BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR) (OTCQB: BETRF) (FRA: NPAT) is pleased to provide an update on the proposed acquisition of Altum Pharmaceuticals Inc. (“Altum”) and its upcoming clinical programs. A Special Meeting of Altum shareholders, more than 72% of whom have signed a Lock Up Agreement, is scheduled for July 29th 2020 to approve the merger with BetterLife. The results of the vote will be announced shortly thereafter.
Altum reports that in May 2020 management requested a pre-IND meeting with the FDA with the intent to discuss the planned development of AP-003 (Interferon Alpha-2b for inhalation) for the treatment of COVID-19. In a broad ranging interaction covering nonclinical, CMC and clinical aspects, the FDA has responded and provided clear and implementable guidance that can lead to a successful IND filing upon completion of one additional nonclinical study.
“We are pleased with the feedback from the FDA which provided guidance on non-clinical, CMC and clinical aspects of Altum’s proposed plan to initiate an AP-003 COVID-19 development program,” said Ahmad Doroudian, Chief Executive Officer of BetterLife and Altum. “The FDA also encouraged further interactions as we near the IND filing.”
Dr. Doroudian added, “This guidance from the FDA clearly lays out the steps that we have to take to move AP-003 forward so that it reaches the clinic for the treatment of COVID-19, where we believe it holds tremendous promise. Our operations, regulatory and clinical teams are working towards initiation of clinical trials in the next 2 to 3 months.”
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Dr. Doroudian concluded by stating that the Company will release more detailed clarification on feedback from the FDA and on its planned human trials immediately after the vote on July 29th, 2020.
Cautionary Note
The Company is not making any express or implied claims that Altum’s AP-003 or any other product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time. Further, the safety and efficacy of Altum’s AP-003 are under investigation and market authorization has not yet been obtained.
Source: biospace
