Clinical Results

PHASE 1 Clinical Study

Lyfaquin has a wide safety margin

Study Groups	Treatment
	*Single Ascending Dose (SAD)*
Cohort I	0.005 mg/kg of PMZ-2010 (n=3) & placebo (n=1)
Cohort II	0.01 mg/kg of PMZ-2010 (n=3) & placebo (n=1)
Cohort III	0.05 mg/kg of PMZ-2010 (n=3) & placebo (n=1)
Cohort IV	0.1 mg/kg of PMZ-2010 (n=3) & placebo (n=1)
	0.15 mg/kg of PMZ-2010 (n=1)
	*Multiple Ascending Dose (MAD)* Administered every 8 hourly for 02 days
Cohort V	0.033 mg/kg of PMZ-2010 (n=3) or placebo (n=1)
Cohort VI	0.067 mg/kg of PMZ-2010 (n=3) or placebo (n=1)

Therapeutic dose: 0.01 mg/kg body weight

Adverse events (mild) occurred at more than ten folds higher than therapeutic dose and resolved without sequelae/intervention in about an hour.

PHASE 2 Clinical Study

Lyfaquin is highly effective resuscitative agent and improves the outcome

Key Parameters	Overview
Trial N Size	50 hypovolemic shock patients 23 patients in the experimental arm, 22 patients in the comparator arm
Treatment Arms	Experimental Arm: Lyfaquin + Standard of care Comparator Arm: Standard of care alone
Therapeutic Dosage	Lyfaquin administered at 0.01mg/kg in 100 mL of normal saline
Safety & Efficacy Assessment over 28 days	*In Lyfaquin group:* Less fluid and vasopressors administration Increase in blood pressure Decrease in blood lactate Improved base deficit Lower MODS and ARDS Faster recovery, reduced ICU and ventilator time No mortality, while in control 9% mortality

PHASE 3 Clinical Study

Lyfaquin is highly effective resuscitative agent and improves the outcome

Key Parameters	Overview
Trial N Size	105 hypovolemic shock patients 71 patients in the experimental arm, 34 patients in the comparator arm
Treatment Arms	Experimental Arm: Lyfaquin + Standard of care Comparator Arm: Standard of care alone
Dosage	Lyfaquin administered at 0.01mg/kg in 100 mL of normal saline
Efficacy Assessment	Efficacy parameters were assessed over 28 days from randomization to a clinic visit

PHASE 3 Outcomes

Effect on Cardiac Output / Hypoperfusion

Transformational advantage over standard of care

Endpoints	Results(% of patients)
Systolic Blood Pressure ≥110 mmHg at 24 hours	Control: 60.61% Lyfaquin: 79.69%
Diastolic Blood Pressure ≥70 mmHg at 24 hours	Control: 51.52% Lyfaquin: 76.56%
Blood Lactate of ≤1.5	Control: 46.88% Lyfaquin: 69.35%
Base-Deficit of <-2.0 (mmol/L)	Control: 43.75% Lyfaquin: 69.84%
Mortality	Control: 11.76% Lyfaquin: 2.94%

PHASE 3 TRIAL OUTCOMES

Effect on MODS and ARDS

Significantly improved ARDS and organ function (MODS); key driver of mortality in hypovolemic shock

Acute Respiratory Distress Syndrome (ARDS)

Acute Respiratory Distress Syndrome (ARDS) was compared between day 1 (before resuscitation) and day 3 of resuscitation. In the control group of patients receiving standard treatment, the difference between means from day 1 to day 3 was -0.06247 ± 0.05030 (p=0.2171). On the other hand, in the centhaquine treated group of patients, the ARDS difference between means from day 1 to day 3 was -0.09927 ± 0.04891 (P=0. 0449). These results indicate that centhaquine treatment significantly improved ARDS following resuscitation, whereas there was a minor improvement in the control group.

Multiple Organ Dysfunction Score (MODS)

MODS was compared between day 3 and day 7 of resuscitation. There was no improvement in MODS in the control group, and the difference between means was 0.5893 ± 0.9370, whereas, in the centhaquine group, the difference between means was -0.5485 ± 0.3421. The change in control was towards worsening (MODS from 1.138 to 1.727), whereas, in centhaquine patients, it was towards improvement (MODS from 1.367 to 0.8182). The number of patients with 2 or more MODS score on day 7 were 45.45% in control and 13.64% in centhaquine groups (P=0.044; Odds ratio 5.278, 95% CI 0.852 to 23.32).

Clinical Results