Table 4.

Change from Baseline to Month 6 in Key Efficacy/Activity Parameters

	MLWHFQ VO₂ Max (mL·kg·min) 6MWT (m) NYHA Class NT-Pro BNP (pg/mL) ESV (mL) EF (%)

Cohort/Patient Identification	BL NAb	Visit	Obs	Chg	Obs	Chg	Obs	Chg	Obs	Chg	Obs	%Chg	Obs	Chg	Obs	Chg
Cohort 1/Pt# 1	<1:2	BL	54		17.3		408		3		315		162		30
		M6	39	−15	19.3	+2	549	+141	3	0	326	+3.5	131	−31	33	+3
Cohort 1/Pt# 2	*1:2*	BL	73		12.3		372		3		2329		233		18
		M6	79	+6	10.8	−1.5	366	+6	3	0	1640	−29.6	237	+4	16	−2
Cohort 1/Pt# 3	<1:2	BL	11		14.3		350		3		2928		245		25
		M6	12	+1	14.0	−0.3	439	+89	2	−1	1161	−60.4	178	−67	31	+6
Cohort 2/Pt# 1	<1:2	BL	34		13.0		466		3		1420		200		20
		M6	22	−12	14.7	+1.7	456	−10	2	−1	874	−38.5	229	+29	21	+1
Cohort 2/Pt# 2	<1:2	BL	35		10.2		276		3		5236		352		16
		M6^*	22	−13	ND	NA	276	0	2	−1	6061	+15.8	354	+2	13	−3
Cohort 2/Pt# 3	<1:2	BL	70		15.8		523		3		2596		204		25
		M6	45	−25	21.7	+5.9	627	+104	2	−1	2186	−15.8	174	−30	26	+1
Cohort 3/Pt# 1	<1:2	BL	28		17.1		311		3		770		279		21
		M6	12	−16	19.1	+2	348	+37	3	0	1203	+56	256	−23	21	0
Cohort 3/Pt# 2	<1:2	BL	30		16.0		519		3		458		275		22
		M6	47	+17					3	0	602	+31	242	−33	21	−1
Cohort 3/Pt# 3	*1:2*	BL	64		11.6		329		3		30704		265		18
		M6^†

BL, baseline or screening value; NAb, neutralizing antibody; MLWHFQ, Minnesota Living with Heart Failure Questionnaire; VO2 max, maximal oxygen uptake; 6MWT, 6-minute walk test; NYHA, New York Heart Association; ESV, end systolic volume; EF, ejection fraction; Obs, observed; Chg, change; M6, month 6; ND, not done; NA, not available.

Prespecified clinically meaningful changes per Table 2 are underlined. See Evaluation of Study End Points.

Data are available through Month 2 or 3 for Cohort 2/pt # 2 who died on Day 96; sudden death was assessed as unlikely related to investigational product. Month 6 data are last observations carried forward.

^†

Data are not available for Month 6 for Cohort 3/pt # 3 who received mechanical assist device at Week 6.