and Canada
Japan: regulatory approval of 14-day cartridge anticipated in 2H 2022 followed by launch
Canada: regulatory decision expected by the end of 2022
EU and subsequently UK regulatory decisions expected in 2H 2022
https://finance.yahoo.com/news/radius-health-expands-non-us-120000852.html
Allogene: Regenerative Medicine Advanced Therapy (RMAT) Designation to Lymphoma Med
RMAT Designation Follows Positive Data from ALLO-501A ALPHA2 Trial in Heavily Pretreated Patients with Relapsed or Refractory Large B cell Lymphoma (LBCL)
Data Presented at the American Society of Hematology (ASH) 2021 Annual Meeting Demonstrated AlloCAR T™ Could be Safe and Effective in Producing Durable Responses
In the ALPHA Trials with ALLO-501 and ALLO-501A, Treatment was Initiated Approximately 2 Days from Enrollment, Eliminating Any Need for Bridging Therapy
Company Intends to Initiate a Phase 2 Pivotal Trial in Mid-2022
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