Centrexion Therapeutics has restarted its attempt to list on the Nasdaq. The Jeff Kindler-helmed biotech pulled the plug on a planned IPO late last year but now hopes to find investors more amenable to its bid to raise money for a phase 3 pain program.
The phase 3 is testing CNTX-4975, a synthetic form of the capsaicin molecule found in chili peppers, in patients with moderate-to-severe pain related to osteoarthritis of the knee. Centrexion expects to have data from the first of two planned pivotals trials in the first quarter of 2020, with results from the second study to follow later in the year.
Centrexion is yet to propose terms for the IPO but is aiming to raise enough money to see it through to the delivery of data from the first phase 3 trial. The company, which had $38 million in the bank at the end of June, aimed to raise around $90 million when it tried to go public last year.
In updating its IPO filing, Centrexion has added details of a suspected unexpected serious adverse reaction in an open-label trial it is running in parallel to the two pivotal studies. The subject, who had no known history of allergies, experienced life-threatening breathing difficulties just after receiving an injection of CNTX-4975. The investigator viewed the event as an acute allergic reaction.
The subject was immediately treated with epinephrine and methylprednisolone and recovered after a few minutes. After a follow-up consultation, an allergy specialist concluded the event did not match an allergic reaction. Vascular diffusion was proposed as an alternative explanation. The investigator initially categorized the event as treatment-related but later shifted position, concluding the drug was “possibly” involved.
Aside from that event, CNTX-4975 has largely been well tolerated. The most common adverse event in the open-label trial to date is procedure pain, which has affected 3% of the 581 subjects.
Based on the funding plan proposed last year, Centrexion is likely to use most of the IPO haul to pay for the phase 3 program. Centrexion plans to use some of the money to complete phase 1 trials of two other assets, CNTX-6016 and CNTX-6970. A fourth drug, CNTX-0290, was on the 2018 spending plan, but Centrexion has since offloaded it to Eli Lilly for $47.5 million upfront.