Paradigm Biopharmaceuticals Ltd (ASX: PAR) shares are taking off on Wednesday.
In morning trade, the ASX biotech stock is up 11% to 29 cents.
Why is this ASX biotech stock surging?
Investors have been buying the late-stage drug development company's shares this morning after it made a big announcement.
According to the release, Paradigm has received a detailed response from the U.S. Food and Drug Administration (FDA) following the Type D meeting response submitted to the agency in April.
The company advised that the response from the FDA comprises a detailed set of comments that provides a pathway for progression of its phase 3 clinical program for knee osteoarthritis (OA).
What was the FDA's response?
The release reveals that the FDA has confirmed that Paradigm's phase 2 clinical data (PARA_005 and PARA_OA_008) supported the safety and tolerability of the twice weekly 2 mg/Kg dose, and that the clinical monitoring for adrenal effects will continue.
The regulator has also provided detailed guidance for the use of the company's selected dosing regimen of 2mg/kg injectable pentosan polysulfate sodium (iPPS) administered twice weekly.
Management believes this is a "significant outcome" for Paradigm. This is because it feels that based on the clinical data generated to date, with a dosing regimen of 2mg/kg iPPS administered twice weekly, the phase 3 clinical trial is best set up for success.
In addition to feedback on the dosing regimen, the FDA has provided feedback on amendments to the monitoring and mitigation plan, and statistical guidance. The good news is that management believes these changes were supported by clinical and nonclinical data generated in its clinical development programs to date. As a result, it intends to implement these changes and submit the updated protocol under the open Investigational New Drug (IND) application currently in place with the FDA.
Once the protocol is submitted, Paradigm expects a 30-day review period before proceeding with enrolment for the PARA_OA_012 trial.
'One step closer'
Commenting on the news, the ASX biotech stock's managing director, Paul Rennie, said:
I understand that many investors are eager to know the dosage that will be used in the pivotal phase 3 clinical trial. I am pleased to announce that the FDA has indicated our clinical data supports the safety and tolerability of the twice-weekly administration of 2 mg/kg, the same dosing regimen Paradigm used in its phase 2 clinical studies (PARA_005 and PARA_OA_008). We would like to extend our gratitude to the US FDA for their valuable guidance on the phase 3 protocol.
Paradigm's chief medical officer, Dr Donna Skerrett, added:
I believe the clarity provided by the FDA's response has brought us one step closer to entering the pivotal phase of the program. We now have a clearer and more certain path forward, enabling us to optimize the clinical protocol. We are incredibly proud of the collaborative efforts and hard work that have led us to this point, and we are excited to move forward with a protocol designed to maximise our chances of success. The alignment with the FDA's guidance further strengthens our confidence as we progress towards a successful outcome, bringing us closer to achieving our goal of securing approval for iPPS.
