Praxis Precision Medicines Inc PRAX-628 Program Update Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst : Good morning, team. Hope you can hear me.

Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst : Okay, thank you so much for confirming. Dr. Friedmann, thank you so much for your thoughtful analysis, and thank you to Praxis team for that outstanding data. Dr. Friedman, I think what would be really helpful if you could talk about the translation of the PPR study, two treatment effects of focal epilepsy. If you could maybe help us understand because I think a lot of investors on the call are trying to figure out with really 100% complete responses, what would that translate in a product profile, what would the efficacy be in seizure reduction? And you also noted that given the clean safety profile one can dose optimally high and further get cleanups, if you could talk about that, that would be really helpful. And then for the Praxis team, I guess what are the next steps here, right? With this data? What are the doses could you contemplate running two Phase 2b studies for potentially that could become pivotal? And if you could kind of give us some broad strokes of the design that would be helpful, and I'll jump back into the queue. Thank you again.

Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst : Got it. Thank you so much, and I'll jump back into the queue.

Question: Ritu Baral - Cowen & Co., LLC - Analyst : Good morning, guys. I want to add my congratulations on this data. Praxis team, could you go through the background meds that some of these patients were on? And then as you think about the Phase 3, we have spoken about the guidance that FDA has issued on Phase 3 development. But as you think of that design, given what Dr. Friedman said about the unmet need, teratogenicity, et cetera, are there any aspects of the Phase 3 design that you were thinking of that could clearly differentiate 628 from the landscape?

Question: Ritu Baral - Cowen & Co., LLC - Analyst : And a very quick follow-up, if I may. When 628 was added to patients with background meds, especially those at the same class, was there any increasing of severity of the side effects of note of mechanism, including fatigue, headache, et cetera? Thanks.

Question: Ritu Baral - Cowen & Co., LLC - Analyst : Thank you so much.

Question: Doug Tsao - H.C. Wainwright & Co., LLC - Analyst : Hi, good morning and congrats on the data. Maybe starting for the Praxis team, the PPR model is known to be very good for generalized epilepsy. And I think Dr. Friedman mentioned it, and I think you've sort of suggested that was an avenue in the past. And just curious how you're thinking about pursuing the generalized epilepsy opportunity. And then maybe for Dr. Friedman, I'd just be curious to hear his perspective on the unmet need for therapies in generalized epilepsy versus focal onset epilepsy. Thank you.

Question: Doug Tsao - H.C. Wainwright & Co., LLC - Analyst : Great. Thank you so much.

Question: Asim Rana - Truist Securities - Analyst : Good morning. Congrats on the data. This is awesome. I just have one quick question. Marcio, you mentioned going forward with a 20 milligram dose for the efficacy study. Just curious, given today's data, why not go with the 45 milligram dose or possibly higher given the tolerability of this PPR study? Thank you.

Question: Asim Rana - Truist Securities - Analyst : Thank you.

Question: Kambiz Yazdi - Jefferies LLC - Analyst : Morning, Marcio and team and congratulations on the result. Maybe Dr. Friedman, one question for you, what does the importance of therapeutic margins and speed of achieving therapeutic concentration for anti-epilepsy medications. And then maybe for the team, investors too, are curious about kind of the precise definition of a partial response, does that mean the kind of a limited range of frequencies of IPS stimulation there exposed to that they would not have a PPR? Thank you.

Question: Kambiz Yazdi - Jefferies LLC - Analyst : Thank you so much.

Question: Laura Chico - Wedbush Securities Inc. - Analyst : Good morning. Thank you for taking the questions. I have one clarification on the 15 meg patients moving into the 45 meg cohort. But first, I wanted to ask a little on AE with respect to sleep paralysis. Just any additional commentary there? And first on the sleep paralysis? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Laura Chico - Wedbush Securities Inc. - Analyst : Yeah. Thank you. So if I'm reading correctly, there were three evaluable patients in the 45 milligram cohort that came from the 15 milligram cohort. So I'm just trying to understand who the three patients from the 15 milligram cohort that moved into the 45 cohort, what were their responses in the 15 milligram?

Question: Laura Chico - Wedbush Securities Inc. - Analyst : Thank you.