Invion ready to escalate dose in lupus trial

Invion (ASX:IVX) is ready to escalate the doses in its phase II trial of its INV103 drug candidate for lupus after reporting successful interim safety data.

Data from the first two of four planned cohorts have been analysed, with INV103 demonstrating a safety profile supportive of testing higher doses, the company said in a market update.

In the first cohort of mild lupus paients receiving 10 mg intravenous injections twice weekly, neither serum biomarkers nor stimulated cells showed any statistically significant pattern of response to INV103 due to baseline values at or near the normal range.

In the second 30 mg cohort, serum biomarkers likewise showed no statistically significant cohort-wide response to treatment.

Given the results to date, the company is now confident in escalating the dose again to 100 mg twice weekly for the next cohort.

Invion CEO Dr Greg Collier told Board Room Radio that this dose level represents a 10-fold increase over the highest dose used in previous clinical trials.

“[The results have] also enabled us to open some dialogue with the [US] FDA about testing this drug in more severe patients, particularly including lupus patients with renal disorders,” he said.

Invion chief medical officer Dr Mitchell Glass separately commented that escalating the dose and including patients with more severe disease will be critical to evaluating the efficacy of the drug.

“Patients with more severe lupus have higher levels of the biomarkers that we are examining and, accordingly, we would hope to see amelioration of these important biomarkers,” he said.

“We believe that the response from the final cohorts of this study will be pivotal for both regulatory strategy and possible partnering for INV103.”

Invion (ASX:INV) shares were trading 8.7% higher at $0.075 as of around 2 pm on Tuesday.