Pharvaris N.V. Ordinary Shares 12th Annual Cantor Fitzgerald Global Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- Pharvaris reported successful Phase III prophylaxis data for their drug Decrypt Event in hereditary angioedema (HAE), following a prior Phase III success in on-demand treatment in December last year.
- The Phase III study showed an 87% attack rate reduction in type 1 and type 2 HAE patients, exceeding Phase II results, attributed to an improved extended-release formulation providing sustained drug exposure.
- The study included a diverse patient population from six continents, with a higher baseline attack rate than Phase II, demonstrating efficacy in a more severe patient group.
- Decrypt Event is the only orally available B2 receptor antagonist suitable for both on-demand and prophylaxis treatment of HAE types 1, 2, and 3, as well as acquired angioedema, with plans to broaden indications.
- Safety data showed one serious adverse event of laryngeal dyskinesia in a type 3 patient, which was clarified as a vocal cord disorder unrelated to swelling; liver function test elevations were observed but without bilirubin increase or symptoms, consistent with background patient factors.
- Pharvaris plans to launch the on-demand product in April next year, followed by the prophylaxis indication after filing and regulatory review.
- The company is building a commercial organization with a US sales force targeting approximately 2000 physicians, aiming for a strong launch and integration of on-demand and prophylaxis products.
- Pricing strategy will consider the portfolio to maximize uptake, with flexibility to potentially price on-demand at a discount to encourage prophylaxis use.
- Pharvaris is preparing filings for acquired angioedema indication with top-line data expected in Q1 next year, potentially included in the prophylaxis filing to seek priority review.
- Management highlighted the unmet need for oral HAE therapies and expects Decrypt Event to become the leading oral prophylactic treatment, capturing new patients and those currently on injectable therapies.
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Transcript
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Okay, great. Welcome, everyone, to the next session of the Cantor Fitzgerald Global Healthcare Conference. I'm Steve Seedhouse on the biotech team here at Cantor. It really is a privilege to welcome a team less than 48 hours, I guess, or very shortly after their second phase III success within the last year. This is Pharvaris. I'm joined by many of the team members up here, and maybe I can have them introduce themselves as they make their introductory remarks. Berndt Modig, CEO, maybe I can start with you.
Yeah. We can go down the line.
Would love to just, as you've had time to reflect on the phase III prophylaxis data in HAE for deucrictibant, how are you feeling about the results and what's been the reaction?
Yeah. Obviously incredibly excited about seeing that, and also on top of the phase III result on the band that we had in December last year. It really makes us very excited about the future for deucrictibant. Rewinding a little bit, I came into this therapeutic area 23 years ago with the company that developed icatibant, and already back then we saw the potential unmet need for an oral. So 10 years and now four months ago, we set out to, basically from scratch, to develop a molecule with the same MOA as icatibant, a B2 receptor antagonist, with the vision of improving the lives of people living with hereditary angioedema. Really excited to say also, to our knowledge, deucrictibant is the only orally available B2 receptor antagonist out there.
Not only that, but because of the properties, as we know, it makes it suitable both for on-demand and prophylaxis. So with one molecule, we have two products to cover and meet all the needs of people living with HAE. So now with that data, we'll talk more about it in a minute, then we are looking forward to get launching this, and we are already well underway with our on-demand launch predicted for the 8th in April next year. Follow then after we have filed and with the review on the prophylaxis, also to launch the prophylaxis indication. We're also aiming to broaden the application of deucrictibant in not only HAE 1 and 2, but also type 3 and a condition called acquired angioedema, for which there's nothing approved today. Bradykinin-mediated angioedema is really the focus of ours.
I will bring in President Peng Lu as well, and Chief Commercial Officer Wim Souverijns, and maybe have an intro question for each of you as well. I guess, Peng, summarize, did anything surprise you or really your take on the efficacy and the safety side? In particular on the safety side, maybe you can address, we keep getting a lot of questions about LFT elevations and there was one quirky patient that had this laryngeal dyskinesia, I think. Maybe address some of that upfront, just to clarify any confusion that people might have had from that, because I think obviously holistically the data was terrific.
Sure, yeah. Thanks, Steve. Actually, as everyone see our top-line readout, we do have one serious adverse event reported that Steve has mentioned is the laryngeal dyskinesia. Actually, everyone is chasing around to see what the dyskinesia means there. Actually, it is a vocal cord disorder that once around the time when we see this case, this patient is hospitalized, we reach out to the site and to the investigator to understand more. Actually, this is a normal C1 patient. That is the first time we include normal C1 patients in this trial. Prior to joining the CHAPTER-3 study, this patient observed 19 laryngeal attacks before joining the study within the 3 months. This patient is almost frequent visit to the ER to get intubation, because as you know, that a vocal disorder can be triggered by the frequent intubation.
There are some factors, some triggers, that can lead into this disorder. That is why that while the patient hospitalized, that we checked disorder, there is also because patient in the trial, they did the laryngeal microscopy there. There is no any swelling. That is why it is exclude this is a laryngeal attack. Then the patients get better, and actually, the doctor shared more information with us. Since this patient joined the CHAPTER-3 study, of course, the doctor doesn't know the patient on active treatment or on the placebo. He only mentioned to us the patient reduced attack 90%, that laryngeal attack. The patient are very happy, joined the study, and even back to work. Because in the past, there are so many laryngeal attacks happens, he always have to visit the ER there. She cannot work. She is a pharmacist.
But she is so happy to join the study and start the new chapter of life. That is why make us, at least myself, feel really proud that deucrictibant really can help the patients with unmet medical need there to really get the new life for the patients.
This is a Type 3 patient, which of course- This is a Type 3 patient.
are not even enrolled in the other studies.
Yeah. Okay. How are we going to launch this drug, Wim?
Stellar launch it's going to be.
Okay. The team is super excited.
I joined 5 years ago, and to really be at the verge of really getting in the hand of the doctors and the people that need this is super rewarding. I think we got all the I sometimes say deucrictibant is the product that keeps on giving.
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