by: Parent Project Muscular Dystrophy
Today, Solid announced that the second patient has been dosed in the higher dose cohort of the IGNITE DMD Phase I/II clinical trial of SGT-001, the company’s AAV gene transfer candidate under investigation for Duchenne. We are excited to see continued momentum in this trial and, as always, are grateful to the families participating in this exciting potential therapy.
Solid’s Letter to the Duchenne Community:
Dear Duchenne Community,
We were grateful for the opportunity to connect with so many Duchenne families at PPMD’s Annual Conference at the end of June in Orlando and have the chance to present an update on our IGNITE DMD clinical study. We would like to provide a further update to keep you all informed with the progress of the study.
Today, Solid announced that the second patient has been dosed in the higher dose cohort of the IGNITE DMD Phase I/II clinical trial of SGT-001, an AAV gene transfer candidate under investigation for Duchenne. As a reminder, this higher dose cohort is receiving a single administration of SGT-001 at 2E14 vg/kg, which is four times higher than our starting dose.
Solid has also made protocol amendments to the IGNITE DMD clinical study. One change includes adding an upper weight limit of 25 kg for at least the next patient dosed in the second cohort. Solid remains committed to dosing larger patients in the future. Another protocol amendment is the removal of the matched patient control arm for the rest of the second cohort. We believe these protocol changes will speed up the path to obtaining IGNITE DMD clinical trial results. As always, Solid understands the urgency in advancing meaningful therapies responsibly with the goal of impacting the broadest population of patients affected by Duchenne.
In other recent news, Solid announced in July that the company had raised $60 million in financing, strengthening our financial position.
Solid continues to anticipate providing a data update from the IGNITE DMD clinical trial later this year and we look forward to sharing all progress with the community.
Sincerely,
The Solid Biosciences Team
Click here to read the full letter.
Read Solid’s Press Release:
Solid Biosciences Reports Second Quarter 2019 Financial Results and Provides Business Update
August 14, 2019 at 7:25 AM EDT– Additional patient dosed at 2E14 vg/kg in second cohort of IGNITE DMD trial –
– Study protocol amended to expedite clinical execution of SGT-001 –
– Recent $60M capital raise extends runway into the fourth quarter of 2020 –
CAMBRIDGE, Mass., Aug. 14, 2019 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB) today reported financial results for the second quarter ended June 30, 2019 and provided a business update.
“We continue to execute on our mission to bring transformative therapies to patients with Duchenne muscular dystrophy, and we have taken several steps towards reaching our goal,” said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. “We have amended the IGNITE-DMD protocol to expedite our clinical path evaluating our SGT-001 gene transfer candidate and have treated a second patient in our higher dose cohort. We also bolstered our financial resources and extended our runway. Looking forward, we continue to anticipate providing a data update from the IGNITE DMD clinical trial in the months ahead.”
Recent Developments
- Solid has amended the IGNITE DMD Phase I/II trial protocol for SGT-001, an adeno-associated viral gene transfer candidate under investigation for Duchenne muscular dystrophy (DMD). The changes to the protocol include adding an upper weight limit of 25 kg for at least the next patient dosed in the second cohort and removing the matched patient control arm for the rest of the second cohort in the IGNITE DMD trial. Solid expects that these protocol updates will expedite the path to obtaining IGNITE DMD clinical trial results as well as the broader development of the SGT-001 program. Solid remains committed to dosing larger patients in the future. The company intends to provide a data update from the ongoing IGNITE DMD clinical trial later this year.
- Today, Solid announced that the second patient has been dosed in the higher dose cohort of the IGNITE DMD clinical trial.
- As announced previously, the company raised $60 million through a private placement, which closed on July 30, 2019. Participants included a mix of new and existing investors, including Perceptive Advisors, LLC; Boxer Capital, LLC; EcoR1 Capital, LLC; Bain Capital Life Sciences; RA Capital Management; Waverly Capital; Invus and certain board members and executive officers.
