Biotech Stock Edesa Biotech (Nasdaq:EDSA) Gains on News of Additional Positive Results from Phase 3 Paridiprubart Study

The stock makes the Nasdaq top gainer list on news today, currently
trading at $1.5300, up 0.6310 on over 38 Million shares as of this
report. The stock has a morning  high of $1.60.

Edesa Biotech announced today positive additional data from a Phase
3 study of paridiprubart.

The results represent a broader, 278-patient population, which
includes both previously reported 104 patients requiring invasive
mechanical ventilation (IMV) as well as 174 non-IMV patients. Across
this full population, the company’s first-in-class anti-TLR4
antibody demonstrated a statistically significant reduction in
28-day mortality. Treatment benefits were consistent across severity
groups and in patients with serious comorbidities.

Key Findings

The primary endpoint was achieved for the full treatment population
of 278 randomized subjects. Paridiprubart reduced adjusted 28-day
mortality to 24% from 33%, a 27% relative reduction in the risk of
death (p<0.001). In addition, subjects receiving paridiprubart
demonstrated a higher relative rate of clinical improvement by Day
28. Paridiprubart or placebo were provided in addition to standard
of care treatments (SOC).

In an exploratory analysis of a milder population of 174 randomized
patients who did not meet the study’s IMV-based inclusion
criteria, paridiprubart + SOC reduced adjusted 28-day mortality to
15% from 23% (placebo + SOC), a 35% relative reduction in the risk
of death (p<0.05).

Edesa also reported that exploratory analyses across a patient
population of up to 108 randomized subjects consistently
demonstrated reduced adjusted mortality for paridiprubart + SOC vs.
placebo + SOC at 28 days in subjects with clinically important
comorbidities:

• 
  Acute Kidney Injury: 35% relative reduction (35%
  paridiprubart vs. 53% placebo; p<0.05, n=48)
• 
  Sepsis: 36% relative reduction (40% paridiprubart
  vs. 63% placebo; p<0.05, n=41)
• 
  Pneumonia: 30% relative reduction (35%
  paridiprubart vs. 49% placebo; p<0.05, n=108)

Overall rates of adverse events, serious adverse events, infections
and treatment discontinuations were low and similar between the
paridiprubart and placebo groups. The safety profile was consistent
with prior clinical exposures, with more than 400 patients now
having received paridiprubart.

Based in part on these positive results, Edesa has filed provisional
patent applications with the United States Patent and Trademark
Office covering the use of paridiprubart in the treatment of sepsis,
acute kidney injury and pneumonia. The company’s core
composition-of-matter patents extend into the 2030s.

Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said
that the results announced today align with the central role of TLR4
in hyperinflammatory ARDS (Acute Respiratory Distress Syndrome) and
demonstrate consistent benefit across high-mortality etiologies.

“The consistency of mortality reduction and clinical
improvement across all 278 randomized patients, including less
severe patients as well as those with ARDS complicated by acute
kidney injury, sepsis and pneumonia, underscores the versatility
and transformative potential of paridiprubart to address multiple
critical unmet medical needs,” said Dr. Nijhawan. “We
are advancing regulatory discussions and evaluating strategic
collaborations and partnership opportunities that could accelerate
development and broaden global access.” He noted that
manufacturing scale-up planning is underway.

Full news 

https://ca.finance.yahoo.com/news/edesa-biotech-reports-additional-positive-141500282.html